News from the National Key Laboratory for Testing of Food Contact Materials (Guangdong) IQTC, on August 4, the European Commission issued the “Risk Management of Bisphenol A (BPA) and Other Bisphenol Substances in Food Contact Materials” Questions and Answers on Methods”, the European Commission proposes to ban the intentional use of bisphenol A in food contact materials.
1. Prohibition
The European Commission proposes to ban the intentional use of bisphenol A in food contact materials. The proposed ban involves the intentional use of BPA as a substance in the manufacture of food contact materials, such as in plastics or coatings. The ban will put bisphenol A (FCM)
151) Removed from the authorization list in Annex I of (EU) No 10/2011.
2. Implementation time
The ban is expected to take effect in the spring of 2024, and after an 18-month transition period, bisphenol A will be officially banned from being used in food contact materials at the end of 2025 or early 2026.
The information feedback period ends on September 15, 2023. Feedback can be sent to the email: SANTE-FCM-CONSULTATIONS@ec.europa.eu
3. Risk assessment basis
In a scientific opinion released on April 19, the European Food Safety Authority EFSA established a new tolerable daily intake (TDI) of bisphenol A at 0.2ng/kg
bw/d, and concluded that dietary exposure to BPA can cause health problems. Because the TDI is too low, control via SML cannot continue.
4. Scope of application
All food contact materials and articles on the EU market that may be manufactured using bisphenol A, including plastics, coatings, adhesives, printing inks and rubber. The ban does not include materials that do not themselves use BPA, such as wood and glass.
The ban also applies to food contact materials and articles exported to the EU, including food packaging, kitchenware, tableware and food processing equipment. However, drinking water materials do not fall under (EC) No 1935/2004
Scope of regulations.
5. Can bisphenol A be used on non-food contact surfaces?
Regulation (EC) No 1935/2004 on which this measure is based
The scope includes “those intended to come into contact with food; those that have come into contact with food and have previously done so; those that have reason to believe that they will come into contact with food, or that their constituents will migrate into food under normal or foreseeable conditions of use.” Materials and Articles”.
For example, the outer coating of metal packaging, metal materials are considered bisphenol A
There is an absolute barrier that cannot be passed, but substances from the outer coating may be transferred in small amounts through the gas phase to the inside of the can and thus migrate into the food. Physical contact (such as stacking) between the inside and outside of food contact materials may also cause similar transfer. In this case, the outer layer of the metal can may be interpreted as a food contact material.
6. How to prove compliance and how to distinguish intentional use from accidental contamination?
Convey compliance through a Declaration of Conformity (DoC). If the DoC states that bisphenol A is not used, but sampling analysis by the competent authority shows that bisphenol A is present, the business operator should cooperate with the competent authority of the member state to conduct further investigation? Conduct further investigations to determine the source of BPA and take control measures.
7. What rules apply to the accidental presence of bisphenol A?
Although the measure no longer allows the intentional use of BPA in food contact materials, residual BPA may still be present in food contact materials, such as some recycled contaminated food contact materials, such as plastics, paper and cardboard. This incidental presence of BPA will not be subject to the ban, but its content will need to be detected so that subsequent investigations can be used to determine the source and control measures.
8. Impact on recycled plastics used for food contact
(EU) 2022/1616 applies to recycled plastic materials and articles intended to come into contact with food. It only allows recycling of plastics that comply with (EU) No 10/2011. Bisphenol A from (EU) No
10/2011 After deletion from Annex I, plastic materials and articles (e.g. polycarbonate) made using bisphenol A will no longer be recyclable.
9. How to regulate bisphenol A analogues
The European Commission considers that the use of bisphenols with similar or other specific hazardous properties as a substitute for bisphenol A should be avoided unless their use is deemed necessary and supported by an up-to-date risk assessment to demonstrate that their limited use remains safe . Although the European Food Agency’s scientific opinion only concerns bisphenol A, what about bisphenol and its derivatives? Right thing? Health-like damage showing similar? reproductive toxicity and endocrine potential? interference (ED) characteristics. Predictable? The measures will also cover other bisphenols known to have such specific hazardous properties.
Recently, the European Chemicals Agency ECHA and EU member states have evaluated 148 bisphenols and recommended restricting the use of more than 30 bisphenols because of their possible effects on human health and the environment. Risk data for an additional 22 bisphenols are also being assessed.
10. How to regulate bisphenol A-diglycidyl ether (BADGE)?
The ban is intended to apply to the intentional use of BPA as a substance in the manufacture of food contact materials to limit its presence and potential migration into food. Bisphenol A-diglycidyl ether (BADGE) (CAS
1675-54-3) has undergone an individual risk assessment and is regulated under (EC) No 1895/2005. REACH is also currently evaluating the safety of BADGE.
11. How to apply for a longer transition period?
If business operators believe that the 18-month transition period encounters major problems, they can apply for a longer transition period, including the following reasons:
1) Impact on food safety, such as microbial and chemical contamination;
2) Impact on food security, food waste and supply chain;
3) The impact of additional resources, including costs;
4) Lack of directly available alternatives, including alternative packaging or food production systems;
5) The development status of alternatives and the reasonable additional time required;
6) Typical migration levels of bisphenol A in relevant materials.
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