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
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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.

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Within most OECD member states microorganisms are approved on strain level. Therefore, the evaluation should compare two sources of technical active substances of the same strain of a microorganism for several parameters aiming to ensure that the new source is equivalent to the approved (reference) source. Such parameters are the identity of the microorganism, the content of the active microorganism in CFU, the content of toxins, metabolites or contaminants and the composition of material for production (e.g. inoculum). A new source is considered as technically equivalent in Tier I, when the content of the active microorganism is higher than or equal to the reference source, the content of relevant metabolites, toxins and microbial contaminants is lower than or equal to the reference source and the composition of the material for production is the same. If  above criteria are not fulfilled, the technical grade active ingredient can be considered under a Tier II approach which assesses whether the changes in composition are without increased risk to human health and the environment.
The procedure for the assessment of the equivalence of new sources of technical materials includes an application for equivalence by the applicant. To facilitate the evaluation process the applicant may already submit a pre-filled report. After application, the reporting country is responsible to prepare the evaluation report on equivalence.  A draft version of the evaluation report will be circulated for commenting before final decision.
Please click here to read the full text of the guidance document.

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

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For further information on the new EU fertiliser/biostimulant regulation, please refer to SCC’s news published on 6 November 2017 and 23 October 2017, special edition of SCC Newsletter or the critical review on current development of biostimulants.

In addition to the future possibilities for registration of harmonised fertiliser and biostimulant products under the new EU regulatory framework, on 18 May the Council published a “Proposal for a Regulation of the European Parliament and of the Council on the mutual recognition of goods lawfully marketed in another Member State (first reading) - General approach” (Status: first reading, Council). The Regulation intends to “strengthen functioning of the internal market by improving the application of the principle of mutual recognition”. It is acknowledged that the current “Regulation (EC) No 764/2008 has several shortcomings, and should therefore be revised and strengthened”. The new Regulation shall “establish clear procedures to ensure the free movement of goods lawfully marketed in another Member State and to ensure that free movement can be restricted only where Member States have legitimate public interest grounds for doing so and the restriction is proportionate. It ensures that existing rights and obligations deriving from the mutual recognition principle are observed, by both economic operators and national authorities”.

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

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According to this guidance document, the dose for vertical crops (where upward or sideward directed spray application is used) has to be expressed for zonal (BE as zRMS or cMS) as well as for national dossiers as dose rate per hectare of Leaf Wall Area (LWA), in addition to the dose rate per hectare ground surface. This is in line with the EPPO standard PP 1/239(2) on dose expression for plant protection products. The up to now additionally given information on the authorisation certificates from Belgium of the dose/ha ground surface of a standard orchard for apple and pear will no longer be mentioned on future authorisation certificates.
Furthermore, attention is drawn within the Belgian guidance document to the bullet points on transition phase for adopting LWA, released by the Central Zone Steering Committee (CZSC via CIRCABC; click here to view the document). Accordingly, beginning with 1 January 2020 application dossiers for new products intended to be used for the vertical crops grapevine, pome fruits and high growing vegetables in the Central Zone will only be accepted when the efficacy trials were conducted based on the LWA concept. Consequently, efficacy trials for these crops carried out after1 January.2018 will only be accepted in future applications if they have been conducted on basis of the LWA dose expression. Furthermore, the dose rate per hectare of LWA has to be included in the GAP table (either in column 14 – remarks or 10 to 12 – application rate), restricted by the maximum rate per hectare ground surface and the range of possible concentrations.

Information referring to these bullet points from the CZSC was also published in 2018 by further countries, e.g. Germany and the United Kingdom.

Based on the information provided by Germany and Belgium, the data needed for calculation of LWA should also be recorded in residue trials, as the concept of LWA might also apply in future for residue calculations, and therefore the possibility for conversion of dose expression used in the residue trials should be granted.

Jasmin Philippi, Assistant Manager Regulatory Affairs, Agrochemicals and Biopesticides - Biostimulants, Fertiliser, IPM
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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.

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To fully deploy the benefits of precision/digital farming systems, data access and sharing has to be regulated and transparent rules have to be implemented for a huge variety of data on land, livestock, machines, climate, compliance and finance and different data sources such as farm data incl. agronomic, compliance and livestock data, machine data, agri-supply data (e.g. on fertilisers or plant protection products) or agri-service provider data. The new, non-binding code of conduct provides respective guidance especially taking into account data ownership and farmer’s needs, collection, access, storage and usage of data as well as the further development of precision/digital farming systems.

Annex 2 of the Code of Conduct includes case studies for different situations of data ownership considering different data sources and types including for example pest alert systems or agricultural contractors.

Besides Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, Annex 3 of the Code of Conduct also provides further information on the relevant EU regulatory frameworks concerned.

For further information on the new Code of Conduct see also the websites of the organisations and associations involved:
CEJA (European Council of Young Farmers): www.ceja.eu
CEETTAR (European Organisation of Agricultural, Rural and Forestry Contractors): www.ceettar.eu
CEMA (European Agricultural Machinery): www.cema-agri.org
COPA (Committee of Professional Agricultural Organisations): www.copa-cogeca.be
COGECA (General Committee for Agricultural Cooperation in the European Union): www.copa-cogeca.be
ECPA (European Crop Protection Association): www.ecpa.eu
EFFAB  (European Forum of Farm Animal Breeders): www.effab.info
ESA (European Seed Association): www.euroseeds.eu
FEFAC (European Feed Manufacturers' Federation): www.fefac.eu
Fertilizers Europe: www.fertilizerseurope.com

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

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Consequently the commission modified the wording of its statement as follows:
“[…] the Commission wishes to clarify that if a manufacturer or importer of a phase-in substance, who has pre-registered that substance, exceeds the 1 tonne per year threshold in 2018, based on the 'three-year average' rule in Article 3(30), but has ceased the manufacture or import of that substance before the final registration deadline on 1 June 2018, then he will not be required to register after the deadline has passed unless he subsequently restarts the manufacture or import of the substance and the conditions of Article 6 of REACH are met.”

