Non-food legislation - January 2019

12 February 2019

Managing chemicals in plastic packaging
Food Packaging Forum reports about a research project that demonstrates lack of transparency on chemicals in plastic packaging and identifies phthalates as urgent substitution candidates; non-intentionally added substances pose unique assessment challenges. The article ‘Overview of known plastic packaging-associated chemicals and their hazards’ has been published in Science of the Total Environment.

The European Commission has amended the list of restricted substances in Annex XVII to REACH with regard to:
•        diisobutyl phthalate (DIBP) (EC 201-553-2; CAS 84-69-5);
•        dibutyl phthalate (DBP) (EC 201-557-4; CAS 84-74-2);
•        benzyl butyl phthalate (BBP) (EC 201-622-7; CAS 85-68-7); and
•        bis(2-ethylhexyl) phthalate (DEHP) (EC 204-211-0; CAS 117-81-7).
Eurofins gives some more background information about the amendment.
ECHA has published an updated version of its Introductory Guidance on the CLP Regulation (version 3.0). The update takes into account the changes to the regulation brought by the latest Adaptations to Technical and Scientific Progress (ATPs), including the 12th ATP. Outdated information has also been deleted.

EU Falsified Medicines Directive
The final deadline of Commission Delegated Regulation (EU) 2016/161, which details the characteristics of the safety features, how medicine authenticity should be verified and by whom, is approaching fast. The delegated Regulation, and the new medicine verification system it lays down, will apply as of 9 February 2019. The European Commission has published its 13th version of the Questions and Answers document (677 kB) about safety features for medicinal products for human use.

Endocrine disruptors
On 7 November 2018, the European Commission published the report “Towards a comprehensive European Union framework on endocrine disruptors”. The report gives an overview of what endocrine disruptors are, what the EU policy has been in the past 20 years, and outlines a strategic approach to ensure a high level of protection of EU citizens and the environment and, at the same time, to preserve an internal market which delivers for consumers and where businesses can thrive.
Researchers from the Technical University of Denmark are partners in two new EU projects on hormone disrupting substances that aim to protect women's reproductive health and children's brain development. In total, the two Horizon 2020 projects have been allocated 12 million Euro. The National Food Institute has the biggest stake in both projects and will receive approximately one fifth of the funds. Both projects will commence in 2019 and run for five years. The National Food Institute conducts research into a large number of potentially harmful chemical substances and assesses the consequences with regard to food and consumer safety, with a particular focus on endocrine disruptors, cocktail effects and the development of QSAR models.

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