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ECHA has critically reviewed the current process and based on the experience of the past ten years decided to introduce some changes. As a major change ECHA will extend the scope of the compliance check to all relevant dossiers within a joint submission. In particular, this will affect the following most important points:

• In the future, ECHA will firstly check the lead dossier, and, if present, the boundary composition. Subsequently, ECHA will screen the members’ dossiers to identify whether the composition is consistent across the joint submission (and consistent with the substance identity profile, SIP) and whether deviations may impact the hazard assessment.
• Partial or full opt-out dossiers will be assessed at the same time as the data submitted jointly. This will result in a separate decision addressed only to the relevant opt-out registrants.
• CSR related issues will no longer be included in the draft decision unless the CSR is jointly submitted and the request refers to completeness in the sense of e.g. missing exposure assessment or missing exposure scenarios.
• Once a draft decision is issued, registrants will need to comply with the requests in the decision according to the tonnage declared when receiving the draft decision. It will no longer be possible to change the tonnage band or the type of registration (full vs. intermediate) as soon as a draft decision is issued by ECHA. ECHA will no longer consider second attempts made for waiving an endpoint (e.g. a new read-across) via dossier update during an on-going compliance check procedure.
• As a general rule, ECHA will no longer offer an informal communication to the registrants after the draft decision is issued.
• ECHA will stop publishing a list of substances which are potentially candidates for compliance check.

ECHA strongly highlighted that “as the phase-in registration period is now over, registrants should shift their attention to the quality of their dossiers and update them without undue delay, as stipulated in Article 22.” Subsequently, ECHA expect that registrants comply with their obligation and ECHA will consistently apply its expectation in the dossier evaluation process.

Thus, ECHA is expecting dossiers to be up-to-date and will not inform registrants or grant a chance for dossier updates prior to regulatory measures.
In light of the planned changes, ECHA strongly encouraged registrants to take a pro-active role, to review the dossiers and update them, if necessary, without waiting for an alert or a draft decision.

SCC has a lot of experience in preparing and updating REACH dossiers according to the current REACH requirements.

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Dr Vorwerk presented the following measures to improve the data quality:
•    Significant streamlining of evaluation procedures. Until now, it usually takes several years for missing data to be submitted or for erroneous data to be corrected.
•    Substantially increase the administrative resources used, including discussing how registrants should share the costs and what incentives should be put in place to ensure that information is provided in the required quality from the outset.
•    The Commission could examine measures to improve own-initiative updating under Art. 22 REACH and could also consider the question of regular updating requests.

The most remarkable statement is that the German authority aims to evaluate all REACH dossiers within the next 10 years. This is of course currently not an agreed position between member states but should raise attention in industry.

The position of Germany again emphasises that REACH is not done after the last registration deadline has passed. You should stay tuned and plan your capacities for dossier updates and substance/dossier evaluation accordingly.

To find out more details, please download the presentation (only in German available).

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• The legal text and ECHA guidance leave it open how exposure scenarios of substances are to be included into the mixture safety data sheet (SDS).
• There is no common understanding whether an SDS for a mixture should have an exposure scenario (ES) Annex like the substance-related SDS, and whether users of mixtures have downstream users’ duties under REACH.
• Similarly, the relationship between the ES Annex and Sections 7 and 8 of the SDS is not clearly described in Annex II of REACH, and thus leads to difficulties for recipients of an SDS to identify the information needed for checking their conformity.

The lack of harmonisation/standardisation regarding the data format of the extended SDS prevents the transfer of data in a way that IT systems could directly process the information received. As a consequence, at the moment, all information is to be uploaded manually into tools for processing (when they exist), which consumes a lot of resources and is error prone.

In addition, there is no common assessment standard supporting all the expected processing of safe use information through the supply chain by the various actors. IT providers have developed a variety of solutions for some of the tasks (mainly based on the clearly enforceable duties). The language of the Annex to the safety data sheet is an illustrative example, easy to check for inspectors but coherent translation is very challenging for IT providers.

The Commission (COM) and ECHA thus called for feedback regarding the experience with current (harmonised) formats and IT tools. Afterwards COM and ECHA will organise a workshop to make proposals for follow on work. The Commission considers including minimum requirements for the exposure scenarios for substances and mixtures in Safety Data Sheets and requesting ECHA to develop a methodology for Safety Data Sheets for mixtures. The results thereof and possible implementation in the legal text may require years. Until then the current status remains.

The Exchange Network on Exposure Scenarios (ENES) has developed harmonised formats and IT tools (e.g the EuPhraC catalogue for standard phrases). However, uptake and use of the ENES tools remains limited.
Within this context please refer to our news item regarding eSDS translation.

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The definition of chemical composition change follows EU Guidance document SANCO/12638/2011, whereas any further details about formulation types are given in Manual on development and use of FAO and WHO specifications for pesticides (FAO and WHO, 2016).
The first part of the Standard provides a description of the criteria which are relevant to efficacy of the key components and types of changes which may have an impact on relevant efficacy properties, especially effectiveness and selectivity of a plant protection product.
In the decision process it is essential to have information regarding the nature and magnitude of the proposed change. This encompasses information on the chemical nature of the co-formulant(s) being changed, and explanations of their chemical similarity, if relevant.
For changes which have only a non-significant impact on biological aspects of a plant protection product, no efficacy data are required. Even though no special efficacy data are required, an explanation of the biological non-significance of the composition change should be given as an integral part of a justification to explain why the proposed change is considered as unlikely to have an impact on efficacy.
On the other hand significant changes in chemical composition are those regarded to have some potential impact on the biological activity of a plant protection product, requiring assessment and supporting data. Of special relevance for most formulation types, e.g. for foliar applied products, are changes in the solvent and the surfactant system.
The second part of the new Standard provides substantial information about the type and extent of data required for biologically significant formulation changes. The scope of data to be submitted depends on how similar the new formulation is to the existing one of the already approved product. The new Standard gives detailed recommendations for the necessity of glasshouse or field trials, distribution of trials and the number of trials to be provided to authorities, depending also on formulation types with the main focus on efficacy and selectivity trials.
If comparability in trials based on a trial program as outlined above could not be demonstrated, further efficacy data may be required. In the worst case, even a full data set according to EPPO Standard PP 1/226 Number of efficacy trials might be needed, if the old and new formulation are proved to be not comparable.
Further detailed information concerning any potential impact of a chemical composition change on the generation of efficacy data will be provided in the forthcoming SCC Newsletter.

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The new EPPO Standard describes in detail the potential advantages and disadvantages of mixtures with respect to the effectiveness which is to be considered when preparing an accordant justification as part of a submission. Accordingly, the comparison of a mixture with the respective solo products should be used as a benchmark. The Standard also represents the general principles to be taken into account for mixture justifications as well as the issues relevant for the justification of mixtures as part of resistance management.
Helpful for applicants is the checklist attached to the new Standard specifying the key issues to be considered when supporting the authorisation of a mixture. The most relevant principles encompass i.a. the efficacy of mixtures (e.g. whether there is a clear benefit), the ratio of active substances in mixture products, resistance or relevance of a mixture across the EPPO zone.
In addition, the Standard provides further details for mixtures of fungicides, herbicides, insecticides, seed treatment products and plant growth regulators. In this context please note that the old standard PP 1/277 Insecticide co-formulated mixtures has already been withdrawn and been replaced by the new standard.
Further information concerning the principles requested for mixture justifications will be provided in the forthcoming SCC Newsletter.

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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.

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• 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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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)]

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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.

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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

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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.

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• 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.