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.
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).