Non-food legislation - May 2019

29 May 2019

Packaging of medicine and medical devices
The Falsified Medicines Directive 2011/62/EU introduces harmonised European measures to fight medicine falsifications and ensure that medicines are safe and that the trade in medicines is rigorously controlled. The measures include obligatory safety features – a unique identifier and an anti-tampering device - on the outer packaging of medicines. Commission Delegated Regulation (EU) 2016/161 details the characteristics of the safety features, how medicine authenticity should be verified and by whom. The new medicine verification system applies as of 9th February 2019. Recently the EC published a document with questions and answers (698 kB) on the subject.
Both standards in the ISO 11607 series for packaging for terminally sterilized medical devices have been revised. ANSI has published an article about the changes made. ISO 11607-1:2019 addresses materials, sterile barrier systems, and packaging systems. ISO 11607-2:2019 covers the validation for forming, sealing and assembly processes.

Cosmetics: EU glossary of common ingredient names published
Newsletter Waar&Wet states that the rules for cosmetic products, including the labelling of ingredients, are laid down in Regulation (EC) 1223/2009 (consolidated version of 1 August 2018). The glossary of common ingredient names required by Article 33 of this Regulation has now been published by the European Commission: Commission Decision (EU) 2019/701. As of 8 May 2020 the common ingredient names are to be applied to cosmetic products placed on the market.

Hazardous substances
ECHA has announced the first report (4.67 MB) from its Integrated Regulatory Strategy. The report presents a mapping of the universe of registered substances that are on the EU market. This information helps authorities to identify, plan and monitor the progress on identifying and regulating substances of concern.
There are regular reports in the news about dumped drug waste. Because drug waste often consists of hazardous substances, it must be transported safely. Since it is not known which hazardous substances these are and it is therefore almost impossible to transport them completely according to the law, the Dutch Human Environment and Transport Inspectorate ILT (in Dutch) has written a work instruction for companies involved in the transport. The official version with accompanying letter can be downloaded here (in Dutch).

Tobacco products
Articles 15 and 16 of the Tobacco Products Directive 2014/40/EU (TPD) provide for EU-wide systems of traceability and security features for tobacco products to address the issue of illicit trade. The systems must be in place by 20 May 2019 for cigarettes and roll-your-own tobacco and 20 May 2024 for all other tobacco products. On 24 April 2019 the EC published a document with questions and answers (127 kB) on the subject.
Cigarettes and tobacco should be packaged in neutral packaging in the Netherlands from 2020. For cigars and e-cigarettes, it is envisaged that this will take effect in 2022. These measures are part of the National Prevention Programme (in Dutch). From 25 April to 26 May, an internet consultation (in Dutch) took place about the draft decision on standard packaging.

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