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.
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.
*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).
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.
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.