Taking this updated statement into account the Commission’s interpretation is in-line with the interpretation of the national helpdesk, ECHA’s F&Q and the ECHA guidance documents.

We would like to point out that one should closely monitor the manufacturing / import of substances until the deadline in order to ensure that no import or manufacturing takes place after 31 May 2018 which results in an overall tonnage above 1 tpa. Please keep in mind that the time point for import is the arrival of the shipment at the European customs clearance.
In case you have any questions or need further support, please get into This email address is being protected from spambots. You need JavaScript enabled to view it. with us.

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

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It lists OECD test guidelines that will be accepted in submissions to the Agency for single chemicals. For the time being, alternative testing will be accepted only for pesticide active and inert ingredients, but not yet for formulations. However, the agency states that it expects expansion of this interim policy in the near term to include some pesticide formulations or other mixtures evaluated by OPPT.

In contrary to the situation in Europe where a clear guidance for the regulatory interpretation of the alternative method is still pending, EPA has defined clear criteria how the results of the alternative test methods should be handled.

The two following defined approaches (DA) will be accepted by EPAs as alternatives to the LLNA for regulatory submission:

  • Adverse Outcome Pathway (AOP) “2 out of 3”
  • Key events (KE) 3/1 sequential testing strategy (STS)

The first DA was initially submitted to OECD by BASF and reflects the current approach used for the non-animal test strategy in the scope of EU REACH (SCC Comment: The “2 out of 3” approach is not yet officially confirmed by ECHA): At least two studies need to be conducted in order to assess two different key events. If these studies provide discordant results, a study for a third key event needs to be performed. The overall result is based on the two concordant findings. In case two positive findings are revealed this leads to a conclusion as sensitizer.

The second DA reflects a simple decision tree that requires only two studies. The first study investigates the key event 3 (Dendritic cells). If the response is positive, the test substance is classified as a sensitizer. If a negative result is obtained from a key event 3 assay, an assay for key event 1 (covalent interaction with skin proteins) is conducted. A negative study for key event 1 confirms that it is a non-sensitizer and a positive result for key event 1 leads to a finding of sensitizer.

A project proposal was submitted to OECD jointly by the US, EU, and Canada to develop a new performance-based test guideline (PBTG) for defined approaches for skin sensitization. As part of the work on the future OECD PBTG guideline, refinements and updates to some of the defined approaches are expected in the near-term (until end of Q4 2018).

SCC's conclusion is as follows: In case companies already generated data for skin sensitisation for chemicals subjected to registration under REACH using the “2 out of 3”, these data will be accepted by EPA and thus additional animal studies do not need to be conducted in order to comply with US data requirements in the near future.

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

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Advancement of organic farming is already well established in different political and regulatory frameworks, such as the Common Agricultural Policy (CAP) or the Directive for sustainable use of pesticides (SUD  2009/128). To further boost organic farming in EU the new Regulation allows for a mixed production of organic and conventional food on one holding and simplifies the certification for small farmers (group certification) to encourage conversion.

Furthermore, the new Regulation implements strict, risk-based checks along the organic supply chain and phases out the current “equivalence” rules for imports of organic goods within five years after entry into force.


In regards to plant protection, “the new rules are not very different from the current legal situation” says rapporteur MEP Martin Häusling. Main focus is to avoid contamination from chemical pesticides or synthetic fertilisers. In order to further improve respective standards, a new set of measures is implemented by the Regulation. Effectiveness of these new EU anti-contamination rules and national thresholds will be checked four years after entry into force of the new regulation and if need be the Commission is to come up with a draft law to harmonise them. For further information on pesticide residues in organic food see also the supporting publication by European Food Safety Authority, 2018: Monitoring data on pesticide residues in food: results on organic versus conventionally produced food. EN-1397. Click here to view EFSA's publication.

Read also the Provisional Edition of the European Parliament legislative resolution of 19 April 2018 on the proposal for a regulation.
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’.

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The aim of the proposal is to ensure more transparency on safety related information used for risk assessments for substances and products used in the food production chain (regulations to be amended see below) by:

  • Ensuring for public access to all relevant information
  • Establishing a common European Register of commissioned studies for all regulatory frameworks in the food chain
  • Possibility for additional studies to be requested by EFSA and financed by EU budget
  • Consultation of stakeholders and the public on studies submitted in the registration process
  • Increase Member States' involvement in the European Food Safety Authority's (EFSA) governance structure and scientific panels
  • Strengthening risk communication to citizens
Confidentiality of studies/information provided in the registration process will be maintained. The new Regulation will contain a positive list of confidential items to safeguard commercial interests of applicants.
As the fitness check on the General Food Law Regulation has also shown that the approval/authorisation procedures for several sectors are long-lasting and thus slow down the market entry process of the respective products, a closer involvement of EFSA, for example in the pre-submission procedure, may contribute to a faster and more streamlined registration process.
Vytenis Andriukaitis, the European Commissioner for Health and Food Safety called for a fast entry into force of the new Regulation, i.e. early 2019, whereat for specific issues, such as the expansion of the Management Board specific timelines are set in the Regulation. 

Amended Regulations/Directives:

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM
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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

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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.“ 

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In addition to that warning message, EU Commission published a question and answer document on the Brexit. In this paper, important questions on, for example UK company locations and UK manufacturing sites are addressed.

Click here to find the full text of the European Commission notice and here for the related document.

You may also refer to the corresponding link: https://ec.europa.eu/food/plant/pesticides_en

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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.
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