Changes of the chemical composition of authorised plant protection products
Date: 3 June 2020
readPlant protection products are mixtures of one or more active substances and so called co-formulants. The chemical composition of a plant protection product determines not only its physico-chemical properties but also the environmental behaviour as well as toxicological and eco-toxicological properties. Consequently a change in composition may influence and alter these properties. Therefore, the process of a composition change is strictly regulated (SANCO/12638/2011, 20 November 2012 rev. 2). A revision of this guideline is available as draft (rev. 3, 29.11.2019), which is more detailed that the previous one.
This draft guideline specifies three types of changes (one is a two tiered approach) versus two categories in the recent guideline. Type 1 and Type 2 (Tier 1) of the new guideline are non-significant changes in the recent guideline, while Type 2 (Tier 2) and Type 3 are significant changes.
Type 1 changes are administrational changes (e.g. Typos or error correction, improvement in a.s. purity, etc).
Adding equivalent co-formulants or replacing co-formulants by equivalent ones are Type 2 changes. The evaluation of this type of change is a two-step process. The CAS numbers of the co-formulants and the classification and labelling should be identical (Tier 1). If this is not the case, a Tier 2 assessment based on the comparison of specific physical-chemical or technical properties of the old and new PPP are needed. This might require physical-chemical studies.
Type 3 changes are changes, where co-formulants are exchanged, added, omitted or whose content is changed. Depending on the extent of the changes, new studies on toxicological and eco-toxicological properties might be required.
In the case of Type 1 changes a notification to the authorities is sufficient, while in the case of Type 2 (Tier 1 and Tier 2) or Type 3 an application for an amendment of the authorisation is required. Type 1 changes should be approved by authorities within three months, whereas the two other types will take six months for the assessment.
Article 36 (3) Zonal examination for product authorization and the possibility of an individual rejection of a cMS due to an unacceptable risk
Date: 2 June 2020
readReg. (EU) 1107/2009 Article 36, states the conditions of evaluation with regards to the zonal authorization procedure, where one Member state examines the application on behalf of the other Member States (concerned Member States or cMS’s) within the zone. In principle, this Member State is responsible for the authorization within a zone and decides on the authorization or rejection or admission restrictions in accordance with Reg (EU) 1107/2009 Art. 35 for all cMS’s where core issues are concerned.
However, Reg. (EU) 1107/2009 Article 36 paragraph 3 opens up the possibility for the concerned Member States to take different authorization decisions based on their respective national issues, both in the zonal authorization procedure as well as in the framework of mutual recognition.
Article 36 (3) states that: “Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment.”
This gives the concerned Member States the opportunity to set their own national authorization conditions and if this is not sufficient as a protective measure, to refuse the authorization.
In summary, Member states of concern in a zonal product authorization procedure are allowed to reject the authorization of a product in their Country if the risk is considered unacceptable.
Date: 1 June 2020
readFor every active substance, a specification is set during the evaluation process which includes the minimum purity of the active substance and the maximum contents of impurities. Impurities are divided into significant (content of 1 g/kg or more in the technical material) and relevant impurities (substances of (eco-)toxicological concern; max. content is set based on their (eco-)toxicological properties). A specification is generally based on the results of a 5 batch study. The limits for the individual components are derived from the found mean values minus (for the active substance) or plus (for impurities) three standard deviations. A five batch study must include data of 5 representative batches from the manufacturing plant (also called source) and the selected batches must not be older than 5 years. The specification which is set based on the source evaluated during the EU review is referred to as the reference specification and the evaluated manufacturing plant as the reference source.
If an applicant wants to use technical active substance produced at further manufacturing plant(s), a 5 batch study must be provided for each additional plant. This is also required if a change from a pilot to industrial scale is undertaken or if the manufacturing process is changed. It must be shown that the material from the additional plants does not exhibit a greater (eco-)toxicological concern than that of the reference source. The evaluation of material from additional sources is called the evaluation of technical equivalence. The guideline for this assessment is SANCO/10597/2003 –rev. 10.1 which is based on Article 38 of Regulation (EC) 1107/2009. The evaluation of technical equivalence is process is divided into two steps: Tier 1 and Tier 2.
The Tier 1 evaluation is a comparison of the content of the individual components in the technical material. The evaluation is completed if the following criteria are fulfilled:
- The minimum purity of the new source is not lower than that of the reference source
- No new impurities are present
- The increase of significant impurities is not more than 3 g/kg (if the max. content is 6 g/kg or less) or not more than 50% (if the max. content is higher than 6 g/kg)
If these points are met, no further evaluation is required and the new source is technically equivalent to the reference source.
If equivalence cannot be shown based on a Tier 1 assessment alone, a Tier 2 assessment becomes necessary. In this case the toxicity of the new (or increased) impurities must be assessed by additional data. Depending on the identity of impurities under discussion (for example, whether or not it is a known substance of concern) the additional data to be provided can be limited to a theoretical assessment (e.g. quantitative structure-activity relationship (QSAR) models) or new studies must be provided (e.g. an AMES test either with the technical material from the new source or the impurity). If the additional data shows that the technical material from the new source does not possess higher toxicity than that of the reference source, technical equivalence is shown based on the Tier 2 assessment.
A harmonized system for product notifications across the EU – timeline, procedure and pitfalls
Classification, labeling, and packaging (CLP) of substances and mixtures according to Commission Regulations (EC) No 1272/2008 and (EU) 2017/542
Date: 29 May 2020
In order to protect consumers as well as the environment from potentially hazardous properties of chemical products, a harmonized classification, labeling, and packaging strategy was introduced in the EU with Regulation (EC) No 1272/2008. In particular, it defines that manufacturers, importers as well as downstream users are legally obliged to provide comprehensive information on their products (e.g. toxicological information, chemical composition) to the authorities. This is also relevant for information provided on MSDS (material safety data sheets) and requires expert consultation.
The legal foundation of these product notifications is defined in Article 45 of Regulation EC (No 1272/2008) introduced above. Due to differences in the realization of the European regulation in EU member states, harmonization and validity of product notifications across the EU has however been limited. This problem has been addressed with the implementation of Commission Regulation (EU) 2017/542 amending CLP Regulation (EC) No 1272/2008. This amendment (often simply referred to as Annex VIII CLP) defines a harmonized format for notifications of products for submission to the appointed bodies in each member state. With this Annex, not only the content, but also the technical format has been clearly defined in a legally binding way. In a first revision to Annex VIII dated January 2020, adjusted compliance dates for product notifications have been published for professional use products (January, 1st 2021) and for products for industrial use (January, 1st 2024). Please note that January, 1st 2021 applies to plant protection products.
Key aspects that need to be included in the new product notifications include for example a product specific UFI code (Unique Formula Identifier) as well as more comprehensive toxicological information, and a new Product Category System (PCS). ECHA (European Chemicals Agency) provides a tool which assists in the generation of UFI-codes and additionally, user-guides with detailed information on the procedure of UFI-Code generation and PCS are available for download from https://poisoncentres.echa.europa.eu.
Submission of product notifications may be done using the new EU harmonized Poison Centres Notifications Portal (PCNP) which facilitates submissions to more than one EU country. Currently, this new system is however only in place in Estonia and Germany, and harmonization across all EU countries has not yet been implemented. Thus, product notifications shall be done using the respective national notification portals and guidelines until December 31st 2020.
A guidance document for the correct preparation of product notifications according to the new PCN (Poison Centre Notification) format is available for download from ECHA, too.
Common mistakes by notifiers that occurred in the past include, among others, incomplete data on product/mixture composition, incomplete information regarding e.g. hazard statements, CAS number, and inconsistent data sets.
Even though the new system for product notifications is still in its infancy and currently only available in Germany and Estonia, it has the potential to provide a straightforward EU-wide harmonized system for product notifications which will make processes more efficient, and additionally will facilitate the acceptance of product notifications across the EU.
Date: 28 May 2020
readCo-formulants are substances or preparations used in plant protection products which are neither active substances nor safeners or synergists. According to Article 27 of Regulation (EC) No 1107/2009, it is intended to include a list of co-formulants which should not be permitted in plant protection products as an Annex to the Regulation (Annex III). For a long time this annex did not contain any entries which is why national lists were published by several countries. Early in 2020 a draft list of unacceptable co-formulants was published by the European Comission which includes 90 entries.
According to the corresponding draft regulation amending Annex III, co-formulants are considered unacceptable if they have harmful effects on human or animal health or on groundwater or an unacceptable effect on the environment. Therefore, co-formulants with the following properties are undesirable:
- Classification as carcinogens, category 1A or 1B, as cell mutagens, category 1A or 1B, or as toxic to reproduction, category 1A or 1B, in accordance with Regulation (EC) No 1272/2008
- persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) in accordance with Regulation (EC) No 1907/2006
- endocrine disrupting properties in accordance with Regulation (EC) No 1907/2006 or substances identified as endocrine disruptors under Regulation (EC) No 528/2012
- restricted use as co-formulant in plant protection products according to Annex XVII of Regulation (EC) No 1907/2006
For plant protection products containing an unacceptable co-formulant, their registration is intended to be withdrawn no later than 2 years after entry into force of the respective Regulation. The grace period for sale and distribution is foreseen to be 3 months, and additional 9 months for storage, use and disposal after withdrawal of the products.
While unacceptable co-formulants may not be added to plant protection products, it is recognized that traces of unacceptable co-formulants might be present as unintentional impurities in other co-formulants. Therefore, the individual concentration in the finished plant protection product is generally limited to 0.01% w/w (unless otherwise stated).
The draft regulation amending Annex III had been open for commenting until 13 February 2020. A date for adoption has not yet been provided.
