ECHA introduces changes to the compliance check process as of 1 January 2019

Date: 19 December 2018


In the course of the 27th Meeting of Competent Authorities for REACH and CLP (CARACAL) ECHA published a document (CA/63/2018) concerning the changed dossier evaluation and compliance check on 12 June 2018. The introduced changes will be effective from 1 January 2019.

In case you are planning to update your REACH dossiers we can provide you with support. Please get into contact with This email address is being protected from spambots. You need JavaScript enabled to view it..


Essential aspects of the 2nd REACH review from the point of view of the BMU

Date: 19 December 2018


On 6-7 December 2018 the BAuA REACH congress 2018 took place in Dortmund. In the introductory presentation, Dr Axel Vorwerk, ministerial official at the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety in Germany (BMU*), outlined the essential aspects of the 2nd REACH review from the point of view of the BMU.

*Federal Ministry for the Environment, Nature Conservation and Nuclear Safety in Germany (BMU)


New SCC Service on eSDS: Translations into all European Languages implemented

Date: 18 December 2018

When a risk assessment according to REACH Article 14 or 37 has been conducted for a registered substance, the corresponding exposure scenarios as well as risk management measures (RMMs) have to be communicated to the downstream users (DU) by providing an extended Safety Data Sheet (eSDS; REACH Art. 31 (7)). This eSDS must be made available in the respective official language of the member state in which the substance is marketed (REACH Art. 31 (5)). Thus, translating eSDS is a crucial step for Registrants in order to fulfil their duties under REACH. In the past no tool was available providing an automatic translation of the Annex to an eSDS containing the exposure scenarios.
With Chesar, one of the most widely used tools for risk assessments, an eSDS can be easily prepared for a substance – however, only in English.
SCC has now implemented a new service that allows translations of eSDS into all European languages with Chesar. The only prerequisites for this service are:

  • A risk assessment for the corresponding substance in Chesar is available
  • Harmonized phrases according to ESCom are applied to describe uses and their RMMs

Of course, both of the above are well-established services of SCC as well.
Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. or your direct SCC partner to learn how easily you may get ready with your eSDS translations.


Improving the workability and quality of extended Safety Data Sheets

Date: 18 December 2018

In the course of the recent meeting of the competent authorities for REACH and CLP (CARACAL) the member states, the Commission, ECHA and stakeholders discussed how to improve the workability and quality of extended Safety Data Sheets.
The Safety Data Sheet is a mandatory tool for suppliers of hazardous chemicals (substances and mixtures) to provide the users with safety-relevant information. For substances that require a Chemical Safety Report to accompany the registration dossier, the corresponding Exposure Scenarios (ESs) extend the traditional Safety Data Sheet (SDS) to an extended SDS (eSDS), with information on use- or task-specific conditions of safe use.
ECHA has identified a number of root causes that affect the workability and quality of the extended safety data sheet.



Composition or formulation type changes of PPP: Release of EPPO Standard PP 1/307(1)

Date: 19 November 2018

For the first time EPPO (European and Mediterranean Plant Protection Organization) releases a detailed guidance about data requirements and data generation in case of changes of the chemical composition or the formulation type of plant protection product. With Standard PP 1/307 (1) Efficacy considerations and data generation when making changes to the chemical composition or formulation type of plant protection products,  any applicant considering a composition change receives an essential tool which helps hem to decide whether the provision of accordant biological data (efficacy and selectivity) might be required or not and which necessary steps are to be taken in case of a significant composition change. The new EPPO Standard also specifies the requirements for the development of a new product. These requirements are to be based on the principle of comparing with, and ‘bridging’ to, an existing formulation, which for its part should be supported by a full data package.

Please contact This email address is being protected from spambots. You need JavaScript enabled to view it., head of the efficacy group at SCC, in case of any questions concerning the data requirements related to composition changes of plant protection products.


