Low risk substances in the EU

by Dr Bernd Brielbeck in Agrow’s Latin America supplement 2017

Date: 31.07.2017

The article summarizes the current legislative situation of the low risk substances in the EU, focusing on today’s challenges and prospects ahead. To read the article, please click on the link.

Dr Bernd Brielbeck, Senior Manager Regulatory Affairs, Agrochemicals and Biopesticides

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New head of Chemicals business unit since July 2017

 

Thomas Roth has a PhD in food chemistry and is a certified expert for toxicology. He has been with SCC for more than 8 years now, leading the Toxicology group within the Regulatory Science business unit before taking the new responsibility this summer. Prior to joining SCC, Thomas Roth worked in the chemical industry for 10 years gaining his considerable professional experience in chemical toxicology and regulation.
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Moving towards simpler registration conditions for biostimulants in the EU?

A critical review on current development of biostimulants by Dr Lars Huber in Agrow's supplement Biologicals 2017

Date: 30.05.2017

To view the article, please follow the link.

 Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM _______________________________________________________________

Latest developments in efficacy assessment in agriculture

by Dr Norbert Weissmann

Date: 15 February 2017

Please follow this link to view Norbert’s report on efficacy assessment in agriculture as presented at the Crop and Chemicals Europe in Berlin in February 2017. It provides an overview of current regulatory developments in efficacy, focusing on efficacy testing in 3-dimensional crops, data requirements for re-formulated products and key factors for efficacy testing of biopesticides and biostimulants.  
For a brief summary of Norbert's presentation, please click here.

Dr Norbert Weissmann, Senior Manager Regulatory Affairs – Agrochemicals and Biopesticides, Head of Efficacy group
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Low risk substances: a comprehensive overview

by Dr Bernd Brielbeck

Date: 15 February 2017

Click here to download Bernd’s guidance on low risk substances as presented at the Crop and Chemicals Europe in Berlin in February 2017. This presentation offers you a comprehensive overview on regulatory and political framework of low risk substances, guidance documents, handling of low risk criteria, hands-on experience and the outlook in the future. To view the synospsis of Bernd's presentation, please follow this link.

Dr Bernd Brielbeck, Senior Manager Regulatory Affairs, Agrochemicals and Biopesticide
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Spotlight news: France undertakes steps to advance the development of biocontrol solutions

Date: 22 December 2016

On 3rd November 2016, the French authorities issued the official list of biocontrol products, introducing a number of benefits to promote further development of biocontrol solutions. This includes the exemption from certain bans applied to plant protection products.

Biocontrol products are not affected by the following bans:  
•    Ban on the use in amenity areas, forests, public roads, and walking paths accessible or opened to the public from 1st January 2017
•    Ban on direct sales in self-service to amateurs from 1st January 2017
•    Ban on placing on the market, delivery, use and holding for amateur use from 1st January 2019.
For more information, please view our newsletter Vol. 16, No. 5.

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Biopesticides and the EU regulatory process

Date: 30.05.2016

Do biopesticides exist in EU legislation? What makes the approval process of biopesticides different from that of other active substances?

SCC’s Senior Manager Lars Huber reflects on these and related issues in his article in Agrow Biologicals 2016. Interested? Please click here

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM

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Biopesticides market - a vision of  a promising future?

Date: 30.05.2016

Acceptance and market share growth of Biopesticides depend on a successful incorporation of all parties involved in the process chain, i.e. industry, manufactures and distributors, researchers, grower organisations as well as private and governmental crop protection services.  

Dr Lars Huber, Head of Bio-stimulants, Fertiliser, IPM, shares his professional expertise on the future prospects of Biopesticides market in his interview in AgroNews. Read more

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Hot topics in plant protection - interview with Bernd Brielbeck

Date:  February 2016

www.informa-ls.com/event/cropsandchemicals2016

 

 

Applicability of new data requirements to applications for authorisation of plant protection products

Date: 06.02.2015

SCC has learnt that the legal services of the European Commission informed Member State authorities that the current understanding of the applicability of the new data requirements for product authorisations cannot be upheld.

The interpretation of article 4 of COMMISSION REGULATION (EU) No 284/2013 that Regulation (EU) No 545/2011 (i.e. the old data requirements) continued to apply only, where the respective application for product authorisation is submitted prior to 31 December 2015. The Commission stipulates now that this condition only holds for plant protection product applications, containing an active substance for which a dossier or supplementary dossier has been submitted prior to 31 December 2013, as is stated in the second part of article 4 (i.e. AIR 2 a.s.).

If the condition on active substance dossier submission is not fulfilled (i.e. for all AIR 3 a.s.), COMMISSION REGULATION (EU) No 284/2013 (i.e. the new data requirements) applies for all applications for product authorisations submitted as of 1 January 2014!

Summarising the above, the old data requirements continue to apply, only to applications for authorisation of plant products containing at least one AIR 2 a.s. (alone or in mixtures), if the application is submitted prior to 1 January 2016. In all other cases the new data requirements must be observed.

The legal services of the Member States are currently examining the view of the Commission.

For more information, please contact Dr. Albrecht Heidemann at This email address is being protected from spambots. You need JavaScript enabled to view it.

 

 

Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009 (SANTE/2010/13170 rev. 13)

Date: 03.09.2015

The Guidance Document indicates the timelines in which the assessment is to be completed. Article 43 of the Regulation (EC) 1107/2009 provides that an application for the renewal of authorisation shall be made within 3 months from the date of entry into force of the decision on the renewal of the approval of an active substance. For products containing more than one active substance this step is to be done after the renewal of each active substance contained in the product. The assessment of the application by the Member State is to be done within 12 months after the renewal of approval of the active substance (Art. 43.5).

