BISPHENOL A in food-contact applications: REGULATION (EU) 2018/213

Bisphenol A (2,2-bis(4-hydroxyphenyl) propane (BPA) (No CAS 80-05-7)) is a chemical substance widely used to manufacture materials for food contact. An example of material in which BPA is used is polycarbonate, which is rigid and durable and, therefore, it is used for articles intended to be reused, such as water dispensers, moulding equipment for confectionery products or, for example, for some kitchen utensils, such as beverage bottles or plastic containers. BPA is also used to manufacture coatings for food and beverage cans. However, BPA is not used to make flexible plastic packaging, such as those used to wrap foods or for single-use water bottles.

EU Regulation 10/2011 on plastic materials and objects intended to come into contact with food has undergone different modifications since its entry into force. The last one, affecting BPA, was published last 12 February and will be applicable from 6 September 2018.

This modification affects the use of bisphenol A in varnishes and coatings intended to come into contact with food and amends annex I of Regulation (EU) 10/2011 as regards the use of that substance in plastic food contact materials.

The main changes are:

• The migration of BPA from plastic materials and articles shall not exceed a specific migration limit of 0.05 mg of BPA per kg of food (mg/kg). BPA shall not be used in the manufacture of polycarbonate feeding bottles for infants and shall not be used in the manufacture of polycarbonate cups or feeding bottles that, due to their anti-spill characteristics, are intended for infants and young children.
• The migration of BPA from varnishes and coatings applied to materials or articles shall not exceed a specific migration limit of 0.05 mg of BPA per kg of food (mg/kg) and the migration of BPA from varnishes or coatings applied to materials and articles specifically intended to come into contact with prepared food, foodstuff and beverages intended for infants and young children will not be allowed.

In order to verify the compliance, if it is necessary to perform tests, both for plastic materials and objects, and for varnishes and coatings applied to materials or objects, the specific migration tests and the expression of results will be performed according to the standards established in the Regulation 10/2011.

Once verified the compliance, business operators shall ensure that plastic materials and articles, and varnished or coated materials and articles are accompanied by a declaration of compliance. The declaration shall be available at all stages of manufacture, processing and distribution different from retailing.

Although the Regulation will enter into force on 6 September 2018, varnished or coated materials and articles and plastic materials and articles that were lawfully placed on the market before 6 September 2018 can remain on the market until exhaustion of stocks.

Since BPA is a substance of concern, this last modification will be followed by a new full re-evaluation of BPA. It is a work that the European Commission has ordered to EFSA (European Food Safety Authority), which will begin in the spring of 2018 and once completed, the Commission will evaluate the results and will decide what further measures are necessary to protect consumers with regard to BPA in food contact materials.

AIMPLAS has the analytical capacity to determine BPA, both residual content and specific migration, even for the new specific migration limit required.