Date: 27 May 2020
readAccording to Article 2(3)c of Regulation (EC) No 1107/2009, co-formulants are "substances or preparations which are used or intended to be used in a plant protection product or adjuvant, but are neither active substances nor safeners or synergists”. Apart from the active substances, plant protection products therefore contain co-formulants which give the product the necessary properties for application such as solvents, carriers, inert material, wetting agents, etc. and which are supposed to have a positive effect on production, storage or use of a product. Co-formulants in turn can consist of several components.
All co-formulants which are contained in the formulation of a plant protection product have to be characterized by the applicant or the manufacturer when an application is made for authorization. Co-formulants deemed to have an unacceptable harmful effect on human/animal health or on the environment, will not be permitted to be included in plant protection products as specified in Article 27 of Regulation (EC) No 1107/2009. A list of the co-formulants whose use is not permitted in plant protection shall be provided in Annex III of Regulation (EC) No 1107/2009 but up to now this annex has no entries. Nevertheless, the EU draft regulation implementing the list of co-formulants that shall not be used in plant protection products is under discussion. After entry into force of the list Member States must withdraw authorizations of products containing any of the listed unacceptable co-formulants at the latest by 2 years.
For a transitional period the Member States can continue to apply national provisions for co-formulants. For example in Germany, a series of toxicologically or ecotoxicologically relevant co-formulants have been replaced in plant protection products over the past few years on national level. This means that plant protection products containing a co-formulant mentioned in the accordant "List of unwanted co-formulant substances" have no prospect of being authorized in Germany.
In the other hand Germany provides also a list of 1654 co-formulants in alphabetical order of their commercial names which are contained in authorized plant protection products and the composition of which is sufficiently known to the Federal Office of Consumer Protection and Food Safety (BVL). For these co-formulants information on the composition is usually not needed. It is sufficient if a current safety data sheet is submitted with the application for authorization.
Date: 26 May 2020
readAdjuvants are substances used to enhance the efficacy or other properties of plant protection products and thus, shall fall also under the scope of the EU plant protection Regulation 1107/2009.
Considering the current needs of agriculture in the EU e.g. with respect to reduction of dose rates for plant protection products, adjuvants used as mixing partners are a valuable tool for agricultural practice. Therefore, according to Article 58(2) of Regulation 1107/2009 defining the placing on the market and the use of adjuvants, an additional regulation should be adopted providing “detailed rules for the authorization of adjuvants, including data requirements, notification, evaluation, assessment and decision making procedures” but such a regulation on adjuvants is currently still not available.
Accordingly, registration of adjuvants is still the objective of national plant protection laws of the EU Member States. In consequence, registration procedures for adjuvants vary hugely between countries. The differences between registration procedures established in the Member States apply to the data requirements as well as the administrative procedures.
With respect to data requirements some member states like Germany have no or very low data requirements besides a detailed analysis of the composition of the product as well as of the composition of possible co-formulants used in the adjuvant. On the other hand the procedure established for adjuvant registration e.g. in France is quite similar to the authorization procedure for plant protection products according to Regulation 1107/2009 including the submission of a draft registration report and, if applicable, studies for all relevant sections such as e.g. physical chemical parameters and analytics, toxicology, ecotoxicology and efficacy.
Administrative procedures for adjuvants also vary between the Member States. This applies not only for a direct application for authorization but also for procedures such as mutual recognition or the authorization of generic products. In Germany for example, mutual recognition is not possible, whereas France accepts both procedures in addition to a direct application for authorization. Thus, in France adjuvants are already handled more or less in compliance to Regulation 1107/2009 considering data requirements as well as administrative procedures whereas in countries such as Germany the registration procedure is still a national issue.
Short introduction to the Japanese system to register agrochemicals
Date: 25 May 2020
readLike in the EU, a system to register agrochemical products is also in place in Japan. For people familiar with the process and history of registrations in EU, the current registration process in Japan is reminiscent of the national – i.e. Member State specific - registration legislation before Council Directive 91/414/EEC became effective.
In Japan, registering an agricultural chemical is regulated by the Agricultural Chemical Regulation Act (Act No 82 of 1948, last version amendment No 53 of 2018). The procedure described in the regulation act does not differentiate between active substance and product as is the case in the EU. Active substance data is required for registration of a product, but no separate procedure for approval of an active substance exists.
Manufacturers and importers of agricultural chemicals must submit an application for registration via the Incorporated Administrative Agency Food and Agricultural Materials Inspection Centre (FAMIC) to the Minister of Agriculture, Forestry, and Fisheries (MAFF), accompanied by documentation to confirm the quality and safety of the relevant agricultural chemical. This includes various test results concerning the efficacy against diseases and pests, negative effect on crops, toxicity to humans and non-target organisms as well as residue in crops. Historically, strong emphasis is given to maximum residue levels and consumer exposure.
The data requirements and test guidelines for these tests are specified by the notification No.12-Nousan-8147 and notification No.13-Seisan-3986 as well as notification No.13-Seisan-3987 and notification No.13-Seisan-3988. For applicants usually dealing with applications in EU or US, they should be considered carefully, as they vary from requirements in the EU or US. For field studies it is important to note that they are usually only accepted if performed in Japan. Good laboratory praxis (GLP) is established in Japan and has to be respected for studies to be considered reliable like in EU.
The data necessary for registration is presented to the authorities in the standard OECD dossier format, as detailed in notification No.26-Shoan-537.
The evaluation is coordinated by the Ministry of Agriculture, Forestry, and Fisheries, who directs FAMIC to evaluate, whether the relevant agricultural chemical is suitable for registration. FAMIC then reports back to Ministry of Agriculture, Forestry, and Fisheries. Further, the Ministry of Health as well as the Ministry of Environment are involved by establishing standards for withholding the agricultural chemical registration. These standards are threshold values (such as e.g. maximum residue levels) that the agricultural chemical must not exceed. Otherwise, registration will be withheld (thus the name as “Standards for withholding registration”). If the agricultural chemical meets the requirements, the Ministry of Agriculture, Forestry, and Fisheries grants registration.
According to the Agricultural Chemical Regulation Act, re-evaluation of the registered products is conducted upon request from the Ministry of Agriculture, Forestry, and Fisheries and all products containing the same active substance are re-evaluated simultaneously. Compared to the system in EU where active substances are re-evaluated, the Japanese regulation chooses a way in between, where products grouped according to their active substance are re-assessed. Therefore, even though products are formally re-registered, the re-evaluation is active substance based. Again, as indicated in the first paragraph, for those familiar to the history of and the changes in regulatory affairs in the EU, this intention to review all existing products / active substances is highly reminiscent of the review of existing active substances under Council Directive 91/414/EEC in EU.
For microbial pesticides, special guidance exists in form of the notification No.9-Seisan-5090.
Withdrawal or amendment of an authorisation
Date: 22 May 2020
readAn existing authorisation of a plant protection product may be withdrawn or amended based on two possible procedures:
1.) On request of a Member State, according to Article 44 of Regulation (EC) No 1107/2009)
Whenever a Member State has an indication that the requirements for a product authorisation are not or no longer satisfied, a review of the authorisation is possible.
Explicitly stated as one possible reason is, that a review shall be done where the objectives of the framework for Community action in the field of water policy in regards to surface water, groundwater and drinking water may not be achieved (Directive 2000/60/EC, Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3)).
Possible reasons for withdrawal or amendment of an authorisation after review are:
In addition, the Regulation specifies without further defining that a withdrawal or amendment is possible, where the authorisation holder fails to comply with the obligations resulting from Regulation (EC) No 1107/2009.When withdrawal or amendment of an authorisation is intended, the Member State shall inform the authorisation holder and give the opportunity to comment or to table further information.Once an authorisation is withdrawn or amended by a Member State, respective information has to be sent immediately to the authorisation holder, other Member States, the Commission and EFSA. Other Member States of the same political Zone shall also withdraw or amend the authorisation accordingly, whenever the reasons for withdrawal/ amendment are not based on national conditions or risk mitigation measures of the initial Member State only.2.) On request of the authorisation holder, according to Article 45 of Regulation (EC) No 1107/2009A request for withdrawal or amendment of an authorisation may be raised by the authorisation holder. The request has to be justified.Prerequisite for an amendment of an existing authorisation is the maintenance of compliance with the requirements for a product authorisation (specified in Article 29).
- The requirements for product authorisation (Article 29) are not or no longer satisfied
- The granted authorisation was based on false or misleading information
- A condition included in the authorisation has not been met
- The manner of use and amounts used can be modified based on developments in scientific and technical knowledge.
For both cases it is stated in Article 46, that a grace period for the sale and distribution (max. 6 months), and for disposal, storage and use of existing stocks (additional max. 1 year) may be granted, provided that the reasons for withdrawal/amendment are not related to the protection of human and animal health or the environment.
Maximum Residue Levels (MRL)
Date: 21 May 2020
readThe abbreviation MRL stands for “maximum residue level”, which describes the highest legally tolerated level of a pesticide residue remaining in food or feed. MRL are regulated by Regulation (EC) No 396/2005 on “maximum residue levels of pesticides in or on food and feed of plant and animal origin and shall guarantee safe food and feed”. For the setting of MRLs, active substance properties and the conditions of use (GAP) for the plant protection product are reviewed and the calculations consider the safety of all consumer groups, e.g. children or vegetarians. MRLs apply to fresh products as well as processed products.
Please note that MRLs are not set for all active substances. Exceptions are listed in Annex IV of Regulation (EC) No 396/2005 and include for example “foodstuff” or chemicals and natural materials of very low toxicity.