The application should include any new product data which are required due to new endpoints or criteria. The published Renewal Assessment Report is to be used to be aware of tests and studies. The EFSA conclusion shows where critical endpoints have been changed in the active substance renewal procedure.

Changes concerning authorised uses (e.g. amendment of the GAP) are only acceptable where it is necessary to comply with changes in the assessment of the active substance (e.g. new endpoints or restrictions). One exception is a non-significant formulation change according to SANCO/12638/2011.

Before the application, the so called “pre-notification-form” (as summarised in SANCO/12544/2014) is to be provided by the authorisation holder to the concerned Member State(s). A new outcome of this Guidance document is that the “pre-notification-form” should be submitted by the deadline for the submission of the supplementary dossier for the renewal of the active substance. An updated version should be submitted within 2 months following the publication of the EFSA-conclusion.

For the application to renew the authorisation, the EU PPP Application Management System is to be used. After every step in the procedure, it should be updated by the applicant or the concerned Member State.

For more information, please contact Dr. Albrecht Heidemann at This email address is being protected from spambots. You need JavaScript enabled to view it.

 

 

NEW EU LIST OF CANDIDATES FOR SUBSTITUTION

Date: 28.01.2015

PESTICIDES: EXPERTS ENDORSE NEW EU LIST OF CANDIDATES FOR SUBSTITUTION

A Commission proposal to establish an EU list of 77 candidates for substitution was endorsed on 27 January 2015 by EU Member State experts. Candidates for substitution (CfS) are pesticides for which national authorities need to carry out an assessment to establish whether more favorable alternatives to using the plant protection product exist, including non-chemical methods. The aim is to encourage more sustainable crop protection.

Please refer to http://europa.eu/rapid/press-release_MEMO-15-3743_en.htm for further information.

For more information, please contact Dr. Albrecht Heidemann at This email address is being protected from spambots. You need JavaScript enabled to view it.

 

News from Korea

Date: 20.08.2014

In Korea, the Act on Registration and Evaluation of Chemicals of Korea (also known as “K-REACH”) will come into force on 1 January 2015 and will from then on regulate the registration of chemicals.

 

‘AIR2’ ACTIVE SUBSTANCES – REQUEST OF MEMBER STATES FOR PRODUCT INFORMATION

Date: 07.08.2014

REQUEST FOR INFORMATION: PRODUCTS CONTAINING ‘AIR2’ ACTIVES TO BE SUPPORTED AT ARTICLE 43 RENEWAL.

Following renewal of approval for the ‘AIR2’ active substances (Reg. (EC) 1141/2010; http://eur-lex.europa.eu), the process of Article 43 (the renewal of authorisations for all products containing those active substances) will begin.

 

SCC: 25 years and beyond – Optimal service in a new design

13.06.2014

read more

Conditions of approval for three active neonicotinoids changed

28.05.2013
The European Commission has changed the conditions of approval for the active neonicotinoid substances Clothianidin, Thiamethoxam and Imidacloprid, and prohibits the use and sale of seeds treated with plant protection products containing those active substances. The Authority has based its decision on the risk assessments for bees for these three actives. Member States are to amend or withdraw existing authorizations for plant protection products containing these three active substances by 30 September 2013. Periods of grace will be as short as possible and will expire on 30 November 2013 at the latest. Commission Implementing Regulation (EU) No. 485/2013 can be read here in its entirety.

 

Chlorfenapyr (PT8) included in Annex I of BPD

28.05.2013
The European Commission has approved the inclusion of Chlorfenapyr in Annex I of Directive 98/8/EC (the BPD) for PT 8 (wood preservatives). The complete decision can be read here.

 

Non-inclusion of Formaldehyde for PT 20 in Annex I of BPD

07.05.2013
The European Commission has voted not to include formaldehyde for PT 20 in Annex I of Directive 98/8/EC (BPD). According to Commission Decision 2013/204/EU, all authorizations will be withdrawn by 1 July 2015.

 

Provisional authorizations for new plant protection actives extended

07.05.2013
The EU Commission has extended the provisional authorizations for several new active substances for plant protection, which are currently under evaluation by the Commission. These are:

Acequinocyl	Aminopyralid	Ascorbic acid
Flubendiamide	Gamma-cyhalothrin	Ipconazole
Metaflumizone	Orthosulfamuron	Pseudomonas sp. strain DSMZ 13134
Pyridalil	Pyroxsulam	Spiromesifen
Thiencarbazone		Topramezone

 

Commission Implementing Decision 2013/205/EU extends the authorizations to 30 April 2015.

 

Extension of approval period for a number of active substances

17.12.2012
Commission Implementing Regulation (EU) No. 1197/2012 amends Implementing Regulation (EU) No. 540/2011 with regard to the extension of the approval period of active substances. These substances are: acetamiprid, alpha-cypermethrin, Ampelomyces quisqualis Strain: AQ 10, benalaxyl, bifenazate, bromoxynil, chlorpropham, desmedipham, etoxazole, Gliocladium catenulatum Strain: J1446, imazosulfuron, laminarin, mepanipyrim, methoxyfenozide, milbemectin, phenmedipham, Pseudomonas chlororaphis Strain: MA 342, quinoxyfen, S-metolachlor, tepraloxydim, thiacloprid, thiram and ziram. Read the entire document here.

 

Changes to certain heading of Annex I to Directive 98/8/EC

28.11.2012
The headings to all entries in Annex I of Directive 98/8/EC have been amended as follows:

• "Minimum degree of purity of the active substance" replaces "Minimum purity of the active substance in the biocidal product as placed on the market"
• "Deadline for compliance with Article 16(3), unless one of the exceptions indicated in the footnote to this heading applies" replaces "Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decision relating to its active substances)

The reasoning and justifications for these changes can be found in Commission Directive 2012/43/EU.