Development of co-formulated mixtures: Release of new General EPPO Standard PP1/306(1)

Date: 16 November 2018

With the new Standard PP 1/306 (1) about the General Principles for the development of co-formulated mixtures of Plant Protection Products,  the European and Mediterranean Plant Protection Organization (EPPO) releases a detailed guidance for the needed and requested efficacy justifications when using mixtures, considering their potential advantages and disadvantages. The new EPPO document primarily examines the appropriateness of such mixtures in terms of resistance management, which is getting more and more important for the registration of plant protection products.
Co-formulated mixtures are defined as plant protection products containing more than one active substance. This includes the mixing of different pesticide types, e.g. fungicide plus insecticide, and also considers the mixture of e.g. fungicides with plant growth regulators. Although the new Standard does not specifically address mixtures with safeners or synergists, the general principles may be of relevance for them as well. The new Standard does not consider, however, the provision of individual active substances in separate containers in a common product package (the so-called ‘combi- or twin-packs’).
Applicants are required to explain and substantially demonstrate in their submissions the rationale for, and the specific benefits of a proposed mixture product, taking into consideration the fact that the evidence needed for the authorisation support will vary, depending upon the rationale for the mixture.

Please contact This email address is being protected from spambots. You need JavaScript enabled to view it., head of the efficacy group at SCC, if you would like any kind of support related to the development of co-formulated mixtures of plant protection products.


Regulation concerning evaluation of ED criteria in the renewal procedure for a.s. under Regulation (EC) 1107/2009 including pending applications

Date: 9 November 2018

On 7 November 2018, the Commission released Regulation (EU) 2018/1659 amending Regulation (EU) 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties. Those criteria are to apply as of 10 November 2018 to applications for the renewal of the approval of active substances, including pending applications.

In addition, the Commission adopted an official communication outlining its strategy for the protection of citizens and the environment from all hazardous chemicals.


Biopesticide and biostimulant growth prompts need for registration

Date: 5 November 2018 (see our original news dated 10 August 2018)

Dr Lars Huber's interview on recent developments in the biostimulants market for the 2018 Biologicals Special, which we earlier gave account of in Current News, is now available in Chinese as well.


UK releases guidance on chemicals regulation in case of ‘no-deal’ Brexit

Date: 17 October 2018

In view of the approaching Brexit in March 2019 the United Kingdom published in October 2018 technical notices as guidance in case UK leaves the EU without an agreement (‘no deal’ scenario). Although negotiations with the EU are ongoing, UK intends to ensure therewith to be prepared for all eventualities from day 1 after Brexit.

These published technical notices cover the following topics:


Approval of new General PP1 Efficacy Standards by EPPO Council

Date: 9 October 2018

In its last session in Paris on 25 and 26 September 2018, the EPPO council approved among others two draft PP1 General Standards which are of particular interest for the plant protection industry. The new General Standard defining the General Principles for the development and registration of co-formulated mixtures of Plant Protection Products will provide detailed guidance for the needed and requested efficacy justifications and testing requirements for co-formulated mixtures, considering their potential advantages and disadvantages. A further main focus of this document will be on the examination of the appropriateness of such mixtures in terms of resistance management, which is taking on an added importance for the registration of plant protection products.
In the second new General Standard Efficacy considerations and data generation when making changes to the chemical composition or formulation type of plant protection products, EPPO will for the first time release a detailed guidance about data requirements and data generation in case of changes of the chemical composition or the formulation type of plant protection products. With this Standard any applicant thinking about a composition change will receive an essential tool whether the provision of accordant biological data (efficacy and selectivity) might be required or not and which necessary steps to take into account, if a significant composition change is intended. The establishment of General Standards by EPPO is a lengthy process: Both new standards were already discussed among authority and industry experts at the EPPO Workshop held in Sofia in October 2013. The new standards are of importance for future efficacy trial programs and should in particular be considered for bridging trials and the testing of new mixture products. SCC will provide a detailed analysis after official publication of the documents on the EPPO homepage, which is expected soon (see https://pp1.eppo.int/). The Standards will also be published in the EPPO Bulletin.

Implications of Brexit for fertilisers

Date: 27 September 2018

On Sep 25th the European Commission published a new notice to stakeholders on the withdrawal of the United Kingdom and EU rules in the field of fertilisers.

