27 May 2016
Bisphenol A to be Further Restricted in Food Contact Materials and Certain Other Products
On 27 April 2016, it was reported that the European Food Safety Authority (EFSA) have established a working group of international experts to evaluate the toxicity of Bisphenol A (BPA) on the immune system. The decision to review BPA came after concerns were raised by the Dutch National Institute for Public Health and the Environment (RIVM) in relation to the possible toxic effects of BPA on the immune system of foetuses and young children. It is indicated that this review will take several months to complete.
It may be of interest to Hong Kong traders to learn that this investigation into BPA comes shortly after the World Trade Organization (WTO) published, on 14 March 2016, a notification from the European Union proposing a new regulation on the use of BPA in materials and articles in contact with food.
Hong Kong traders should take note of this development as it will directly affect manufacturers of plastic materials and exporters of foodstuffs to the EU. The proposed regulation will amend Regulation 10/2011, which permits the use of BPA in food contact materials in the EU. Regulation 10/2011 regulates plastics which are intended to come into contact with food, are already in contact with food, or might foreseeably come into contact with food.
Only substances included in Annex I of Regulation 10/2011, the so-called ‘Union list’ of authorised substances, may be intentionally used in the manufacture of plastic layers in plastic materials in articles. The Union list sets out: monomers or other starting substances; additives (excluding colorants); polymer production aids (excluding solvents); and macromolecules obtained from microbial fermentation.
BPA is used in the manufacture of polycarbonate plastic used in a wide range of products. These include electronic equipment, medical devices, CDs and DVDs, as well as food and drinks containers. The proposed regulation will cover plastics containing BPA that will ‘come in contact with food’.
Products that are considered “in contact with food” include self-adhesive plates such as film and foil; articles for the conveyance or packing of goods, of plastics, such as stoppers, lids, caps and other closures of plastics; and household articles, including tableware, kitchenware and toilet articles of plastics.
Hong Kong traders may recall that in January 2011, the European Commission adopted Directive 2011/8/EU prohibiting the use of BPA in the manufacture of polycarbonate infant feeding bottles. This decision to ban BPA followed an increase in public concern regarding the possible negative effects of BPA on human health.
The Commission, after new scientific data established a new Tolerable Daily Intake (TDI), has drafted the proposed regulation restricting BPA in food contact materials, to ensure the specific migration level (SML) is sufficient to protect human health and safety from the effects of BPA exposure. It is thought that BPA may have adverse effects on the kidneys and liver as well as being toxic to reproduction. Traders should bear in mind that the new TDI is temporary (t-TDI) and will be subject to further evaluation.
In light of the new t-TDI, the specific migration level (SML) needs to be reduced to ensure human exposure to BPA is below the t-TDI. The proposed regulation has introduced an SML of 0.05mg of BPA per kg of food. Under the current Regulation the SML is 0.6mg/kg. The proposed regulation also extends the SML of 0.05mg/kg to varnishes and coatings applied to materials and articles, where they have been produced using BPA.
The proposed regulation introduces a verification procedure to ensure compliance with the SML of products placed on the EU market. The procedure for verifying compliance is set out in already-established Regulation 10/2011.
The proposed regulation requires business operators to provide a written declaration of compliance at all stages of manufacture, processing and distribution (other than retail) containing the following information:
- the identity and address of the business operator issuing the declaration of compliance;
- the identity and address of the business operator which manufactures or imports the coated material or article;
- the identity of the laboratory responsible for testing;
- the identity of the varnished or coated material or article;
- the date of the declaration;
- confirmation that the varnish or coating applied to the material or article meets the SML; and
- specifications on the use of the coated material or article, such as which type or types of food it is intended to have contact with.
The written declaration must easily identify the varnished or coated materials and articles and it must be renewed to reflect any changes in migration levels.
In order to comply with the proposed regulation, business operators will have to ensure they can produce, upon the request of a national competent authority, the appropriate supporting documentation to demonstrate compliance with the written declaration such as test results, calculations and other analysis or evidence.
The proposed regulation is scheduled to be adopted in September this year and will enter into force 20 days after its publication in the Official Journal. However, the provisions will only become applicable 6 months after that date.
Furthermore, on 21 April 2016, the WTO published a notification from the European Union proposing to amend Annex XVII of the REACH Regulation in relation to BPA. The amendment will, it is intended, restrict the placing on the market of thermal paper containing BPA in a concentration equal to or greater than 0.02%.
The amendment was introduced to protect workers and consumers from BPA in thermal paper receipts.
According to the notification, the amendment is proposed to be adopted in the latter half of 2016 and will enter into force 20 days after its publication in the Official Journal. However, the restriction will apply three years thereafter. This transition period will allow manufacturers of thermal paper containing BPA sufficient time to amend their products and comply with the obligation.
The full text of the proposed Regulation can be accessed as follows:
Annex to Proposed Regulation