Non-food legislation - June 2019

27 June 2019

Packaging of medicine and medical devices
The new ASTM international standard F3375 aims to support the safety of liquid consumer products by testing restricted delivery devices (commonly known as “flow restrictors”) that help prevent children’s access. Safe Load Testing Technologies has published an overview article on medical device packaging standards.
The US FDA has published a new Guidance document on Unique Device Identification (UDI) for convenience kits. The FDA has also published a statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids.

Safety – Chemicals and nanomaterials
Food Packaging Forum reports that the OECD has published three new reports within their series titled “Safety of manufactured nanomaterials.”
In the ‘REACH Compliance’ research project, the BfR in collaboration with the Federal Environment Agency (UBA) examined the quality of registration dossiers in a comparison with the information requirements of REACH. ECHA has announced that improving compliance is ECHA's key priority. ECHA's free conference in May offered an insight into the current priorities for the regulation of chemicals in the EU. All the material is available on this page.
The European Union Chemical Legislation Finder (EUCLEF) is an upcoming online service that will enable companies to find out how their substances are being regulated in the EU and what legal obligations they have. Work is under way and ECHA is planning to launch the service in 2020.
On 12 June the European Commission opened a public consultation on a roadmap Fitness check on endocrine disruptors. The consultation is opened until 10 July 2019.
The European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) has announced the development of a Conceptual Framework for Polymer Risk Assessment (CF4Polymers). The framework (2.47 MB) reviews the state-of-the-science polymer grouping and risk assessment procedures and provides guiding principles for assessing potential ecological and human health hazards and risks from polymer products.
Food Packaging Forum informs about a call to stakeholders from China’s Solid Waste and Chemicals Management Center (MEPSCC) for data concerning 24 chemical substances. SGS has announced that Switzerland is proposing to align its chemical restrictions under ORRChem with those of EU REACH. If approved, the new restrictions will be implemented in phases starting 1 December 2019.
All products that consumers use in and around their homes contain chemical substances. At the same time, a wide range of information on chemicals is available. It is often difficult to distinguish the correct information from the nonsense. This information can now be found on the website waarzitwatin.nl (in Dutch), an initiative of the NL Ministry of Health, Welfare and Sport, RIVM (in Dutch) and VeiligheidNL.

Illicit cigarettes in the EU
The independent KPMG Stella Report, commissioned by PMI, reveals that in 2018 the black market for cigarettes in the EU cost governments a total of €10 billion in lost tax revenues. Overall illicit cigarette consumption levels remained stable compared to last year; however, the report found a more than 30% increase in counterfeit consumption—the largest amount recorded to date.


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