In general, the EU rules for EC fertilisers, that is Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers, will no longer apply in the United Kingdom after Brexit which will affect imports and exports of fertilisers in various ways. In regards to the responsibilities for importers of fertilisers, the notice to stakeholders highlights that due to this, ‘a manufacturer established in the United Kingdom will no longer be an economic operator established in the EU [as required for EC fertilisers]. As a consequence, an economic operator established in the EU-27 and placing EC fertilisers coming from the United Kingdom on the EU-27 market, until then considered as a distributor, will become an EU importer in relation to such products. This operator will therefore have to comply with the respective obligations for manufacturers’.

Further information and updates are available on the EU Commission website.


International Code of Conduct for the use and management of Fertilisers is released

Date: 24 August 2018

The FAO and the Intergovernmental Technical Panel on Soils (ITPS) released a zero-draft of an „International Code of Conduct for the Use and Management of Fertilizers“. This document highlights the need of fertilisers in modern agriculture but mentions also the adverse effects if fertilisers are not used according to Good Agriculture Practice. The code of conduct helps to keep a global perspective in mind, since fertilisers are regulated under several national legislations.


Dr Carla Lorenz, Agrochemicals and Biopesticides - Biostimulants, Fertiliser, IPM


 

SCC establishes SCC Japan K.K.

Date: 15 August 2018

For 11 years, SCC has been running a Liaison Office Japan to support our Japanese customers in registration of their active substances and products in the EU. The increasing interest of our Japanese and European customers in international registration services in recent years was decisive for us to take the next key step – the establishment of SCC Japan K.K., which we officially founded on 30 July 2018.
SCC Japan K.K. provides the perfect basis for us to further promote cooperation with our Japanese customers by offering scientific and regulatory services in Japan. We also actively support our customers in all registration issues in line with European and international regulations.
In Japan, we offer regulatory support in accordance with Chemical Substance Control Law (CSCL) and Industrial Safety and Health Law (IHSL). In addition, we are currently rounding out our services portfolio for the Japanese market by elaborating our expertise in registration of plant protection and biocides products.

We look forward to guiding your products to successful registration, be it in Europe, Asia-Pacific or Americas. The establishment of SCC Japan is a significant contribution to our business development. For further questions on international markets, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

We will keep you updated on further developments of our services in Japan and international markets.


Biopesticide and biostimulant growth prompts need for registration

Date: 10 August 2018

While the global biorational market is booming and regulation agencies are taking pains to keep the pace, the significance of choosing the right registration strategy becomes even more evident.

Lars Huber, Head of Biostmulants, Fertiliser, IPM, shares in the interview for the Biologicals Special his considerations on recent developments in the biostimulants market, SCC's expertise in the field as well as what you need for a successful product registration.
To read the full article, please click here.

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM


Brexit implementation period and the Chemicals sector

Date: 13 July 2018

UK Health and Safety Executive (HSE) has recently published important information regarding the BREXIT implementation period and the chemicals sector.
During the implementation period the UK will no longer be a Member State of the European Union, but UK-EU trade will be able to continue on the same terms as now up until the end of 2020.


Guidance on how to identify substances with endocrine disrupting properties in pesticides and biocides

Date: 12 July 2018

The European Commission tasked EFSA and ECHA with developing harmonised guidance to ensure that the endocrine disruptor criteria adopted by the EU in 2017 are applied consistently for the assessment of biocides and pesticides in the EU.
The “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 Pre-publication version” was drafted with the support of the Joint Research Centre and published in June 2018.
It aims to assist in complying with obligations under the Biocidal Products Regulation (BPR). With regard to the Plant Protection Products Regulation (PPPR), it will be used in the assessments of all active substances for which a decision is scheduled on or after 10 November 2018*.

For more information, please contactThis email address is being protected from spambots. You need JavaScript enabled to view it., Vice President / Head of Regulatory Science, Pharma Pre-Clinical.


Efficacy of low-risk substances and micro-organisms

by Dr. Lars Huber and Dr. Joachim Kranz in Agrow's annual biologicals 2018 review
Date: 01 July 2018

In the article, both scientists put under scrutiny the new standard of the European and Mediterranean Plant Protection Organization (EPPO) on the "Principles of efficacy evaluation for low-risk plant protection products", PP1/296(1). They critically examine the key aspects and implementation possibilities of the new EPPO's standard as well as its impact on the regulatory framework in general and product authorisation specifically. To read the whole article, please click here.

