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Bisphenol A and European Legislation

Food packaging has been used since ancient time to transport, production, processing, storage, preparation and serving before its eventual consumption in safer way but due to technological development and addition of more and more materials in the manufacturing of packaging materials, it is essential to ensure that the materials using during the packaging materials and articles production, processing , storage, preparation and serving are not contacting with the food being packed in this packaging materials or before its eventual consumption. When food comes into contact with many materials and articles in direct or indirect way during its production, processing or storage, such materials and articles are called food contact materials (FCM).

Bisphenol A is also an important substance that often using in the varnishes and coating in the plastic food contact materials under European Regulation (EU) No 2018/213 and amending Regulation (EU) No 10/2011 that has been in force since 6 March 2018 and applies from 6 September 2018.

European Regulation (EU) No 2018/213, articles 6 states that “varnished or coated materials and articles or plastic materials and articles that were lawfully placed on the market before 6 September 2018 may remain on the market until the exhaustion of stocks.” Based on the discussion and understanding of the expert working group on food contact materials of the “ Standing Committee on Plants, Animals , Food and Feed ( PAFF), recommended that;

1. Regulation (EU) No 2018/213 concerns a restriction on the amount of BPA which is allowed to migrate from coating or varnish which has been manufactured using BPA, applied to food contact materials or articles. The articles 6 also describe the requirements on verification, declaration of compliance as well as supporting documentation.
2. Regulation (EU) No 2018/213, articles 2 laid down the specific migration limit (SML) in in the finished state and intended to be brought into contact with food or already in contact with food in order to verify compliance, while of Article 1(2) of Regulation (EC) No 1935/2004 included the intermediate materials and articles.
3. If a coating of food contact materials is unfinished, it may not be possible to verify compliance as the finishing of that layer can affect the migration of BPA or it might simply not be possible to perform a migration test. In addition to this, this regulation should not be considered to apply to the placing on the market of unfinished varnished or coated materials or to unfinished plastics. Therefore the Regulation including Article 6 only applies to varnishes and coatings in their finished state.
4. As a consequence of the reasoning developed above, once the varnish or coating has been applied to a secondary layer and no further processing is carried out that affects the physico-chemical properties of the varnish or coating itself and moreover the migration of BPA into food, the varnish or coating can be considered in its final state for the purposes of compliance with Regulation (EU) No 2018/213, including Article 6.
5. Further processing may be carried out in order to complete the manufacturing of the final materials and articles but which again, does not affect the physico-chemical properties of the varnish or coating itself or the migration of BPA into food.
6. The varnish or coating in its finished state may be considered as falling within the scope of "placing on the market" provided that it falls within the definition laid down in Article 2(1) (b) of Regulation (EC) No 1935/2004.

By

Dr. John David Nelson.