January 27, 2021

Volume XI, Number 27

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UK Announces Procedure for Authorization of New FCMs

The United Kingdom (UK) has issued a guidance on authorizing food contact materials (FCMs) now that it has exited from the European Union (EU). The Food contact materials authorisation guidance, published by UK's Food Standards Agency on December 31, 2020, outlines the procedure for authorizing new FCMs to be placed on the market in Great Britain (GB).*

The guidance refers to several retained EU regulations and a directive (shown below) and points out that:

"For most regulated product types, once products or processes are authorised, they are listed in relevant legislation, which also sets out how they can be used. These lists are referred to as positive lists."

Food contact substances on the positive lists under the Plastics Regulation and the Directive for regenerated cellulose film that were authorized by the European Commission (EC) before January 1, 2021, will not need to be reauthorized by UK authorities to be placed on the market in GB. However, if a FCM application was submitted to EU authorities before January 1, 2021, and the applications process has not been completed (e.g., a petitioned monomer/additive has not yet added to the Plastics Regulation (EU) No. 10/2011 by that date), then a new application will need to be submitted to the UK Food Standards Agency. If a European Food Safety Authority (EFSA) opinion was published for that food contact substance, then the submitter should include the EFSA question number when completing the application form for authorization in GB.

Since positive lists for active/intelligent materials and recycled plastics have not been established in EU legislation, these products may be placed on the market in GB if they meet the requirements of GB's General Food Law Regulations and any general criteria in FCM legislation.

The guidance explains how to apply for authorization of new FCMs. Concerning the development of dossiers, the detailed guidance previously developed by EFSA remains relevant since the GB approach is based on EU processes. UK authorities foresee that their risk assessment (safety evaluation of a substance) and risk management (publication of an amendment to the GB legislation, i.e., the retained EU law) will take up to 15 months.

*Even though Northern Ireland is part of the UK, the procedure for new authorizations for FCMs to be placed on the market in Northern Ireland will continue to follow EU rules based on the requirements in the Northern Ireland Protocol, which is part of the EU-UK Withdrawal Agreement of October 17, 2019.

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© 2020 Keller and Heckman LLPNational Law Review, Volume XI, Number 13
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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