Non-food legislation – May 2020

29 May 2020

Hazardous substances
EU: The EC has published a roadmap (266 kB) for its chemicals strategy for sustainability. The roadmap is open for feedback until 20 June 2020. SGS reports that the EU has informed the WTO of its intention to revise Annex XVII of REACH. The RIVM reports that Germany, the Netherlands, Norway, Sweden and Denmark have agreed to prepare a REACH restriction proposal to restrict the manufacturing, the placing on the market and the use of all PFAS in the EU. Companies, scientists and NGOs ’s are invited to fill in a questionnaire, before 31 July 2020. ECHA has updated the downloadable set of non-confidential REACH registration data. The dataset contains key information on around 23 000 chemicals. During SETAC SciCon, held 3-7 May 2020, ECHA gave a number of presentations (33 kB) on REACH. The ECHA 2019 report (2.08 MB) on the Integrated Regulatory Strategy was recently published. It gives an overview on the progress in addressing substances of concern and in the “mapping of the chemical universe”. In 2019, ECHA moved from a substance-by-substance approach to addressing structurally similar chemicals in groups to speed up identification and management of the risks of hazardous chemicals. China: FPF reports that the final version (in Chinese) of revised legislation regulating new chemical substances has been published. NL: 17 PGS (in Dutch) guidelines were recently sent to the European Commission for notification. A number of PGS guidelines was not ready on time so it was decided to publish these guidelines as an interim version, including PGS 15 (in Dutch) for the storage of packaged dangerous substances.

Covid-19 - Regulations for medical devices and pharmaceuticals
EU: A recent EC Q&A document (405 kB) has been updated to address challenges arising from the Covid-19 pandemic. It states for example that in the current exceptional circumstances, the regulatory flexibilities foreseen in the Directive 2001/83/EC should be fully utilised. Under Article 63, Member States may grant full or partial exemptions to certain labelling and packaging requirements to address severe problems in respect of the availability of medicinal products. Regulation 2020/561/EC has been published in the OJ. It postpones the date of application of the Medical Devices Regulation by one year until 26 May 2021, allowing member states to prioritise the fight against Covid-19. India: The government has announced (114 kB) that it is allowing companies to use pre-printed packaging material stock till 30 September 2020 due to the Covid-19 pandemic.

Counterfeit pharmaceuticals
Recent seizures of fake medical supplies being marketed as protection against Covid-19 underscore the need to address a growing international trade in counterfeit pharmaceuticals, according to the OECD and the EUIPO. They published a joint report (4.49 MB), Trade in Counterfeit Pharmaceutical Products, and an accompanying brief (103 kB) on links with the Covid-19 crisis. Interpol has also reported a rise in fake medical products related to Covid-19.
A West Virginia University study has indicated that spectroscopic tools are effective in discriminating between authentic and counterfeit pharmaceutical packaging. Emily Ann Haase wrote her thesis (11.96 MB) about this study.

ANSM (in French) and DGCCRF have published recommendations for the French cosmetics industry for a better use of "free from" claims.

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