Non-food legislation - August 2019

05 September 2019

REACH and other regulations for chemicals
The UNECE has published the 8th revision of the Globally Harmonized System of classification and labelling of chemicals (GHS). The EU Union Observatory for Nanomaterials (EUON) has published a database of nanomaterials known to be currently on the EU market. The EUON has also published the results of a mid-term review to evaluate how it has met its objective of giving reliable information on the markets and safety aspects of nanomaterials in the EU.
On 24 June, the EC published a report titled “Chemicals Innovation Action Agenda: Transition to Safer Chemicals and Technologies,” which reviews the efforts of “frontrunner companies” to substitute substances of concern out of their supply chain. On the same day ECHA announced that it will start to evaluate 20% of registration dossiers in each tonnage band to improve the compliance of REACH registrations. This will mean that approximately 30% of all registered chemicals will be checked.
On 25 June the EC published a report presenting “Findings of the Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses.” The results were discussed during the conference 'EU Chemicals Policy 2030'. ECHA also published the report (1.68 MB) “Downstream users’ information needs under REACH.” The EC published Regulation (EU) 2019/1021 on persistent organic pollutants (POPs) in the OJ. On 26 June, Cefic launched an Action Plan to help REACH registrants review chemical safety data and the EU Council adopted conclusions (335 kB) on chemicals which offer political guidance on the development of a sustainable policy strategy. The conclusions address in particular the topics of REACH, endocrine disruptors, nanomaterials and pharmaceuticals. On 10 July, ECHA announced the submission of a recommendation to the EC to amend Authorisation List (Annex XIV of REACH) entries by adding the endocrine disrupting properties of four phthalates: DEHP, BBP, DBP and DIBP.

EU project AskREACH
The EU project AskREACH published a report (3.42 MB) on information sharing about the presence of substances of very high concern (SVHCs) in articles. The survey shows that Europeans are highly concerned about the presence of problematic chemicals in articles. AskREACH has developed an EU database for suppliers to submit information on SVHCs in their articles. A smartphone app will be launched in October 2019, allowing consumers to access the information in the database and make SVHC requests for articles not found in the database.

Packaging for pharmaceutical products
EU: The EC has published the document (703 kB) “Questions and answers (version 15) - Safety features for medicinal products for human use.” GS1 has recently been designated by the EC as issuing entity for Unique Device Identifiers (UDIs). NL: In June, the House of Representatives adopted a motion (in Dutch) on making the packaging of medicines more accessible and in July Minister Bruins reported (in Dutch) on a number of matters relating to (the prevention of) medicine waste. US: The FDA has published two draft guidance documents on medication and biological product labelling. One is on conveying important information related to abuse and dependence and the other is about the Instructions for Use (IFU).

Plain packaging for tobacco products
The Belgian government has decided (in Dutch) that, from 1 January 2020, packaging for tobacco products will all have the same green-brown colour. This decision has also been taken in the Netherlands, with 1 July 2020 as the starting date. In an article (966 kB) published in Marketing Science, researchers at Deakin University look at the sales impact of the plain packaging regulation in Australia.

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