Board of Appeal shines more light on the necessity of studies for long-term toxicity to fish

Date: 10 June 2020

In its latest decision, the Board of Appeal, amongst other issues, also took an important decision about the necessity of studies for the “Long-term toxicity to fish” endpoint. The endpoint cannot be simply waived on the grounds of Column 2 of Section 9.1 of Annex IX. One of the required tests has to be performed and included in the REACH dossier. The BoA decision thus needs to be carefully considered for all future dossier work incl. any updates.


The European Commission publishes a combined evaluation roadmap/inception impact assessment for the planned revision of the Sustainable Use Directive 2009/128 (SUD)

Date: 8 June 2020

Public authorities, businesses, civil society organisations and the public have currently the opportunity to give feedback on a combined evaluation roadmap / inception impact assessment for the planned revision of the Sustainable Use Directive (SUD).


New draft list of unacceptable co-formulants

Date: 5 June 2020

Early in 2020 a draft list of unacceptable co-formulants (Annex III of Regulation (EC) No 1107/2009) was published by the European Comission which included 90 entries. This list and the Regulation have been revised and new drafts were recently presented for an opinion in a SCoPAFF meeting.


Action Plan for revision of EU's agricultural legislative frameworks - Farm to Fork and Biodiversity Strategies launched by EU Commission

Date: 25 May 2020

As part of EU's Green Deal Strategy (EU Green Deal Strategy 1, EU Green Deal Strategy 2), on 20th May, EU Commission launched the new Farm to Fork and Biodiversity Strategies. Work and discussions on the new strategies were postponed several times in the recent past but lessons learned from the COVID-19-pandemic “underlined the importance of a robust and resilient food system that functions in all circumstances” and made “aware of the interrelations between our health, ecosystems, supply chains, consumption patterns and planetary boundaries” being, together with the “increasing recurrence of droughts, floods, forest fires and new pests a constant reminder that our food system is under threat and must become more sustainable and resilient”. Both strategies are “mutually reinforcing, bringing together nature, farmers, business and consumers for jointly working towards a competitively sustainable future”.


New regulation improves mutual recognition for fertiliser and biostimulant products

Date: 29 April 2020

Two years ago we reported on the revision of the EU law on the mutual recognition procedure and the free movement of goods lawfully marketed in one EU Member State (see SCC News of 28 May 2018). The new Regulation 2019/515 of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 now applies since 19.04.2020. In case of fertiliser and biostimulant registrations, first feedback from national authorities already indicate, that the new rules are implemented on national level, at least in certain Member States.


Final EU medical device regulation amendment available

Date: 27 April 2020

The amendment document relating to the dates of application of the new medical device regulation MDR (EU) 2017/745, decided by the European parliament on 17 April 2020, has finally been published and is in force. It follows the proposal of the European Commission with some minor corrections, such as considering the Corrigendum from 25 November 2019, in which a shift was already granted for certain class I devices, for which the conformity assessment procedure requires the involvement of a notified body in future.

As a result, the dates relating to the end of the transition period from the MDD to the MDR originally fixed on 26 May 2020 have been shifted to 26 May 2021. The other deadlines and implementation dates remain unchanged. If you have questions with respect to the impact on your company, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..


Eurasia REACH – Inventory notification deadline moved to 1 August 2020

Date: 27 April 2020

The deadline for the inventory submission has been moved to 1 August 2020 due to the Covid-19.  We will keep you in the loop of further developments.


Proposal for the amendment of the Medical Device Regulation (EU) 2017/745 available

Date: 6 April 2020

On 3 April 2020, the proposal for the delay of the implementation of the new MDR has been published.

In the proposal, all dates referring to the original implementation date of 26 May 2020 have been replaced by 26 May 2021, with exception of the preparation of the guidelines on phthalates. In addition to keeping the requirements for existing devices, this allows placing new or modified medical devices on the market under the Directives 93/42/EEC and 90/385/EEC up to this new implementation date next year. The deadlines for placing the UDI on the device and packaging, which were scheduled further in the future, remain unchanged.

The proposal also suggests implementing Article 59 of the MDR (EU) 2017/745 prematurely, which allows the Commission to extend, in exceptional cases, the validity of a national derogation for a limited period of time to the territory of the EU. The national derogations in Article 59 are intended to authorise the placing on the market of medical devices for which the relevant conformity assessment procedures have not been carried out, but the use of which is in the interest of protection of health.

At this moment, the delay of the MDR (EU) 2017/745 implementation is only a proposal by the European Commission, and has not yet been adopted by the European Parliament. We will keep you informed about further development. If you have questions with respect to the impact of the proposal on your company, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..


European standards for medical supplies made freely available to facilitate increase of production

Date: 2 April 2020

Due to the Covid-19 crisis, the European Commission is working with industry and Member States to maximise the availability of masks, gloves, gowns and other medical supplies.

