Non-food legislation - March 2019

28 March 2019

REACH data compliance needs to improve. ECHA has published its annual evaluation report, delivering updated statistics on evaluated substances and registration dossiers, and giving advice to registrants on how to improve the information they provide on chemicals.
The first final version of the Annex VIII Guidance has been published. Version 1.0 of the Guidance on harmonised information relating to emergency health response (1.21 MB) is now available on the Guidance on CLP section on ECHA’s website.
Is Bisphenol P a safe alternative? The substance 2,2-bis(4'-hydroxyphenyl)-4-methylpentane, also known as Bisphenol P, has been added to ECHA’s candidate list of substances of very high concern (SVHCs) following the proposal from the Swedish Chemicals Agency. According to the KEMI report about Bisphenols (3.35 MB, in Swedish with English summary) they have identified over 200 substances with a chemical structure similar to BPA and which can occur on the European market.

Labelling requirements for hazard communication and ecolabelling
ReSolve project partner, nova-Institute, published a report (1.70 MB) that focusses on relevant European regulation in a global context to assess and give recommendations for labelling requirements for hazard communication and ecolabelling possibilities for bio-based solvents.

Pharmaceutical packaging
European Pharmaceutical Review published an article by Stephen Wilkins (you can access the full article after filling in your details), Chairman of the Child-Safe Packaging Group about pharmaceutical packaging: child-resistant, easy opening, sustainable. In this article he discusses the standards that govern child-safe packaging, as well as the importance of ‘ease of opening’ for elderly adults.
An article about how digital healthcare and packaging benefit users has been published in Packaging Digest. A deep dive into global digital healthcare trends exposes the pros and cons of using technology in decidedly human applications. After a thorough explanation of market drivers, the authors focus on primary and secondary packaging that can enhance distribution safety, improve compliance and perhaps offer an alternative for drug manufacturing.
A Biospace article describes some of the steps that the FDA took in 2018 to address the opioid crisis. In 2019, they plan on taking new actions to build on these efforts, and also adapt the response to confront the changing nature of the threat. This includes allowing other packaging formats, including blister packs, for opioids.
Together with Bogin, Neprofarm, and KNMP, the Association Innovative Medicines has drawn up the next Dutch Sustainable Packaging Sector Plan. More information is shared in a news item by the Association Innovative Medicines (in Dutch). The Sector Plan, which is a continuation of the 2015-2018 plan (715 kB, in Dutch), contains proposals to reduce packaging in the pharmaceutical sector and self-care and to make it more sustainable for the period 2019-2022. Some of the possibilities that are discussed are preventing the waste of medicines, and therefore also of packaging, recycling blister strips, and in time replacing the paper package leaflet with digital information.

NVC members receive this information with all the relevant links in the monthly NVC Members-only Update. If you have any questions, please contact us:, +31-(0)182-512411.