MRLs are also important for imported crops grown in third countries outside of the EU, e.g. exotic fruits. In these cases, the legislation in the exporting countries can differ to the European law. For example, plant protection products might be authorised and used in third countries, which contain active substances not approved in the EU. To guarantee the high safety level of goods in the EU, such commodities can only be imported if they do not exceed a specific MRL set as import tolerance. The setting of import tolerances can for example be requested by producers of active substances or by traders who would like to export/import respective commodities.
Date: 20 May 2020
readIn 2009 a new type of substance category was introduced in the EU legal framework for plant protection, the so-called basic substances.
Active substances have to fulfil certain requirements to be eligible for classification as basic substance, i.e. the substance is not a substance of concern, does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects, is not predominantly used for plant protection purposes but nevertheless is useful in plant protection either directly or in a product consisting of the substance and a simple diluent and is not placed on the market as a plant protection product. Furthermore, the substance shall have neither an immediate or a delayed harmful effect on human or animal health nor an unacceptable effect on the environment. Examples for basic substances are onion oil, vinegar, beer or sunflower oil.
The approval procedure for basic substances deviates from the procedures for low risk or conventional active substances. The application for the approval of a basic substance is submitted by a Member State or by any interested party directly to the Commission. The application has to include for example any evaluation of its possible effects on human or animal health or the environment carried out in accordance with other Community legislation regulating the use of the substance as well as any other relevant information on its possible effects on human or animal health or the environment. On its part, the Commission asks EFSA for an opinion, or for scientific or technical assistance.
Basic substances are approved for an unlimited period. However, the Commission can review the approval of a basic substance at any time. It may take into account the request of a Member State to review the approval. Where the Commission considers that there are indications that the substance no longer satisfies the criteria the approval may be withdrawn or amended.
According to Article 28(2a) of Regulation 1107/2009 on the authorisation for placing of plant protection products on the market, for basic substances no product authorisation is required for the “use of products containing exclusively one or more basic substances” whereat for basic substances product is defined as “consisting of the substance and a simple diluent” (Article 23 (1c)). Interestingly, the working document on the procedure for application of basic substances (SANCO/10363/2012 rev.9 of 21 March 2014) clearly states that “any other products deviating from the definition of Article 28(2)(a) containing for example an already approved “basic substance” and a co-formulant shall have to be considered as plant protection product. Therefore, in compliance with Article 2 [defining the scope of Regulation 1107/2009] in that case the substance will constitute the “active substance“. In such case, the substance needs to be approved as active substance. An application accompanied by a dossier in compliance with Article 8 [defining active substance dossiers] of the Regulation will have to be submitted”.
Basic substances automatically qualify for use in organic farming.
Date: 19 May 2020
readIn the EU, there are a variety of bodies involved in management, evaluation and execution of legislation concerning active substances and plant protection products. The following alphabetical list is a short overview, neither comprehensive, nor exclusive and focusses only on tasks for plant protection, disregarding all other areas.
CIRCABC: Communication and Information Resource Centre for Administrations, Businesses and Citizens, an application used to create collaborative workspaces where communities of users can work together over the web and share information and resources. It is used to share public administration documents. There is also a non-public part for Member States (CIRCA - Communication and Information Resource Centre for Administrations), which they us as a platform to share evaluation reports for plant protection products.
COM: European Commission also referred to as EC, exercises executive powers – such as upholding EU treaties and managing day-to-day business – but not legislative ones other than legislative initiative. For plant protection, the COM issues the legislative initiative, i.e. proposal for inclusion/non-inclusion in Annex I on which the SCoPAFF will vote. COM then adopts the legislation, if it was accepted by SCoPAFF.
Council: Council of the European Union, also Council of Ministers, one of the legislative bodies which amends and approves proposals from the European Commission together with the European Parliament. It is composed of the national ministers (one per state) and meets in 10 different configurations, depending on the topic under discussion. Usually, it is not directly involved in plant protection legislation. However, in the recent glyphosate case, political discussion was moved from SCoPAFF to the Council.
DCG: Director´s Consultation Group; initiated by the central zone Steering committee. It consists of the authorities’ directors of the central zone (i.e. head of plant protection department of national authorities) to monitor the harmonisation process and to come to decisions if working groups on zonal level cannot arrive at an agreement for plant protection products.
DG SANTE: Directorate-General for Health and Food Safety, before 2014 called DG SANCO, develops and carries out the Commission’s policies by implementation of European Union laws on the safety of foods and public health. It issues important guidance on the implementation of plant protection regulations.
ECHA: European Chemicals Agency; with respect to plant protection, it takes care of classification and labelling for active substances. It is therefore involved in preparing Vol 1 of assessment reports for active substances.
EFSA: European Food Safety Authority, prepares scientific evaluations, co-ordinates peer-reviews of the assessment report issued by the rapporteur member state for active substances. Issues the EFSA conclusion on which COM proposals for active substances are based.
EP: European Parliament, adopts European legislation, normally on a proposal from the European Commission as it does not hold legislative initiative. It is directly elected by the European citizens and currently has 705 members. It is not directly involved in plant protection legislation, but recently issued a non-binding resolution in the glyphosate case and starts various political initiatives.
EUCO: European Council, comprised of the head of states of all EU members. It is not involved in plant protection legislation.
PAI: Post approval issues, expert group which counsels the SCoPAFF.
SCoPAFF: Standing Committee on Plants, Animals, Food and Feed. The PAFF Committee is composed by representatives of all EU countries and presided by a COM representative. It delivers opinions on draft measures that the COM intends to adopt and aids the COM in initiating legislation. Here, votes on the COM’s initiatives for inclusion/non-inclusion in Annex I are taken.
zSC (izSC, nzSC, czSC, szSC): zonal Steering Committee (interzonal, northern, central, southern), strive for coordination and cooperation between the national authorities in the Member States, coordinate zonal procedures for evaluation of plant protection products.
BREXIT – Influence on EU procedures and national UK procedures
Date: 18 May 2020
readThe withdrawal of the United Kingdom from the European Union, based on the UK-wide referendum in June 2016, entered into force on 31 January 2020. During the subsequent transition period until 31 December 2020, negotiations about the future relationship between the UK and the EU Member States are taking place (this paragraph reflects the status at 5th May 2020).
With entry into force of the BREXIT and the beginning of the transition period UK became a “third country” (non-EU and non-EEA). This change of the status of UK influenced the procedures for active substances and plant protection products in the EU:
- According to EU law, UK could no longer act as rapporteur Member State (RMS) for active substance evaluations, evaluating Member State (EMS) for MRL related procedures, or zonal rapporteur Member State (zRMS) for plant protection product registrations.
- The European Commission published in 2018 a notice, encouraging business operators to take necessary actions to choose another Member State as evaluator for new applications. For on-going procedures, where it was already conceivable or it could not be ruled out that the evaluation conducted by UK would not be finalised before withdrawal, business operators were advised to change the Member State within the procedure.
- For active substances where the UK was already in place (evaluation not finalised until withdrawal) or was foreseen as rapporteur or evaluating Member State the Commission has re-allocated the position to another Member State.
- As of the withdrawal date, the United Kingdom cannot be a reference Member State in the mutual recognition procedure. Business operators need to apply for an authorisation based on an existing product authorisation in another Member State. However, where an authorisation has been granted under the mutual recognition procedure before the withdrawal date, this authorisation is not affected by the withdrawal.
- With date of the withdrawal, parallel trade permits granted in the past for parallel trade from UK to another Member State are no longer valid. Plant protection products benefiting from such parallel trade permit can therefore no longer be placed on the market in the particular Member State.
For business operators intending registrations in UK, HSE released following information for procedures during the transition period (among others):
- Existing active substance approvals and MRLs remain valid and new EU active substance approval and EU MRL decisions will apply to the UK.
- The EU technical equivalence of any new source of active substance included in applications where authorisation will be completed during the transition period would need to have been approved in the EU.
- Existing product authorisations remain valid. New “UK only application” will be considered against the current EU rules and standards. On-going applications (started before withdrawal) where the UK is concerned Member State will be completed to conclude a national UK decision. For this purpose, the applicant may need to provide HSE with the finalised EU registration report once available.
- Applications under Article 40 (mutual recognition) for UK national authorisation are accepted.
- Existing parallel trading permits for PPPs remain valid. HSE will continue to accept applications for parallel trading permits until the end of the transition period.
Information about future procedures in UK was not yet released. If and how far a future cooperation between UK and the EU with regard to plant protection related procedures will take place has to be decided within the negotiations during transition phase. Confronted with the Covid-19 pandemic and thus aggravated circumstances for negotiations a prolongation of the transition phase could be conceivable, but not yet requested.
Safeners & Synergists
Date: 15 May 2020
readBeside active substances, plant protection products may contain safeners or synergists which are also in the scope of Regulation (EC) No 1107/2009. According to Article 2.3 of this Regulation, safeners and synergists are defined as:
- Safeners: “Substances or preparations which are added to a plant protection product to eliminate or reduce phytotoxic effects of the plant protection product on certain plants”
- Synergists: “Substances or preparations which, while showing no or only weak activity […], can give enhanced activity to the active substance(s) in a plant protection product”
According to Article 25 of Regulation 1107/2009, the same conditions for the approval of safeners and synergists as for active substances shall apply. However, the regulatory procedures for the registration of such substances and preparations are not established yet and data requirements, as already available for active substances and plant protection products, have to be defined for safeners and synergists. Therefore, for the time being, national frameworks have to be used for registration of respective substances and preparations.
Although no harmonised EU requirements for the approval of safeners and synergists exists, a (national) authorisation is mandatory for placing safeners and synergists on the market.