“Upon the urgent request of the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), in collaboration with all their members, have agreed to immediately make available a number of European standards for certain medical devices and personal protective equipment. This action will help both EU and third-country companies willing to manufacture these items to swiftly start production and place products on the internal market more easily while ensuring a high degree of safety”. (Press release of the European Commission) 

The standards are available for free download from the websites of CEN national members.

Companies interested in producing medical devices or personal protective equipment and looking for additional support with respect to safety and performance requirements of medical devices are invited to contact This email address is being protected from spambots. You need JavaScript enabled to view it..


12 months delay in the implementation of the medical device regulation?

Date: 25 March 2020

Stella Kyriakides, the EU health and food safety commissioner, twittered on 25 March 2020: "Vital devices needed to treat #COVID19 patients must remain available on EU markets. For that reason, at the @EU_Commission, we are working to put forward a proposal to delay the implementation of the new medical devices Regulation by 12 months."

We will keep you informed about further development.


Coronavirus: National derogations for placing hand disinfectants on the market across the EU

Date: 24 March 2020

Several countries in the EU have published temporary legal measures to allow the production and placing on the market of alcohol-based hand disinfectants. These measures have been taken to mitigate the shortages of hand disinfectants, needed for the fight against the Coronavirus.

For example, alcohol-based disinfectants, if produced according to the formulations (based on ethanol, propanol-1 or propan-2-ol) of the World Health Organisation (WHO), are allowed to be placed on the market for and used by healthcare professionals without the need for authorisation under the European Biocidal Product Regulation (BPR) or current national systems or practice. The different national authorities are using the exemption powers under article 55 (1) of the BPR, which permit them for a period not exceeding 180 days, in case of danger to public health, animal health or the environment which cannot be contained by other means, to allow the making available on the market and use of products which do not fulfil the conditions for authorisation laid down in the BPR.

The measures and regulatory requirements vary per EU member state. Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. for more information and support.


Inventory notification period for imports of chemicals into Russia and other EAEU countries ends on 1 May 2020

Date: 19 March 2020

The implementation of the new chemical regulation for the Eurasian Economic Union (EAEU)* started on 11 November 2019 with the opening of the chemical inventory notification period in Russia. After the initial deadline expired on 1 January 2020, the Russian ministry communicated the extension of the important period until 1 May 2020.

Notification of the entire portfolio of manufactured or imported chemical substances ensures that manufacturers and importers benefit from the relatively light obligations for existing substances vs. the expected requirements for any new substances.

The EAEU Technical Regulation “On the safety of chemical products” (TR 041/2017) was published on 3 March 2017 and is planned to come into force on 2 June 2021. The inventory compilation of already existing chemicals is a pre-requisite and necessary first step in order to distinguish between existing and new chemicals.

The inventory compilation concerns all circulating chemicals regardless of their tonnage. This information needs to be submitted online to the ministry portal GISP (in Russian):

  • Substance identification information (IUPAC name, CAS and EC numbers, name in English, synonyms), uses/application, annual tonnage, applicant details, customs code, structural formula, classification

We reccomend making an inventory notification by 1 May  2020 in order to benefit from the reduced registration requirements for existing substances.

This email address is being protected from spambots. You need JavaScript enabled to view it. for more information.

 *The Eurasian Economic Union consists of these countries: Belarus, Kazakhstan, Armenia, Kyrgyzstan and Russia.


Revised completeness check: what changes and how you can prepare

Date: 18 March 2020

ECHA announced a revision of the completeness check with more explicit rules on hazard information in key endpoints and its extension to CSR. It will take effect after the release of the new IUCLID version which is scheduled for end of April 2020. Computer-based checks will ensure that specific requirements are addressed in IUCLID, e.g. for endpoints such as biodegradation, mutagenicity and reproductive toxicity. Moreover, a revised manual and standardized completeness check will check the content of a CSR and the completeness of exposure assessment and risk characterization. The one-to-one match of use and corresponding exposure scenario is very important (presence will be checked, not the quality). Here, CHESAR helps to ensure consistency between IUCLID and CSR.

In their webinar “Revised completeness check: what changes and how you can prepare” ECHA also pointed out that CSR “waiving” is valid only under very specific conditions and that e.g. the argument “no relevant release expected” is incomplete without specification / quantification. For more details please click here.


Manual completeness check of registration dossiers by ECHA

Date: 17 March 2020

In parallel to the Technical Completeness Check (TCC), ECHA now also intensifies the Manual Completeness Check of all submitted registration dossiers.
The technical completeness of the dossier can be checked using the validation assistant available in IUCLID. In addition, however, there are further issues not covered by the validation assistant but checked manually by ECHA. ECHA explains its focus points in a separate document "Information on manual verification at completeness check" (latest version of 21 February 2020) available on the ECHA homepage under "How to prepare registration and PPORD dossiers". It is thus strongly recommended to thoroughly check the IUCLID dossier for technical completeness by the validation assistant as well as the IUCLID dossier and CSR for compliance according to the latest guidance before submission to ECHA (see also the next article on the revised completeness check).