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM

Dr Joachim Kranz, Manager Regulatory Affairs, Agrochenicals and Biopesticides - Efficacy


New regulation on Europe’s organic agriculture published

Date: 18 June 2018

The new Regulation 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation No 834/2007 was published on 15 June 2018 (see also SCCs Current News of 24 April 2018).
The new Regulation, which applies from 1 January 2021, sets out the legislative framework for Europe’s organic agriculture. Based on this basic act, further legislation such as implementing regulation will have to follow-up in the near to mid future.

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM


New publication on biopesticides: Guidance document for the assessment of the equivalence of technical grade active ingredients for identical microbial strains and isolates

Date: 30 May 2018

A new guidance document dealing with the assessment of technical equivalence of microorganisms used in microbial pesticides was developed in the framework of the OECD Expert Group on BioPesticides (EGBP) and published in the OECD Environment, Health and Safety Publications Series on Pesticides, No. 96 on 22. May 2018.
The document aims to provide guidance to PPP industry and regulatory authorities by harmonising the methods and approaches for the assessment of biological pesticides. It gives background information, describes the procedure for the assessment of the equivalence of new sources of technical materials, explains terms and definitions and provides a template for an evaluation report on the equivalence for microorganisms. The evaluation report comprises Section A - Identity of the microorganism and Section B - Analytical methods as well as overall conclusions on the equivalence.

Beate Tschoepe, Agrochemicals and Biopesticides - Biostimulants, Fertiliser, IPM


New regulation augurs improved mutual recognition for fertiliser and biostimulant products

Date: 28 May 2018

Currently, the regulatory basis for mutual recognition (MR) of non-harmonised fertiliser and certain biostimulant products is Regulation 764/2008 and the respective MR guidance for fertilisers and growing media. REFIT of the EU fertiliser regulatory framework including Regulation 2003/2003 on (inorganic) fertilisers has shown that the EU market for fertilisers, growing media and biostimulants not covered by Regulation 2003/2003 suffers from non-harmonisation of these products (e.g. COM(2016) 157 final). To counter this, a EU Regulation covering also e.g. organic fertilisers and biostimulants is currently under preparation. 

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM


Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties

Date: 16 May 2018

The European Union is the first region and regulatory system worldwide to define scientific criteria for endocrine disruptors (EDs). Under EU’s Biocidal Products and Plant Protection Products Regulations (EU No 528/2012 (BPR) and EC No 1107/2009 (PPPR)), an active substance, which is considered as having ED potential will not be approved unless the risk from exposure is negligible (BPR), unless exposure is negligible (PPPR), or there is evidence that it is essential to prevent or control serious pests or it is required on socioeconomic grounds (BPR).

The ED-criteria for plant protection products (EC No 1107/2009) have been under scrutiny of the European Council and the European Parliament (EP). The initial regulation was rejected by the EP in October 2017. The new proposal taking into consideration the claims of the EP (the criteria contain no more the specific provision for the so-called “growth regulators”) was adopted by a narrow Qualified Majority during the Standing Committee on Plants, Animals, Food, and Feed (PAFF) meeting dated 12-13 December 2017. The final adoption by the Commission has been recently performed in April 2018. To read the whole article, please click here.

Article originally published in SCC Newsletter – EXTRA, May 2018


Release of guidance for dose expression for vertical crops in Belgium

Date: 14 May 2018

The Federal Public Service (FPS) Health, Food Chain Safety and Environment Service Plant protection products and Fertilizers recently released a new guidance document explaining how Belgium has been dealing in the past and will continue in future with dose expression for vertical crops. The guidance comes into force for all applications submitted in Belgium from 1 January 2019 onwards. Jasmin Philippi, Assistant Manager Regulatory Affairs, Agrochemicals and Biopesticides - Biostimulants, Fertiliser, IPM


New EU Code on agricultural data sharing

Date: 3 May 2018

The new “EU code of conduct on agricultural data sharing by contractual agreement” was signed on 23 April by the 9 agro-food chain organisations and associations CEETTAR, CEJA, CEMA, Copa and Cogeca, ECPA, EFFAB, ESA, FEFAC and Fertilizers Europe (see below).