Date: 14 May 2020
readIn general, for the registration of micro-organisms – living, inactivated or their metabolites – different regulatory frameworks may apply in the EU. The present overview focusses on their use in plant protection products, bi-ostimulants or fertilisers and does not consider uses in e.g. biocidal products, food, feed, human or veterinary medicine although such uses and the respective regulatory frameworks may influence registration possibilities under plant protection or fertiliser laws.
There are two primary criteria which determine the regulatory framework applicable for the specific micro-organism or its metabolite(s) – plant protection or fertiliser.
In regards to the first criterion, claims, definitions and restrictions given by the respective framework regulations, the amendment to the Plant Protection Products Regulation 1107/2009 of 5 June 2019, induced by Regulation 2019/1009 laying down rules on the making available on the market of EU fertilising products, are of special importance. Accordingly, if a product is used for “protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products” or if the product is used for “influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient or a plant biostimulant”, the product falls under the plant protection product regulatory framework. Regulation 2019/1009 further defines “plant biostimulant” as “a product stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: (a) nutrient use efficiency; (b) tolerance to abiotic stress; (c) quality traits or (d) availability of confined nutrients in soil or rhizosphere”. Currently, the new EU fertiliser/Biostimulant Regulation, which entered into force in June 2019 and will be applicable from July 2022 onwards, considers microbial-based biostimulants to be products containing “micro-organisms, including dead or empty-cell micro-organisms and non-harmful residual elements of the media on which they were produced, which (a) have undergone no other processing than drying or freeze-drying and (b) belong to the following genera or groups: Azotobacter spp., Mycorrhizal fungi, Rhizobium spp. or Azospirillum spp”. It remains to be seen if and/or which other micro-organisms will be included in the positive and negative lists of Regulation 2019/1009.
The second major criterion is the existing regulatory background, i.e. existing approvals and authorisations and the respective substance claims and Mode of Actions for similar microbial strains or related species, genera or functional groups. Differentiation in this regard may be especially difficult due to biological/physiological simi-larities between strains to be registered. Modes of Action known for one strain/species may be transferred to other strains/species based on their biology and thus assignment to a regulatory framework may be predestined by previous/existing registrations. Scientific evidence, e.g. based on whole genome analysis, and scientific ar-gumentation are then required to be able to register under a different regulatory framework. As already stated above, respective strain/species characteristics may also be due to registrations in regulatory frameworks not considered in this article e.g. use as biocide. This applies not only for the micro-organism itself but also to func-tional groups of metabolites.
Data Sharing and vertebrate studies
Date: 13 May 2020
readUsually, data protection is granted for submitted studies on Member State level and it is not possible for other applicants to refer to this data in the respective Member State without approval from the data owner. At the same time, applicants are asked to avoid duplicate testing as stated in Article 61 of Regulation (EC) No 1107/2009, and therefore studies can be shared by a letter of authorisation from the data owner, granting prospective applicants the right to use the protected data for a product registration. Interestingly, there is no limit to which studies this applies as set out in Article 61. The use of protected data can be restricted to reference only, where the prospective applicant is not allowed to have insight into the study reports and can only use the results, or full access to the study reports can be granted.
A data owner is not obliged to share protected data with other applicants – with one major exception. For data generated using vertebrates (referred to as vertebrate studies), Article 62 of Regulation (EC) No. 1107/2009 specifies that such studies must not be repeated and authorities will not accept a duplicate vertebrate test. It is the responsibility of the applicant to verify that those test and studies have not already been performed or initiated. This includes active substance data such as livestock metabolism studies as well as product data such as acute toxicity studies. The reason behind this clause is that animal welfare weighs heavier than data protection claims.
For vertebrate studies, the data owner and a prospective applicant should make every effort to ensure that they come to an agreement to share such data. Compensation for the data owner should be determined in a fair, transparent and non-discriminatory way. The prospective applicant is only requested to share the costs of information required for the intended authorisation.
In the event, where the prospective applicant and the data holder cannot come to an agreement, the respective Member state authority should be informed. However, the failure to reach an agreement does not prevent the Member State authority to make use of the vertebrate studies for the purpose of the application of the prospective applicant.
Date: 12 May 2020
readData protection for plant protection products is specified in Regulation (EC) No 1107/2009, Article 59. It is defined as „the temporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant”. Data protection is always granted on Member State level and therefore applies to the data submitted for the authorisation of a product in one specific Member State. As underlying data for the active substance is also submitted for product authorisation, this data can also be protected. To make sure that studies used in the approval of active substances on EU level gain data protection later on Member state level, a list of claims is included in the application for the approval of the active substance.
Data protection can be claimed for test and study reports, if they fulfil the following requirements: The underlying studies have to have been performed according to good laboratory praxis (GLP) or good experimental practice (GEP) and the reports have to be considered necessary for the authorisation or an amendment of an authorisation in order to allow the use on another crop. Therefore, a GLP-study submitted, but not considered necessary by evaluators, is not eligible for data protection, as the authorisation is possible without this study.
For new active substances and products, the period of data protection is 10 years in general, starting at the date of first authorisation of the product in a Member State. There are only a few exceptions, where other applicants may be allowed to refer to protected data for their product authorisations during that time (see also the next online academy article on data sharing and vertebrate studies). Data protection can be extended for each minor use by three month (if the extension of authorisation is not based on extrapolation and if the application is made within the first five years after first authorisation), but never exceeding 13 years in total.
If new studies are submitted for the renewal of an active substance or review of an existing product authorisation, the new studies will be protected for 2.5 years. Studies from the first authorisation will no longer be protected as the protection time span has elapsed.
As an incentive to promote low risk plant protection products, the data protection period granted is a maximum of 15 years.
The fact that data protection is based on the authorisation date of the product in a specific Member State even for active substance approval or renewal studies might lead to some confusion as the protection time can vary between different countries. It is possible that a certain study is protected in one country, but not or no longer protected in another one, starting already with the different evaluation times between zonal Rapporteur Member State and concerned Member States. Also considering delays in evaluations, handling and determination of data protection is often a challenge. This should be taken into account for product registration strategies.
Date: 11 May 2020
The reliable archiving of data, study reports, submissions and corresponding documents has become a complicated and complex task in the regulatory world. This demanding task requires transparency and quick access, while assuring the accuracy of the entries and associated information.
For more than thirty years, since SCC's establishment in 1989, the data management and archiving of client information has been a top priority. Starting out with a simple database system, SCC has continually improved and refined this data management system to its current status, an exclusive data management and archiving software:
Electronic Document and Dossier Management System (EDDMS)
EDDMS can be used for all regulatory submissions: for chemicals (REACH), plant protection products, biocides, pharmaceuticals, consumer products, or any other type of product. This flexible system allows you data access on individual PCs, computer networks, or on a global scale. The administration of the data allows for a complete overview of what kind of data is in the archive, to whom it was submitted, and when.
The solution for your data management, EDDMS provides you with the following features:
- Data administration, including the direct viewing of integrated electronic files resulting in cost and time savings.
- Data presentation, allowing as well the retrieval (export) and presentation of the archived data in any format to fit the specific requirements of regulatory authorities.
- Tracking of studies, giving submission information and allowing for tracking through the administrative channels within the regulatory authorities.
- Comprehensive search and archiving functions, and the use of SCC's specially developed indexing system, adapted to the needs of the regulatory world.
- Study compensation and multiple user needs can be easily fulfilled for task forces and consortia. By using the EDDMS client manager, access rights can be defined in detail. Complete records or selected data boxes can be hidden or shown for respective users.
- Simplified compilation of electronic dossiers (e.g. CADDY).
EDDMS is a flexible system, available to clients via password protected online access.
EDDMS is easy to use: basic searches, retrievals and print-outs can be mastered quickly. Intermediate and advanced features can be quickly learned and implemented, providing complete data management and archiving for you, the client!
Article 51 – minor uses
Date: 8 May 2020
readArticle 51 REGULATION (EC) No 1107/2009 sets out the conditions under which extensions of authorizations for minor uses can be applied for. Besides other issues to be considered, authorizations can be extended for minor uses if e.g. the extension is in the public interest and the intended use is minor in nature, taking into account that these individual requirements are set nationally by the single member states. Accordingly, the criteria and guidelines for determining what constitutes a minor use vary amongst member states, keeping also in mind that all aspects related to the authorizations of minor uses are product issues and not those relevant for active substances.
In order to address the complex minor use facts in a more coherent way the European Commission (EC) has established the EU Minor Uses Coordination Facility (MUCF) which shall support farmers in the EU to produce high quality crops by filling minor uses gaps through efficient collaboration to improve availability of chemical and non-chemical tools. Accordingly, the term ‘minor use’ describes situations where the need for, and the use of, a plant protection product is relatively small. Typically these situations encompass crops grown on a small scale, high value or speciality crops e.g. most vegetables, fruits and ornamentals (also classified as ‘minor crops’), but can also involve the need for plant protection products on infrequent pests and diseases in major crops. Minor (or speciality crops) have a high economic value for producers, but are usually of low economic interest for the plant protection industry, considering the costs for development and authorization and keeping in mind the low acreage of minor crops which results in an insufficient return on investment of the expenditures that are required to attain regulatory approval. This situation leads to a lack of authorized products on the market to be used on minor crops which in turn can lead to illegal uses or to loss of crop production.
The requirement to generate a considerable amount of data would make the authorization process quite expensive for minor uses. In order to still have a sufficient number of crop protection products available, it is therefore possible e.g. to rely on fate or ecotoxicity data provided for major uses or to submit just a reduced amount of efficacy data. This includes also the option to explore other possibilities for determining the efﬁcacy and crop safety of a plant protection product, e.g. by case-by-case extrapolation of authorizations given to major crops to minor crops in order to simplify the registration process.
