Next steps for polymer registration in South Korea
Date: 24 November 2020
After taking a close look at the new guidance on polymer registration in South Korea, SCC's and TSafeG's regulatory experts in their feature article for Chemical Watch provide a concise summary of the most crucial and critical parts of the guidance from defining a polymer and specifying the data requirements to identifying potential challenges. Read the full article.
For any questions on K-REACH, please do not hesitate to contact our South Korea expert This email address is being protected from spambots. You need JavaScript enabled to view it..
How does South Korea's simplified K-BPR approval process work?
Date: 26 October 2020
Ji Yeong Kim, our Asia regulatory affairs expert, provided in her focus feature for Chemical Watch an overview of South Korea's newly adopted simplified K-BPR approval process. There she explains which active substances are subject to the simplified approval and gives useful information, such as the required data, the timing of the procedure and other insights helpful for those submitting biocidal active substances for approval under this new process. Read the full article on the simplified K-BPR approval process here.
For any questions on K-BPR, please do not hesitate to contact This email address is being protected from spambots. You need JavaScript enabled to view it..
EU Commission reports on Harmonised Risk Indicators (HRI)
Date: 8 September 2020
Based on the EU Thematic Strategy on the Sustainable Use of Pesticides, Regulation 1185/2009 concerning statistics on pesticides established the basis for collection of data on pesticide use as well as for implementation of Harmonised Risk Indicators in EU. Due to the lack of progress in this regard on Member State Level, on 15 May 2019 Commission Directive (EU) 2019/782 was adopted, establishing harmonised risk indicators to estimate the trends in risk from pesticide use (for detailed information please refer to SCC Newsletter Vol. 18, No. 6 of December 2018). Subsequently EU Commission launched their Webpage on Trends in Harmonised Risk Indicators for EU and Member States to make the respective results public.
Public consultation on Organic Farming Action Plan launched –
EU Commission proposes postponement of entry into force of the new organic legislation by one year
Date: 8 September 2020
Organic farming is a very dynamic, rapidly growing and changing sector whereat the EU is the second largest consumer of organic food in the world with annual retail sales of more than EUR 37 billion and an increase of more than 65% over the last 10 years. To adapt the respective legislation to these rapid changes, a new Regulation (Regulation 2018/848 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007) was developed which was due to enter into force from 1 January 2021 onwards.
UK Government has published new guidelines on UK REACH
Date: 4 September 2020
The UK has left the EU, and the transition period after Brexit comes to an end this year.
The UK government has published new guidance on how to comply with REACH chemical regulations from 1 January 2021.
Please contact our experts to learn more about the impact of the new UK regulatory regime on your products and how we can help you.
Data requirements for biopesticides in EU: problems and needs
Date: 26 August 2020
In the article recently published in Agrow’s Biologicals 2020, SCC’s regulatory experts Dr Lars Huber and Dr Carla Lorenz together with Dr Hermann Strasser, Senior Scientist from Leopold-Franzes University Innsbruck, provide a critical analysis of the data requirements for biopesticides in the EU. The authors share detailed insight into the current EU biopesticides regulation examining recent changes and current problems that need to be solved. To read further, download the full article.
Grandfathering – all you should know about legal entity transfers
Date: 25 August 2020
Chemicals legislation in the UK after the end of the transition period (31st December 2020) is subject to the ongoing EU-UK trade negotiations, and the precise details are still being decided. In case there will be no agreement between the EU and UK on how to handle chemicals and access to the ECHA or EU REACH, a “No Deal” scenario, the so called UK REACH, will be implemented.
Under UK REACH, existing EU REACH registrations held by UK-based companies (including registrations held by an existing OR) will be automatically ‘transferred’ and become UK registrations, so called "grandfathering".
According to the UK Health Safety Executive (HSE), to be "grandfathered" into UK REACH, a UK company should have a EU registration granted at some point from the date the UK indicated its intention to leave the EU. The company would not necessarily have to be the registration holder on the day the UK officially left the EU (31st January 2020) or at the end of the transition period. This means, UK companies could transfer their registrations to other EU companies before the end of the transition period, and still see their EU registrations grandfathered into UK REACH.
SCC establishes a presence in UK
Date: 20 August 2020
SCC has recently founded SCC Scientific Consulting Company UK Ltd, which is an important milestone ensuring the continuity of our regulatory support on the UK market.
SCC UK will initially be dedicated to providing Only Representative services under the UK REACH regime. However, we see this is a great opportunity and a significant contribution to develop our services for our customers across the world.
Please contact our experts if you want to know more about the impact of new UK regulatory regime on your products and how we can help you.
Opportunities or challenges? – Recent changes in EU registration policy of biorationals
Date: 24 July 2020
Dr Lars Huber, Head of Biorationals, Fertilisers and IPM, talks in his interview with AgroPages, published in 2020 Biologicals Special, about the regulatory consulting business and recent changes in the EU biopesticide and fertiliser registration policies. He refers to future chances and existing hurdles in the way of EU-harmonised regulation.Read the interview with Lars or follow the link to download the full supplement 2020 Biological Special.
KKDIK pre-registration in Turkey ends 31 Dec. 2020! Do not miss it!
Date: 22 July 2020
The KKDIK regulation (Turkey REACH) came into effect in December 2017. As a first step, all substances manufactured or imported into Turkey with a volume ≥ 1 ton per year (on their own, in mixtures, or in articles) have to be pre-registered by the end of 2020.
After a 2.5 years pre-registration period, more than 18,000 substances have already been pre-registered by more than 850 companies. How about you?
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.
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 Appellant had claimed that the legal text in Column 2 of Section 9.1 of Annex IX of the REACH Regulation is a “trigger” for performing a long-term toxicity test with fish, while the Agency (ECHA) claimed that it is a “possible waiver”. Column 2 of Section 9.1. of Annex IX provides: ‘Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.’
The BoA stated that the information requirements in Annexes VII to X are cumulative and must therefore be looked at as a whole, thus, they looked into detail at the Column 2 adaptations in Annex VIII (short-term toxicity to fish) and in Annex IX (long-term toxicity to fish). The BoA came to the conclusion that both the Appellant and the Agency were interpreting the legal text incorrectly.
According to the BoA, registrants at the Annex IX or X level are required to carry out one of the three long-term toxicity tests to fish listed in Annex IX as a standard information requirement, with the option to forgo the short-term toxicity test to fish required under Annex VIII. The text in Column 2 of the same section does not allow the registrant to forgo the performance of a long-term fish test based on the outcome of the performed chemical safety assessment. According to Column 2 of Section 9.1.6. of Annex IX, the registrant may be required to further investigate the properties of the registered substance in light of prolonged exposure and/or different study design based on the chemical safety assessment by performing additional longer-term toxicity tests with fish, e.g. OECD 234 – Fish Sexual Development Test.
In the light of this BoA decision, it is clear that the endpoint ‘Long-term toxicity to fish’ can not be legally waived based on Column 2 of the respective annex and one of the required tests has to be performed and included in the dossier.
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.
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.