Plastics and articles thereof (HS code(s): 39); Rubber and articles thereof (HS code(s): 40); Materials and articles in contact with foodstuffs (ICS code(s): 67.250)

Public Health Protection Notice (Food) Order (Adoption of Regulation 2024/3190 – Use of Bisphenols in Certain Materials and Articles Intended to Come into Contact with Food), 5786–2026. Language(s): Hebrew. Number of pages: 8

The existing arrangement in Israel regarding the use of Bisphenol A (BPA) in food contact materials is based on the adoption of Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (hereinafter – Regulation 10/2011), which was adopted in Israel under Amendment No. 10 to the Public Health Protection (Food) Law, 5776–2015 (hereinafter – the Law / the Food Law), and appears in Item 16 of Annex II A to the Law.

Following an updated scientific assessment by the European Food Safety Authority (EFSA), published in 2023, it was determined that dietary exposure to BPA poses a health concern for all population groups, even at exposure levels significantly lower than the threshold previously established. Accordingly, the European Commission adopted Commission Regulation (EU) No 2024/3190 of 19 December 2024, which repeals the arrangement applicable to BPA and additional bisphenols under Regulation 10/2011 (hereinafter – Regulation 2024/3190). Regulation 2024/3190 establishes a general prohibition on the use of BPA and additional bisphenols classified as having hazardous properties, in materials and articles intended to come into contact with food, alongside narrow exceptions for essential and defined uses, subject to the condition that no migration into food occurs, as was the practice under Regulation 10/2011. In addition, a uniform mechanism has been established for applying the prohibition also to bisphenols and their derivatives bearing a hazardous harmonised classification, in order to prevent the substitution of BPA with substances having a similar risk profile. Regulation 2024/3190 includes graduated transitional provisions, designed to allow food business operators and the supply chain to prepare, without compromising food safety or continuity of supply.

It is proposed to adopt this Regulation with exclusions, as they appeared in Column A of Item 16 (Regulation 10/2011) of the Annex II A to the Law, in addition to the exclusions set out in Section 3A(a1)–(a5) of the Law, as well as a number of additional exclusions in Columns B and C of that Schedule. Accordingly, it is proposed that this Regulation shall apply in Israel solely with respect to the following:

(a)  A proper importer importing food through the European track;

(b)  A manufacturer holding a proper manufacturing approval or a manufacturer holding a commitment submission approval, in whom the provisions of Section 321A of this Law are fulfilled;

(c)  A distributor who purchased or received food from those referred to in paragraphs (a) or (b).

In light of the foregoing, it is proposed to adopt in this Order the provisions of Commission Regulation (EU) No 2024/3190, in order to maintain a high level of protection of public health, to ensure risk-based and up-to-date regulation, and to preserve regulatory alignment with the European Union in the field of food contact materials. It is further proposed to amend, by a separate ministerial order, Regulation 10/2011 as adopted in Israel under Amendment No. 10 to the Law in August 2024.