Additionally, the "minor use" aspect can also have a considerable influence on important regulatory issues such as Comparative Assessment or the classification of an active substance as Candidate for Substitution.
Mutual recognition – A time saving approach
Date: 7 May 2020
readPlacing a plant protection product (PPP) on the market is a very time and cost consuming procedure. Thus, the REGULATION (EC) No 1107/2009 provides a more efficient system – the mutual recognition (MR). Thoughts behind this system are that an authorization already granted in one Member State (MS) can be used for the authorization in another MS. This is based on the assumption that any assessment already done by one MS shall not be repeated by another MS, except for clearly defined issues.
The procedure for MR is clearly described in Article 40-42 of REGULATION (EC) No 1107/2009 and under point 3 of SANCO/13169/2010. There are three situations for which MR is possible or can be applied for, respectively, with the prerequisite that the reference authorization needs to have been granted in accordance with Article 29 REGULATION (EC) No 1107/2009:
- Authorizations between MSs belonging to the same zone
- Authorizations between MSs belonging to different zones with the provision that this authorization is not used for mutual recognition in another MS within the same zone (avoiding a “domino effect”)
- Authorizations between any MS where the application concerns use in greenhouse, post-harvest treatment, treatment of empty rooms or containers used for storing plants/plant products or seed treatment
Additionally, a number of cases are described for which MR is optional (Article 41.2), e.g. PPP contains a substance, which is included in the list of candidate for substitution, or the application concerns a provisional authorization, or the application concerns a product containing an active substance for which there are no alternatives (i.e. derogation according to Article 4.7). Further special cases are low-risk products or the extension of a minor use from one MS in another MS under the precondition that the product has a regular authorization in both MS.
The difference between the zonal evaluation and MR is that although in both cases the MSs have 120 days after completion of the zonal RMS evaluation to decide on authorization or refusal, the submission of the dossier for MR is not bound to the submission date to the zonal RMS. Additionally and in accordance with Article 36.3 of REGULATION (EC) No 1107/2009, the assessment of the MS shall be focused on “its specific environmental or agricultural circumstances. MR only applies for the same already granted product with the same uses under comparable agricultural conditions. Whilst there may be some flexibility to accept slight chances, more significant changes within an application would be dealt with as new zonal approach.
Date: 6 May 2020
readFor the use of a plant protection product for seed treatment it is foreseen in Article 33 of REGULATION (EC) No 1107/2009 that only one Member State shall evaluate the application for all zones. Mutual recognitions, generally only possible for countries where the reference Member state is located in the same political zone, are explicitly mentioned as possible from any Reference Member State of the EU.
The draft “Guidance document on the authorisation of plant protection products for seed treatment” (SANCO/10553/2012) is currently under revision. However, the draft document stresses that for the evaluation and authorisation process of a plant protection product intended for seed treatment the evaluation of the treatment process of seed (operator exposure studies and model calculation) and the evaluation of the sowing process in the field (dust occurrence during sowing or drilling) has to be considered.
According to Article 49 of the Regulation, placing on the market and use of seeds treated with plant protection products authorised for a specific use in at least one Member State shall not be prohibited, unless there are substantial concerns that treated seeds are likely to constitute a serious risk to human or animal health or to the environment. The label and related documents for treated seeds shall include at least the name of the plant protection product used for seed treatment, the name(s) of the active substance(s), standard phrases for safety precautions and risk mitigation measures set out in the product authorisation, and, in addition, any national requirement.
Serious danger to plant health
Date: 5 May 2020
readThe Article 4 (7) of REGULATION (EC) No 1107/2009 provides information about a special case for approval of active substances. It states: “Where on the basis of documented evidence […] an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II [meaning: classifications as carcinogenic and/or toxic for reproduction, or the presence of endocrine disrupting properties in regards to mammalian toxicity or ecotoxicity].”
Such an approval is only possible under the premise that risk mitigation measures are taken for the use of the active substance to minimise exposure of humans and the environment. Moreover, maximum residue levels have to be set. Furthermore this exemptional approval may only be applied where the active substance is not classified as carcinogenic category 1A or carcinogenic category 1B without a threshold, or as toxic for reproduction category 1A.
Plant protection products containing an active substance approved on basis of the above may only be authorised on Member State level, when there is a necessity to control a serious danger to plant health in the respective country. The Member State is obliged to develop a plan to control the respective serious danger for plant health by any other means (including non-chemical methods) for phasing out the product, which must be communicated to the EU Commission.
Thus, with respect to the above mentioned conditions the evidence for control of a serious danger to plant health may provide a (time-limited) possibility for a “second life” of an active substance falling under the cut-off criteria (separate article in our online academy).
Efficacy requirements for existing active substances (EAS)
Date: 4 May 2020
readAs already explained in Academy Article “Efficacy requirements for new active substances”, issued on Wednesday, 16th of April, the detailed focus of efficacy issues is on the authorization process of the plant protection products and less on the approval process of active substances. Nevertheless, certain efficacy aspects have to be addressed in the data package to be submitted for the approval process of new active substances with the accordant efficacy data requirements laid down in the Guidance Document SANCO/10054/2013.
Compared to the efficacy information to be submitted for a new active substance, the accordant data requirements for existing active substances within the renewal process are further reduced. According to draft Guidance Document SANCO/2012/11251, the dossier to be submitted for renewal of approval should just include an overview of the efficacy information concerning the uses already authorised in Member States with this overview to be based on the format provided in Guidance Document SANCO/10181/2013. This means that the range of supported uses should reflect a representative use pattern and including the uses evaluated for the first approval. The efficacy data compilation has just to consider formal requirements, including e.g. the description of function and mode of action, application details and basic resistance information.
Considering that the substance is approved and authorisations of plant protection products containing the substance have already been evaluated according to the Uniform Principles (Regulation (EC) No 546/2011), no other efficacy documentation is considered to be necessary for the renewal process.
Article 53 – Emergency situations in plant protection
Date: 1 May 2020
readRegulation 1107/2009 has a subsection dealing with “Derogations”, i.e. situations when the strict rules of the Regulation do not apply as strictly as they are laid down in the previous sections. Article 53, the first article in this subsection, deals with emergency situations. It stipulates that in an emergency situation to plant protection or ecosystems that cannot be managed by any other reasonable means, Member States may grant the authorisation for a plant protection product by the way of derogation from Article 28 of the regulation (EC) 1107/2009. Please note: this measure is a Member State issue and your application should be addressed to the relevant Member State … but you also have to enter the application into the European electronic “Plant Protection Products Application Management System (PPPAMS)”. And though Member States are fully responsible when granting such authorisations, these are reviewed at Community level.
Such an authorisation is limited for a period not exceeding 120 days. It is for a controlled and limited use and also defines the amount of product that might be sold under this derogation.
Accompanying information that might be asked by the authorities are, for instance, a description of the danger and the plant or crop situation, the type and danger to the plant production or ecosystem, size and effect of danger, the absence of any other reasonable means, mitigation measures or whether formal applications according to the Regulation are in progress or which research activities are on-going. Last (not least) a supporting letter by e.g. growers associations in the respective country is helpful (and sometimes necessary).
Date: 30 April 2020
readFertiliser product registrations in EU are subject to different regulatory frameworks. Currently only mineral fertilisers are regulated by a harmonised Regulation (REGULATION (EC) No 2003/2003). Fertilisers compliant with this regulation do not require a registration and can be brought freely onto the market in all EU Member States.
As part of the EU Circular Economy Action Plan, from 2022 onwards, additional product types such as biostimulants, organic fertilisers, liming materials, soil improvers or growing media will also be subject to harmonised rules. The respective REGULATION (EU) No 2019/1009 already entered into force in August 2019 but will only apply from 16 July 2022 onwards, as during the next years respective guidelines and registration procedures have to be developed. Until applicability of these harmonised rules, all fertilising products including plant aids, soil aids, biostimulants etc. are subject to national frameworks.
National rules can vary hugely between Member States. In certain countries, most fertilising products can be brought freely onto the market. Other Member States, such as Germany and Austria, require registration of products not compliant to the national positive lists whereat for most products only a product analysis in regards to nutrient and heavy metal contents is necessary. In other countries, such as France or Spain, data/study requirements may be higher depending on the type of product and can include toxicity or efficacy studies.
Based on the European Treaty and the free movement of goods in EU, mutual recognition of product registrations between Member States also applies for fertilising products. However, due to the different registration requirements, certain restrictions apply in some Member States. Therefore, regulatory applicability of the mutual recognition procedures has to be evaluated in detail in the product registration strategy. After applicability of the new harmonised rules from 2022 onwards, national registration procedures and mutual recognition will generally stay in place and complement the harmonised rules provided for by REGULATION (EU) No 2019/1009.
Anke König - Wingenfeld
Category 4 studies (CAT 4)
Date: 29 April 2020
readIn the renewal of authorisations according to Article 43 of REGULATION (EC) No 1107/2009, data might be missing due to several circumstances which can be divided into five categories (SANCO/2010/13170 rev. 14). One of them, category 4, is the need to fulfill new data requirements that will be applicable at the date of submission of product re-authorisation according to Art 43 or if endpoints of the active substance have changed. For example: a new residue definition decided upon in the active substance renewal will require new residue trails, which have to be included in the Art. 43 submission to uphold existing uses in the product registration. Another example would be the change in ecotoxicity endpoints for the active substance, leading to higher Tier studies to refine risk assessments for existing uses.
