14 February, 2018, The European Commission has published its amending Regulation (EU) 2018/213 on the OJ to restrict the use of bisphenol A (BPA) in varnishes and coatings intended to come into contact with food. This regulation also amends the EU Food contact plastic Regulation (EU) No 10/2011 to further tighten the BPA migration limit. The regulation enters into force 20 days after its publication in the EU Official Journal and applies from 6 September, 2018.


Varnishes and coatings in the regulation refers to materials or articles consisting of one or more non-self-supporting layers in which BPA is used in order to endow the material or articles with a specific characteristic or to improve its technical performance.

According to (EU) 2018/213, the following requirements will apply for food contact varnishes and coatings:

1. The migration into or onto food of 2,2-bis(4-hydroxyphenyl)propane ('BPA') (CAS No 0000080-05-7) from varnishes or coatings applied to materials and articles shall not exceed a specific migration limit of 0.05 mg/kg.

2. No migration of BPA shall be permitted 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 in Regulation (EU) No 609/2013.

3. The relevant sections on detection limits, detection methods and simulacrum, test temperature, test time and result description in (EU) 10/2011 are also applicable to bisphenol A in varnishes and coatings.

4. Business operators shall ensure that varnished or coated materials and articles are accompanied by a written declaration of compliance. Business operators shall, upon request of a national competent authority, make available appropriate supporting documentation to demonstrate compliance with the written declaration not later than 10 days. The documentation shall contain the conditions and results of the testing, calculations, including modelling, other analysis and evidence on the safety or reasoning demonstrating compliance.

The revisions to (EU) 10/2011 in (EU) 2018/213 include: Specific migration limits for BPA from 0.6 mg/kg to 0.05 mg/kg. Also It is further clarified that BPA shall not be used in the production of polycarbonate baby bottles and drinking cups or bottles for infants and young children. Compared to the draft regulation of last August, the requirement for drinking glasses or bottles for infants and young children has been increased.

The amendments to Annex I of (EU) 10/2011 are as follows:

FCM No.

Ref No.

CAS No.

Substance

Specific migration

Restrictions and norms

151

13480

0000080-05-7

2,2-bis (4-hydroxyphenyl) propane

0.05mg/kg

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

"Infant" means a child under the age of 12 months; "young child" means a child aged between one and three years;

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.

With the further study and discovery of the hazard characteristic, action mechanism and exposure mode of BPA, the control of which in the world tends to be strict. In addition to the EU, the control of BPA in food contact materials and products in other countries includes but not limited to the following:

Country

Materials/Products

BPA Specific Migration Limits

Regulation/Standard Number

China

Paints and coatings

0.6mg/kg (applicable)

GB 4806.10

Plastic resins

0.6mg/kg (applicable)

GB 4806.6

Additives

0.6mg/kg (applicable For coatings and coatings)

GB 9685

America

Polycarbonate drinking utensils

1000mg/kg (Content requirement)

CA 65 Settlement Agreement

Japan

Polycarbonate plastic products

2.5μg/mL (migration)

500μg/g (content)

Food Sanitation Law of Japan

Korea

Polycarbonate, epoxy resin, polyaryl sulfone, polyaryl ester, organically coated metal products

0.6mg/kg

Standards and Specifications for Utensils, Containers and Packaging for Food Products

C&K Testing reminds enterprises to pay attention to the management and control dynamics of BPA, strengthen product quality control, and cooperate with the third party testing organization when necessary to obtain professional advice.



|Further Information:

Regulation (EU) 2018/213 on the Use of BPA in Varnishes and Coatings

|Our Service: