Relevant for: Hardlines, Toys & children's products
Back in September 2017, we brought to your attention the proposal1 to amend the bisphenol A (BPA) requirements under Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food2. Since then, details of the proposal had been changed and the final changes have now been published in the Official Journal of the European Union on 14 February 2018 as Regulation (EU) No 2018/2133 (to be referred to as „the Regulation“ in this article).
The Regulation tightens or introduces new measures on the following two uses of BPA:
- As a monomer in the production of plastic materials and articles intended to come into contact with food, such as polycarbonate plastic; and
- In epoxy resins used in varnishes and coatings.
Table 1 below compares the new requirements with the current ones. The new requirements will begin to apply from 6 September 2018.
Table 1. A comparison of the current requirements on BPA under Regulation (EU) 10/2011 with the new amendments in Regulation (EU) 2018/213.
Regulation (EU) 10/2011
Regulation (EU) 2018/213
(effective from 6 September 2018)
Restrictions and specifications
|Not to be used for the manufacture of polycarbonate infant feeding bottles.|
Not to be used for the manufacture of polycarbonate infant feeding bottles.
Not to be used for the manufacture of polycarbonate drinking cups or bottles which, due to their spill proof characteristics, are intended for infants and young children.
SML (mg/kg) from:
(1) plastic materials
(2) varnishes or coatings applied to materials and articles
No migration from varnishes or coatings applied to materials and articles specifically intended to come into contact with infant formula, follow-on formula, processed cereal-based food, baby food, food for special medical purposes developed to satisfy the nutritional requirements of infants and young children or milk-based drinks and similar products specifically intended for young children, as referred to in Regulation (EU) No 609/20134.
In addition, business operators have to ensure that varnished or coated materials and articles are accompanied by a written declaration of compliance (DoC) as in accordance with Article 16 (1) of Regulation (EC) No 1935/20045. Details of the information to be included in the DoC are as follows:
1. the identity and address of the business operator issuing the declaration of compliance;
2. the identity and address of the business operator which manufactures or imports the coated material or article;
3. the identity of the varnished or coated material or article;
4. the date of the declaration;
5. confirmation that the varnish or coating applied to the material or article meets the restrictions laid down in Article 2 of this Regulation and the requirements set out in Articles 3, 15 and 17 of Regulation (EC) No 1935/2004;
6. specifications on the use of the coated materials or articles, such as:
- the type or types of food with which it is intended to be put into contact;
- the time and temperature of treatment and storage in contact with food;
- the highest food contact surface area to volume ratio for which compliance has been verified in accordance with Article 17 and 18 of Regulation (EU) No 10/2011 or equivalent information.
The declaration shall be available at all stages of manufacture, processing and distribution other than the retail stage. Upon request of national surveillance authorities, all supporting documentation to demonstrate compliance has to be provided within 10 days.
Varnished or coated materials and articles and plastic materials and articles that were lawfully placed on the market before 6 September 2018 may remain on the market until exhaustion of stocks.
The substance 2,2-bis(4-hydroxyphenyl)propane (CAS 80-05-7), commonly known as bisphenol A (BPA) is used in the manufacture of certain materials and articles intended to come into contact with food, such as polycarbonate plastic and epoxy resins used in varnishes and coatings. BPA can migrate into food from the material or article with which it is in contact, resulting in exposure to BPA for consumers of those foods.