Since time, usually 3 month after renewal of the active substance, might be too short to generate such new data and because applicants often cannot foresee these circumstances, extra time to conduct these so called “category 4 studies” (CAT 4) and for generating the draft Registration Report (dRR) can be requested. The exact procedure has to be discussed with the zonal Rapporteur Member State (zRMS), but the prolongation can be up to 2 years (in exceptional cases even longer), depending on the type of study needed. The prolongation will start at the date of the active substance renewal. Therefore, discussion with the zRMS regarding CAT 4 studies should be undertaken when the EFSA conclusion for the renewal of the active substance is available and the need for CAT 4 studies becomes obvious.
Low Risk active substances and products
Date: 28 April 2020
readContrary to several non-EU regulatory frameworks, the EU Plant Protection Product REGULATION (EC) No 1107/2009 does not include a specific definition for biological or natural active substances or products. Rather, the EU Regulation differentiates between conventional and low risk active substances and products irrespective of their natural, biological or chemical origin. Updated criteria for low risk active substances are provided in REGULATION (EU) No 2017/1432. According to this Regulation, an active substance, other than a micro-organism, shall not be considered as being of low-risk where it corresponds to any of the following:
In addition, an active substance, other than a micro-organism, shall not be considered as being of low-risk where it is persistent (half-life in soil is more than 60 days) or its bio-concentration factor is higher than 100. However, a naturally occurring active substance which does not correspond to any of points (a) to (d) may be considered as being of low-risk, even if it is persistent (half-life in soil is more than 60 days) or its bio-concentration factor is higher than 100. Furthermore, an active substance, other than a micro-organism, emitted and used by plants, animals and other organisms for communication, shall be considered as being of low- risk where it does not correspond to any of points (a) to (d).
An active substance which is a micro-organism may be considered as being of low-risk unless at strain level it has demonstrated multiple resistances to anti-microbials used in human or veterinary medicine whereat baculoviruses shall be considered as being of low-risk unless at strain level they have demonstrated adverse effects on non-target insects. Additional criteria for micro-organisms are currently under development.
On product level, all products containing only low-risk active substances can be authorised as low-risk plant protection products.
Low risk active substances and products are encouraged by regulatory authorities. Applicants receive benefits, such as extended approval periods and data protection, while fees can be tremendously lower (depending on Member state). Moreover, the evaluation time for low-risk plant protection products is 120 days, which is shorter compared to conventional plant protection products.Carla Lorenz
Date: 27 April 2020
readThe Article 34 of REGULATION (EC) No 1107/2009 deals with the exemption from the submission of studies when applying for authorisations of plant protection products in accordance with Article 33(3) [see Academy Article “Zonal approach”].
Here some pre-requisites are necessary:
The applicant either needs access to the studies (Letter of access) still data protected or the respective data protection period of the studies has expired. In addition, the plant protection product must be comparable to an authorised reference plant protection product in the respective Member state, which was evaluated in accordance with the currently valid uniform principles.
Unfortunately, there is no harmonised approach for an application in accordance with Article 34. Some Member states insist on a full dossier. For other Member States reduced requirements are possible. In the latter case only some specific dRR parts must be submitted. In a very limited number of cases an administrative process (without dossier) is possible.
Date: 24 April 2020
readAccording to Regulation (EC) No 1107/2009 an active substance can only be approved if it is not or has not to be classified as hazardous according to the cut-off criteria (for further information please refer to Academy Article “Cut-off criteria”), unless the exposure of humans to that active substance in a plant protection product, can be considered as negligible, under realistic proposed conditions of use, meaning under conditions in agricultural practice.
The term “negligible” reflects that a plant protection product is used in conditions excluding exposure of humans to this specific active substance and that any possible residues of the active substance on food and feed items do not exceed the default value of 0.01 mg/kg set in accordance with Regulation (EC) No 396/2005.
According to the draft technical guidance SANCO/2014/12096, the negligible exposure has to be shown for a) dietary exposure and b) non-dietary exposure.
Even if negligible exposure can be shown for an active substance, it can nevertheless only be approved as candidate for substitution and the approval will only be granted for a period not exceeding seven years.
Currently the draft technical guidance SANCO/2014/12096 does not give any guidance for consideration of negligible exposure for non–target organisms (other than humans). Accordingly, there is no need of assessments of potential negligible exposure for such non-target organisms.
Date: 23 April 2020
readAnnex II of REGULATION (EC) No 1107/2009 (points 3.6, 3.7 and 3.8) provides information about hazardous properties under which an active substance, safener or synergist (mentioned hereafter as “substance”) cannot be approved, the cut-off criteria.
These criteria are specified as a substance being:
- Carcinogenic (category 1A or 1B; Annex II, point 3.6.3)
- Mutagenic (category 1A or 1B; Annex II, point 3.6.2)
- Toxic for reproduction (category 1A or 1B; Annex II, point 3.6.4)
- Persistent, Bio-accumulative and toxic for the environment (PBT; detailed criteria listed in Annex II, point 3.7.2)
- A persistent organic pollutant (POP; detailed criteria listed in Annex II, point 3.7.1)
- Very persistent and very bio-accumulative (vPvB; detailed criteria listed in Annex II, point 3.7.3)
- Or endocrine disruptive (detailed criteria listed in Annex II, point 3.6.5 for impact on human health and 3.8.2 for ecotoxicology)
For the criteria of being mutagenic, PTB, POP and vPvB a strict exclusion of the substance on the basis of the hazard is foreseen and no approval can be granted.
For substances being carcinogenic, toxic for reproduction and/or endocrine disruptive an approval can be granted, under the premise that human exposure or exposure of non-target organisms is negligible under realistic proposed conditions of use (e.g. use in greenhouses or in storage rooms). Moreover, in case of a serious danger to plant health where no other possibility for control is available, such a substance may be approved for a limited period under certain conditions (separate article in our online academy).
The Good Laboratory Practice (GLP)
Date: 22 April 2020
readThe Good Laboratory Practice (GLP) is a quality assurance system that deals with the organizational process and the framework under which non-clinical health and environmental safety tests are planned, carried out, as well as with the recording, archiving and reporting of the studies. However, GLP does not aim to make a statement about the scientific quality of a study.
The following GLP goals shall be achieved:
- Traceability of examinations through complete documentation
- Definition of responsibilities
- Clear organizational regulations
- Generation of data of adequate quality for the evaluation of a product
- International mutual recognition of data
Avoidance of multiple examinations
In order to maintain the quality assurance system, the 5 W method is used: Who has done what wherewith when why?
Everything that has not been documented formally is considered not to have been done.
As the GLP requirements are legal requirements, there are no self-certifications, but a government surveillance system with regular audits. SCC was officially re-certified as “GLP contract archive” at the last inspection 24th October 2018 by the “Landesamt für Umwelt Rheinland-Pfalz”. The legal foundations in Germany is “§19 of the German Chemicals Act” based on and the "Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004", based on the “OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring”, as well as the “OECD GLP consensus documents”.
Comparative assessment of plant protection products containing candidates for substitution
Date: 21 April 2020
readPlant protection products containing existing active substance(s) that are listed as candidates for substitution (see previous Academy Article), undergo a comparative assessment (CA) before a possible product authorisation or re-authorisation. This assessment is conducted by each concerned Member State (i.e. not the zonal Rapporteur Member State) at use level where an (re-)authorisation of the plant protection is requested.
The concept of comparative assessment is detailed in SANCO/11507/2013, as well as EPPO standard PP 1/271 and includes, but is not limited to, the evaluation/assessment of chemical or non-chemical alternatives, regarding
- their efficacy
- their risk of developing resistance, including the availability of chemical alternatives with several mode of actions
- their effects on minor uses and the availability of products for minor uses
- the exposure of different population subgroups (e.g. workers, …, consumers)
- their long term effects on organisms living in soil or an aquatic environment and
- the practical and economic feasibility.
Candidates for substitution
Date: 20 April 2020
readIn its endeavor to push industry towards “safer” active substances (a.s.) and products in plant protection, the authorities introduced in Article 24 of Regulation (EU) 1107/2009 the concept of Candidate for Substitution (CfS), meaning that “less safe” a.s. are substituted by “safer” ones. One consequence already felt at a.s. level, is the limitation of the approval period for a.s. classified as CfS to no longer than seven years.
The criteria for candidates of substitution are laid down in Annex II of Regulation (EU) 1007/2009 under point 4 and are – briefly summarized – as follows:
- ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances
- Two of the criteria to be considered as a PBT (persistent / bioaccumulating / toxic) substance are met
- There are reasons for concern linked to the nature of the critical effects which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern, for example, high potential of risk to groundwater; even with very restrictive risk management measures
- Significant proportion of non-active isomers
- Classification as carcinogen category 1A or 1B according to Regulation (EC) No 1272/2008
- Classification as toxic for reproduction category 1A or 1B, according to Regulation (EC) No 1272/2008
- The active substance is considered to have endocrine disrupting properties that may cause adverse effects in humans.
This concept is strictly limited to a.s., but the consequences are to be borne by the respective products containing a CfS a.s.
Date: 17 April 2020
readWhen a plant protection product (PPP) must be (re-) authorised and the PPP-applicant was not an applicant in the AIR procedure of the active substance, data matching is required, i.e. the PPP-applicant must “show access” (see below) to Annex I (KCA) data of the active substance (a.s.).
To show access to the Annex I data, there are different options:
1) Argumentation why data are not required
2) Referring to non-protected existing data
3) Letter of Access to the study /studies
4) Repeating the study / studies (vertebrate studies are special and must not be repeated)
Although the data matching is necessary for the product (re)-authorisation, the assessment of data matching is to be done by the Rapporteur Member State (RMS) of the active substance. The foreseen deadline for the assessment of the data matching is ideally within a month.
