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.

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Accordingly, the following will apply:

  • Registrations, approvals, authorisations and classifications in place before March 2019 will continue to be valid during the implementation period in the same way that they are now.
  • REACH will continue to apply to the UK during the implementation period.
  • The process for registering new chemicals under REACH during the implementation period will remain the same as it is now, which will require UK companies to register with the European Chemicals Agency (ECHA).
  • During the implementation period, the UK will recognise all new registrations, approvals, authorisations and classifications granted by the EU.
  • During the implementation period, we expect that HSE will not be able to act as a ‘leading authority’ to conduct certain assessments under the Plant Protection Products, Biocides and REACH regulations. We will work with affected businesses to minimise disruption and delay to their ongoing assessments.
  • UK-based businesses will have the same rights during the implementation period as EU-based businesses to have their cases accepted and processed by ‘leading authorities’ based in other EU member states.
  • HSE will continue to process product applications under the Biocidal and Plant Protection Products Regulation for the UK market under the national authorisation route during the implementation period. Any applications will be considered against the current rules and standards. 

As stated in the draft Withdrawal Agreement, its finalisation is planned to be done by October 2018. The implementation period will consequently start on 30 March 2019 and last until 31 December 2020. For more information, please refer to HSE's website.

In a new Brexit White Paper UK reiterated its desire to form a future economic relationship with EU and ECHA. Even without voting rights UK will make sure that businesses could continue registering their substances directly on the EU and UK market without the need to work through an EU-based only representative (OR). The Paper proposes that all registrations and authorisations completed during the implementation period will be recognised as valid in EU and UK and the access to relevant IT systems will ensure the smooth transition.


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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*.

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This guidance document is based on the WHO/IPCS definition of an endocrine disruptor (WHO/IPCS, 2002). In order to establish whether the ED criteria are fulfilled, gathering, evaluating and considering all relevant information for the assessment, conducting of a mode of action (MoA) analysis, and applying of a weight of evidence (WoE) approach is necessary.
ED criteria cover all endocrine disrupting modes of action. However, the effects caused by estrogenic, androgenic, thyroidal and steroidogenic (EATS) modalities are referenced in detail in this GD since there are standardised test guidelines for in vivo and in vitro testing available (compiled in the OECD Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption, OECD GD 150). So, mammals, fish, and amphibians are the addressed species.
An assessment strategy whether a substance meets the endocrine disruptor criteria (incl. a mode of action analysis), information sources that may provide suitable information for ED identification, and recommendations for applicants and assessors from evaluating authorities are part of the GD.
Last but not least, several appendices providing information on some specific scientific or technical issues (e.g. databases, software tools and literature-derived (Q)SARs). To download the guidance, please click here.

Even with the enforced EU ED criteria and the ED guidance on hand, expert work and judgement will be needed to evaluate the putative ED properties of compounds in the forthcoming process, especially in cases where the scientific evidence is ambiguous or contradictory.
SCC has a wide spectrum of expertise in the assessment of potential endocrine disruption. This allows us to successfully anticipate regulatory challenges and confidently guide our clients through the difficulties in developing target-specific strategies. To keep up to date with every new requirement, we continuously monitor the current regulatory and scientific developments in this field, both in the EU and worldwide.
Our expertise covers the entire range of methods that can be used in the development of an appropriate assessment strategy, including mode of action (MoA) analyses and adverse outcome pathway (AOP) concepts as well as weight of evidence (WoE) approaches.
SCC will serve you as a dedicated and highly experienced partner when it comes to assembling the lines of evidence. We will support you in gathering, evaluating and putting together all relevant information required for establishing whether the ED criteria are fulfilled. 

* Date has been changed from 20 October 2018 to 10 November 2018; Corrigendum to 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 [L 111/10, 2018, Document 32018R0605R(01)]

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.
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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
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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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