In recent years, the rise of precision/digital farming systems led to a huge increase in agri-food chain data available to be processed, shared and analysed. Considering the current scientific and technical progress and the envisaged uses of precision/digital farming methods (e.g. CAP-reform), a further tremendous increase is to be expected in the years to come.

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM

Commission clarifies its position on registration obligations regarding cease of manufacturing before the 2018 deadline

Date: 27 April 2018

In SCC’s last newsletter we reported about the Commission’s position on phase-in status after May 2018 with a special focus on Commission’s interpretation of registration obligations.

On 4 April, the Commission provided a clarification on its statement. The intention of the statement was to confirm that, regardless of whether a manufacturer or importer of a phase-in substance ceases to manufacture or import after the deadline, he will have to register. This differs from the scenario described by the Germany CA which focuses more on the scenario before the registration deadline.

Dr Thomas Roth, Head of Chemicals/REACH, Consumer Products, Cosmetics, Feed & Food Additives

EPA Interim Science Policy for the Replacement of Animal Testing for Skin Sensitisation

Date: 27 April 2018

On 10 April 2018, EPA published a draft of an Interim Science Policy to reduce animal testing for skin sensitization, which can be found here. The draft of the Interim Science Policy is open for public comment until June 9, 2018.

The draft document states that the Office of Pesticide Programs (OPP) and Office of Pollution Prevention and Toxics (OPPT) will immediately begin to accept submissions as described in the draft Science Policy.

Dr Thomas Roth, Head of Chemicals/REACH, Consumer Products, Cosmetics, Feed & Food Additives

European Parliament adopts new regulation on Europe’s organic agriculture

Date: 24 April 2018

On April 19th European Parliament has adopted the new legislation on EU organic farming rules thus repealing Regulation 834/2007. The new regulation, initiated in 2014, was adopted with 466 votes against 124.

As the organic farming sector has hugely grown in the last years, organic managed farms covering 6.7 % of Europe’s agricultural area (2016, EU-28), the new Regulation tries to adapt the regulatory framework for organic farming to these new circumstances and establish the basis for the further growth of this farming sector.

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM

Commission publishes new rules on transparency and sustainability of the EU risk assessment in the food chain

Date: 24 April 2018

In April, Commission published its proposal for a new regulation to improve the transparency and sustainability of EU risk assessments for plant protection products, GMOs (cultivation, food/feed uses), feed additives, food contact materials, food additives, food enzymes and flavourings, novel foods and smoke flavourings (COM(2018) 179 final). The new Regulation is a follow-up of the fitness check of the General Food Law Regulation (Regulation 178/2002), initiated in 2014, and the Commission's reply to the European Citizens Initiative ‘Ban glyphosate and protect people and the environment from toxic pesticides’. Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM

ECHA’s news: Mastering challenging chemical risk assessments using Chesar

Date: 15 February 2018
Dr Thomas Roth, Head of Chemicals / REACH, Consumer Products, Cosmetics, Feed & Food Additives

Another warning notice to stakeholders issued by European Commission on 23 January 2018

Date: 25 January 2018
 
In this renewed warning, the EU Commission stated:

“Concerning submissions of new applications, business operators should take into account the expected timelines of different regulatory procedures in which the United Kingdom would be acting as, for example, rapporteur Member State, zonal rapporteur Member State or evaluating Member State for MRLs. Taking account of the aforementioned uncertainties as well as the regulatory framework, business operators should consider taking the relevant actions. For example, where there is a risk that those procedures are not concluded by the date when the United Kingdom will leave the Union, applicants may choose by preference another Member State to carry out the evaluation or assessment.

Concerning those on-going procedures for which the United Kingdom is currently carrying out an assessment or evaluation, business operators should carefully monitor their progress. Where there are clear indications that the procedure will not be concluded by the withdrawal date, taking account of the uncertainties as well as the regulatory framework, business operators should consider taking the necessary actions. For example, a change of rapporteur or evaluating Member State may be required.“ 


New head of Biocides business unit starting in January 2018

 

Martina Galler has a PhD in biology and more than 15 years of experience in biocides regulatory affairs. She currently heads up the preservatives group within SCC’s Biocides business unit and will take up her new role at the beginning of 2018. Martina’s field of expertise comprises all BPR activities relating to biocidal active substances and products as well as the environmental risk assessment of biocides in nearly all product types.