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:

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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.

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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.

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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.

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The Code of conduct comprises voluntary standards of practice for all stakeholders and it was obtained by public consultation. It aims in generating a sustainable agriculture and food security from a nutrient management perspective. In more detail it intends to

  • be a response to the requests of the COAG (Committee on Agriculture) to increase food safety and safe use of fertilisers
  • facilitate the implementation of the VGSSM (Voluntary Guidelines for Sustainable Soil Management) to address nutrient imbalance and soil pollution
  • respond to the UNEA3 (United Nations Environment Assembly of the United Nations Environment Programme, 3rd session) declaration on soil pollution

It designates actions to governments, policy makers, the fertiliser industry, academia, research, agricultural and analytical service laboratories, agricultural extension and advisory services, civil society and users of fertilisers, including farmers. It gives advices in the field of

  • soil fertility and plant nutrition
  • fertiliser use and management
  • nutrient reuse and recycling
  • composition, limits and testing
  • access, distribution and labelling
  • information, extension and outreach
  • monitoring and observance

Additionally, the document includes terms and definitions commonly used in the field of fertilisers.
In the EU, several of these topics, especially the use and management of fertilisers, are already addressed in the new draft of the fertiliser/biostimulant regulation and are also part of the circular economy package.
For further information on the future EU fertiliser framework please refer to SCC’s news, published on the 28th May 2018.


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

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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 the link.

Dr Lars Huber, Head of Biostimulants, Fertiliser, IPM

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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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