BREXIT – Update for the chemicals sector

Date: 16 March 2020

Since 1 February 2020 the UK is not a Member State of the EU any more. During the transition period that has been agreed to last until 31 December 2020, current terms of market access and thus EU-UK trade remain unchanged.

What does it mean for businesses operating in the chemicals sector?

  • EU REACH continues to apply to the UK (and so the UK will continue to implement REACH decisions, but it will not be actively involved as a ‘leading authority’ any longer).
  • All registrations, approvals, authorisations and classifications in place before the UK left the EU on 31 January 2020 continue to be valid.
  • UK companies still need to register chemical substances under EU-REACH.
Whereas the legal and regulatory status for all the actors in the chemical industry is clear and reliable (at least) until the end of the year 2020, the outlook into the future EU-UK trade relationship and its impact on the chemical industry are almost impossible to predict at the moment. In their regulatory opening positions prior to entering the expectedly difficult negotiations (published on 3 February 2020), significant divergence between the EU and the UK has emerged. This means that the possibility of a no-deal scenario is not ruled out,  in case both sides can't make mutually accepted agreements on the future standards and regulations for chemicals.

Annex III of Regulation 1107/2009 (unacceptable co-formulants)

Date: 29 January 2020

On 16 January 2020 European Commission published draft regulation amending Annex III to Regulation (EC) 1107/2009 of the European Parliament and of the Council and draft list of co-formulants which are not accepted for inclusion in plant protection products. Both documents could be downloaded at the EC website and are open for comments for 4 weeks (16 January 2020 - 13 February 2020). Comments will be published on the EC website later on.

Follow up on admissibility of use restrictions set by German UBA for pesticide authorisation

Date: 29 January 2020

The administrative court of Braunschweig decided on non-compatibility of Biodiversity use restrictions required by the Federal Environment Agency (UBA) with applicable law last year. We already reported on this issue in our SCC Newsletter Vol. 16 No. 4 and under current news on 25 October 2019.

The following information is now available: UBA has started to review and replace all use restrictions concerning biodiversity. The Federal Office of Consumer Protection and Food Safety (BVL) is currently examining UBA's new procurement practice, both professionally and legally. If you need further information, please contact us.


Additional evaluation time due to RMS re-allocation

Date: 28 January 2020

Applicants must be aware that due to the Brexit and the RMS re-allocation from the UK to other member states, delays in evaluations are expected. In the specific case, the time frames for an active substance were postponed by 5 months to allow sufficient time for the new RMS to take over the tasks and responsibilities from the former RMS UK, following their request, the discussions of the substance in the peer review expert meetings. This cause also delays in the overall timeline for the completion of the peer review for this substance.

Additional evaluation time due to RMS re-allocation

Date: 28 January 2020

Applicants must be aware that due to the Brexit and the RMS re-allocation from the UK to other member states, delays in evaluations are expected. In the specific case, the time frames for an active substance were postponed by 5 months to allow sufficient time for the new RMS to take over the tasks and responsibilities from the former RMS UK, following their request, the discussions of the substance in the peer review expert meetings. This cause also delays in the overall timeline for the completion of the peer review for this substance.

Amendment of Regulation (EU) 844/2012

Date: 27 January 2020

On 24 January 2020, EU Commission published the regulation (EU) 2020/103 to amend the regulation (EU) 844/2012.
The main changes are the additional time for the preparation of the draft renewal report by the RMS and for circulating the RAR by EFSA.
The RMS have now 13 months (instead of 12 months) for its evaluation and the preparation of renewal assessment report, whereas EFSA has now 3 months (instead of 30 days) for circulating the RAR.
These additional evaluation times lead to a reduced submission time for the applicants. It applies to those active substances for which the approval period expires on or after 13 May 2023. Concerned applicants must submit the supplementary dossier three months earlier; i.e. 33 months before the expiry date of the approval of the a.s. (formerly 30 months).

According to the new regulation, the RMS must also submit a proposal on a harmonised classification of the active substance to ECHA at the latest at the time of submission of the draft renewal assessment report. In case a proposal has already been submitted to ECHA, the RMS should limit the proposal to the parts that are not covered. In the case of an already existing opinion the RMS should justify that the opinion remains valid. The preamble point 7 of regulation (EU) 2020/103 elaborates that “Indicative timelines should be defined to ensure that the opinion of the Committee for Risk Assessment of the Agency is available to the Authority prior to the adoption of its conclusion under Article 13 of Regulation (EU) No 844/2012”. So, our recommendation is that applicants should discuss the final deadlines for submission with the respective RMS, especially when an ECHA opinion is already available and this opinion should not be changed/re-evaluated.