For new products (Article 33 applications; see Academy Article “Zonal approach”), the data matching has to be submitted with the application for authorisation.
In case of product re-authorisations (Article 43), specific deadlines are to be considered. The first step is to be done within 2 months following the publication of the EFSA-conclusion (a.s. AIR procedure). Here an indicative "data matching list" (see SANTE/2016/11449) is to be submitted to the RMS. The studies (or argumentation etc. as outlined above) must be submitted in a second step, within three months from the renewal of the approval of the active substance. Only under specific circumstances (e.g. change of the EU endpoints), it may be possible that some missing data matching studies could be justified as category 4 data (see Article “Category 4 studies”).
Efficacy requirements for new active substances (NAS)
Date: 16 April 2020
readEfficacy questions are of special relevance for each agrochemical, but the detailed focus here is on the authorization process of the plant protection products themselves and less on the approval process of the new active substances contained in the respective plant protections products. Accordingly, it is important to make a distinction between efficacy of an active substance at the approval stage and efficacy of plant protection products containing that active substance at the authorization stage.
Nevertheless, efficacy aspects like data on application and efficacy, function of an active substance (e.g. as herbicide or fungicide), its effects on harmful organisms or information on the occurrence or possible occurrence the development of resistance and appropriate management strategies have to be addressed in the data package to be submitted for the approval process. Such basic efficacy data requirements are laid down in COMMISSION REGULATION (EU) No 283/2013 of 1 March 2013.
A more precise description of the efficacy data requirements for the approval of new active substances is given in Guidance Document SANCO/10054/2013, stating that the main objective of the efficacy evaluation of an active substance is to confirm that the doses are realistic for the GAP submitted for risk evaluation at active substance approval but also representative for all subsequent product authorisations.
In order to address the efficacy of a new active substance on harmful organisms test results have to be submitted to demonstrate the effectiveness of this substance against at least one of the target species for which product authorisation will be sought in a range of crop species. Data should be supplemented by the results of realistic field trials from at least one year in at least one crop, and on at least one of the target species using a representative formulation of the new active substance, confirming that the proposed GAP is based on realistic practical conditions.
Besides testing at the proposed target dose, additional information on a range of doses above and below may be useful in order to confirm that the target dose is indeed sufficiently effective. Furthermore, test data shall confirm that there are no unacceptable effects on crops or accordant products.
In comparison to the authorization process of a plant protection product there is no requirement to submit a Biological Assessment Dossier (BAD) or individual trials reports as part of the approval of an active substance. Nevertheless, a concise summary of the effectiveness against named targets, representative of proposed uses at the proposed dose(s) and crop safety at the proposed dose(s) should be provided. It may also be useful to include a compilation of results at lower doses. The concise summary should also include a brief synopsis of any preliminary screening data which establishes the range of targets of the active substance.
Article 43 – Renewal of authorisation
Date: 15 April 2020
readArticle 43 is the re-authorisation of plant protection products and necessary after the active substance is renewed (Annex I renewal). To differentiate it from the a.s. (re-) approval we refer to it as (re-) authorisation.
For this approach strict deadlines apply:
With the application a dossier (dRR) must be submitted if no Category 4 studies are requested (see academy Article “Category 4 studies”). In the dossier new product data should be indicated (required as a result of new data requirements, new or changed endpoints/ criteria or necessary to amend original conditions of approval). The assessment shall be coordinated by the zRMS.
For products containing more than one active substance, specific approaches for submission and dossier preparation apply, depending on the time frame between the a.s. expiry dates. A detailed guidance can be found in the SANCO/2010/13170.
Zonal approach – How it works
Date: 14 April 2020
readAs mentioned in one of our previous Online Academy posts, the placing of plant protection product (PPP) on the market is a two-step approach in Europe. Once, the first barrier has been taken and your active substance (a.s) is approved, products containing this a.s. have to be authorized in each member state (MS), before “placing on market” is allowed. This latter procedure is described in detail in the Zonal Approach, referred in Articles 28 to 57 of REGULATION (EC) No 1107/2009, as well as the corresponding guidance document of the Commission Services (SANCO/13169/2010).
All MS are grouped in one of three political zones – the Northern (NEZ), the Central (CEZ) and the Southern (SEZ) Zone. When an application for a PPP is submitted, one MS in each zone is chosen to conduct the assessment as zonal Rapporteur Member State (zonal RMS). The other concerned MS (cMS) in the same zone to which an application has been submitted “shall refrain from proceeding to avoid duplication of work”, unless zonal RMS requests for their cooperation “to ensure a fair division of the workload”. In case an application for authorization is submitted to more than one zone, the zonal RMS in the different zones have to come to an agreement as to which MS will evaluate the data which are not related to the environmental and agricultural conditions within in the different zones.
Nevertheless, during the assessment, the zonal RMS shall give all MS in the same zone the opportunity to submit comments for consideration in the assessment. For the assessment itself, the Uniform Principles, described in REGULATION (EC) No. 546/2011 apply and the zonal RMS shall decide within twelve month of receiving the application, whether the requirements for authorization are met. A maximum extension period of 6 months is granted in cases where additional data are requested by the zonal RMS and shall cease at the moment when this additional information is received. Once the zonal RMS has concluded its assessment, it shall make available the conclusion in form of an assessment report to the other MS of the zone. On this basis the cMS shall grant or refuse an authorization at the latest within 120 days of receipt of the assessment report and the copy of the authorization of the zonal RMS.
When this authorization is granted, the second and final barrier has been taken and your product can be placed on the market. There are special rules and timeframes according to the re-authorization process which apply under Article 43 of REGULATION (EC) No 1107/2009. In cases of indoor and seed treatment uses the zonal concept is not applicable and an application can be evaluated by the zonal RMS on behalf of all EU-MS.
Electronic submission of dossiers – CADDY-xml format
Date: 13 April 2020
readIn the “old days” of Regulatory Affairs, we used to ship truckloads (literally!) of paper dossiers to the authorities. Luckily, this has changed and we use CADDY.
CADDY (Computer Aided Dossier and Data Supply) which is an electronic format for the exchange and archiving of complex dossiers, developed jointly by industry and regulatory authorities. It is intended for the interchange of active substance and plant protection product dossiers, and is currently used by the European Commission and Member States as the only electronic dossier interchange format.
Since 1st of February 2014, the use of the CADDY-xml format is mandatory for the submission of plant protection product dossiers to the German authority (BVL). Other European authorities highly recommend using this electronic format. The CADDY-xml format is used for the preparation of new active substance dossiers (CA + CP), Annex I renewal (CA + CP) dossiers and product dossiers in dRR (draft Registration Report) format.
CADDY-xml is the optimised version of CADDY 2.0 format, and introduces some important differences by providing the general information, a table of contents, confidential and non-confidential documents and report information in an XML overview. The initial CADDY-xml Specification has been finalised in June 2005 and agreed in the Joint Caddy Steering Group.
The CADDY-xml Converter is the only authorised programme to convert CADDY 2.0 dossiers to the new standard CADDY-xml.
CADDY 2.0 is based on TIFF-files which are replaced in CADDY-xml by PDF and Word versions of the documents. Additionally, a CADDY-xml dossier can be viewed with a common web-browser supported by Acrobat Reader. It is flexible enough to accommodate different dossier structures or standard Tables of Content such as OECD, EU or others.
GHSTS - The Global Harmonised Submission Transport Standard is considered as candidate to replace the current version of CADDY. Detailed information for GHSTS is announced for the summer of 2020.
EU voting procedure
Date: 10 April 2020
readThe Commission can implement EU legislation with the assistance of committees composed of representatives from EU countries. The committee members are national experts who represent EU member states and public authorities. By this so called Comitology, EU member states can influence how the European Commission implements EU laws.
In Comitology, two procedures are used for the adoption of implementing measures by the Commission: the examination procedure (used especially for (i) measures with general scope and (ii) measures with a potentially important impact (e.g. in taxation or EU agricultural policy)) and the advisory procedure (generally used for all other implementing measures). Based on the procedure, the impact of the committee's opinion on the Commission varies:
- Examination procedure
- Qualified majority in favour of the Commission's proposed measure (positive opinion): The Commission is bound to go through with this measure.
- Qualified majority against the Commission's proposed measure (negative opinion): The Commission cannot carry out the measure it proposed.
- No qualified majority for or against the Commission's proposed measure (absence of opinion): The Commission can choose either to carry out the proposed implementing measure or submit a new version of it to the committee, taking into account the views expressed in the committee.
- Advisory procedure – the Commission is free to decide whether or not to carry out the proposed measure, but must "take the utmost account" of the committee's opinion before deciding.
Particularly relevant for plant protection is the Standing Committee on Plants, Animals, Food and Feed (called ‘SCoPAFF’ or ‘PAFF Committee’). This committee provides for example opinions on adoption of new guidelines, but also the approval or non-approval of active substances is voted by the SCoPAFF via examination procedure.
Further information on Comitology can be found here.
Date: 9 April 2020
readBiorationals are not a regulatory defined category in EU, similar to biopesticides for example. Rather, in accordance with the definition of the American Society for Testing and Materials (ASTM) the term biorational is often used to describe a “broad range of low environmental risk substances and products that are typically biologically-derived or, if synthetic, structurally similar and functionally identical to a biologically occurring material”. Thus, biorationals include biopesticides as well as non-pesticidal substances and products such as biostimulants.
Whereat in EU, the term biopesticide has no regulatory definition, since entry into force of REGULATION (EU) No 2019/1009, for biostimulants an EU harmonised definition exists. According to this new regulation, biostimulants in the EU regulatory framework are defined as “an EU fertilising product, the function of which is to stimulate plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: (a) nutrient use efficiency, (b) tolerance to abiotic stress, (c) quality traits, or (d) availability of confined nutrients in the soil or rhizosphere”.
Contrary to non-EU regulatory frameworks such as, for example, in the US, the EU Plant Protection Products REGULATION (EC) No 1107/2009 does not define biopesticides as a specific substance or product category or class. In fact, the EU Plant Protection Product Regulation differentiates between basic substances, low risk substances and conventional substances and products irrespective of their biological, mineral or chemical origin.
Date: 8 April 2020
readAs you can already see from our previous posts, Annex-I-Renewal is a never-ending story. Active substances are (re)approved (“included into Annex I”) only for a limited period of time; where after they have to be reassessed. One interesting difference between (first) approval and re-approval concerns this approval time: while normal a.s. (i.e. those not being Candidates for Substitution or Low Risk Active Substances) are (first) approved for 10 years, their re-approval is normally issued for 15 years.
Although the fact of renewal will remain, we can at least change the expression which is no longer adequate: AIR-5 no longer mentions any “Annex-I”, but is officially called “The 5th renewal programme” – but everyone will understand what you say, if you mention AIR-5. It calls upon 65 a.s. with expiry dates between 1 January 2022 and 31 December 2024 (Commission Implementing Decision C/2018/3434). In this case, a.s. with similar properties are grouped together. As before, those that “may fail to satisfy the approval criteria” and – unlike before - those that are listed as candidates for substitution will be prioritised and these assessments “shall be carried out without delay or with as little delay as possible”, i.e. without extension of the expiry date of the a.s.
And finally, due to the similarities in their respective properties, the following a.s. are grouped and their expiry dates are amended accordingly (SANTE-2018- 10048):
(i) fluxapyroxad, bixafen, sedaxane, penflufen and penthiopyrad;
(ii) disodium phosphonates and potassium phosphonates;
(iii) eugenol, geraniol and thymol;
(iv) Trichoderma atroviride (strain I 1237) and Trichoderma asperellum (strain T34);
(v) benzovindiflupyr and isopyrazam.
As for all renewal endeavours, the applicant must submit an application to be granted an extension of the expiry date of the a.s. (SANTE-2019-13022).
And the 6th renewal programme? Is being discussed and the EU Commission has started its work. It will call upon a.s. expiring from 2025 to 2028 and the allocation of Rapporteur Member States is currently ongoing. It will take into account issues such as the latest amendments to the General Food Law, i.e. access to study reports.
Annex-I-renewal fourth stage – AIR-4
Date: 7 April 2020
readWith AIR-4 the authorities introduced a new concept into the renewal of approval of a.s. Just as for AIR-3 (see previous Academy Article), the 213 a.s. of AIR-4 are subdivided into groups and batches. And just like AIR-3, groups 1 and 4 are grouped by the expiry dates of the respective a.s. But unlike AIR-1, AIR-2 and AIR-3 groups 2 and 3 differ from this criterion. Group 2 calls on a.s. which are “presumably low-risk substances” and Group 3 contains the a.s. that “may fail to satisfy the approval criteria”. And, while for groups 1 and 4 an extension of the a.s. expiry date is handled under the same prerequisites as for AIR-3, i.e. availability of an application (SANTE-2016-11734), the approval expiry dates for a.s. in groups 2 and 3 are only reluctantly extended, if at all (SANTE-2016-10616).
AIR-4 calls upon a.s. with approval expiry dates between 1 January 2019 and 31 December 2021 (Commission Implementing Decision 2016/C 357/05). The expiry dates of a.s. in AIR-4.4.1 (AIR-4 Group 4 Batch 1) have already been postponed for 2 years and those of AIR-4.4.2 by 3 years.
Under AIR-4 some dossiers have been submitted and are under evaluation by the authorities. Again the Rapporteur Member States cannot be chosen by the applicant, but are assigned (REGULATION (EU) No 2016/183).
Annex-I-renewal third stage – AIR-3
Date: 6 April 2020
readAs you have heard in previous postings, the Annex-I-inclusion of an active substance (a.s.), is granted only for a limited time period. Thereafter, it needs to be renewed. This is done in individual stages and today, as AIR-1 and AIR-2 are – in principle – completed, we will be looking at AIR-3. Starting with AIR-3, the regulatory and legal stipulations are provided in COMMISSION IMPLEMENTING REGULATION (EU) No 844/2012. Unlike AIR-1 (7 a.s.) and AIR-2 (31 a.s. of which 29 were originally defended), AIR-3 called up 150 a.s. with expiry dates between 31.01.2013 to 31.12.2018 of which 136 a.s. were originally defended by applicants. Due to the large number and the amount of work associated, AIR-3 was separated into 4 Groups consisting in turn of individual batches, which had the same submission dates (SANCO/2012/11284). The only criteria for the grouping were the original expiry dates of the a.s.
For Annex-I-renewals, the applicant is not free to choose his Rapporteur Member State (RMS), but each a.s. is assigned to a specific Member State (REGULATION (EU) No 686/2012). The assessments across AIR-3 a.s. are currently in all stages of the process: preparation of the Renewal-Assessment-Report, EFSA conclusion, Renewal Report and Amending regulation – and there are delays for each of the evaluation stages. A very significant proportion of the evaluations under review in AIR-3 are still pending.
If there is an extension of the submission deadline for the dossier (and in most cases up to now there was!), only those a.s. are eligible, for which an application was submitted. The received applications are listed in SANCO/10148/2014. As the time for evaluation is not affected by these extensions, the expiry date of the approval of the respective a.s. is also postponed.
AIR procedure – when, how and why you have to apply for a renewal of approval of active substances (REGULATION (EU) No 844/2012)
Date: 3 April 2020
readThe AIR procedure or AIR programmes describe the renewal of approval of active substances used in plant protection products. The first AIR programme was initiated in 2007 and covers substances listed in Annex 1 of Directive 91/414/EEC, hence the name Annex 1 Renewal (AIR). The subsequent renewal programmes are also named ‘AIR’ and a consecutive number, e.g. AIR-2, AIR-3 is added to separate the different programs from each other. Currently, 4 programmes have been initiated, and a 5th program, covering substances that expire between January, 1st 2022 and December, 31st 2024 is already established. Implementation of an AIR-6 program is envisioned and under preparation.
New active substances (NAS) and existing active substances (EAS) under Directive 91/414/EEC and REGULATION (EC) No 1107/2209
Date: 2 April 2020
readUnder former Directive 91/414/EEC a new active substance (NAS) is defined as a substance with market entry after July 1993, whereas an existing active substance (EAS) defines active substances with market entry before July 1993, i.e. 2 years after publication of Directive 91/414/EEC. In order to bring all existing active substances on the European market to the same standard, the commission initiated a work programme with Directive 91/414/EEC for the gradual examination of all currently approved substances. This programme ran from 1995 until 2012 and included 4 separate lists and stages:
- List 1: 1st stage REGULATION (EEC) No 3600/92
- List 2: 2nd stage REGULATION (EC ) No 451/2000
- List 3: 3rd stage REGULATION (EC ) No 1490/2002
- List 4: 4th stage REGULATION (EC) No 2229/2004
Main aspects taken into account during the examination include health and environmental concerns, the possibility of residues in treated products, and information on knowledge gaps in documents of existing active substances.
Under the ‘new’ REGULATION (EC) No 1107/2009, new active substances per definition have not yet been approved for use in plant protection products and the applicant can choose the RMS (Rapporteur Member State). In contrast to that, existing active substances have already been approved previously and the RMS/Co-RMS is allocated. The procedure for the renewal of approval of existing active substances is summarized in the AIR (Annex-I-renewal) programmes. If you want to learn more about the AIR programmes, stay tuned for a new contribution to our temporary online academy.
REGULATION (EC) No 1107/2009
Date: 1 April 2020
REGULATION (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC – and a little bit of (necessary) history
This is the foundation of plant protection legislation in Europe today – but we usually go by calling it “1107”.
It is the legislation successive to Directive 91/414, which was replaced by our “1107”, when the latter became applicable on 14 June 2011. Nevertheless “91/414” has significantly shaped the landscape of active substances (a.s.) in Europe. It called for a review of all existing a.s. in the EU and organised them into 4 individual stages, also called lists, with successive deadline for submission of dossiers. List 1 contained the a.s. of highest concern and list 4 those of (mostly) natural origin. When, after the assessment, an a.s. was found suitable, it was “included into Annex I” and could remain on the market for 10 years (usually), before it had to be re-assessed.
The purpose of “1107” is laid down in Article 1.3: “… to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production.” And its scope is stipulated in Article 2 – which is currently undergoing some changes with the advent of the new Fertiliser Regulation.
REGULATION (EC) No 1107/2009 is separated into individual chapters and 3 Annexes. And, while the Regulation is important in its entirety, the main provisions for the regulatory procedures and data requirements are laid down in Chapter 2 ACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS (Articles 3 to 27) and Chapter 3 PLANT PROTECTION PRODUCTS (Articles 28 to 57), indicating that the process for keeping Plant Protection Products (PPP) in the market is a two stage process, a.s. first and then PPPs.
Of course, “1107” has provisions for the evaluation of new active substances as well as existing active substances, the latter is called still Annex-I-Renewal (AIR), although today we speak with “1107” of approval and not of any “Annex I inclusion”. And this is why we undertook this short excursion into the history of plant protection regulation in the EU.