COMMISSION REGULATION (EU) …/…
of XXX
on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC 1 , and in particular points (d), (e), (h), (i) and (j) of Article 5(1) thereof,
Whereas:
(1)The substance 2,2-bis(4-hydroxyphenyl)propane (CAS 0000080-05-7), 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.
(2)The use of BPA as a monomer in the production of plastic materials and articles is authorised by Commission Regulation (EU) No 10/2011 2 . The authorisation is subject to a specific migration limit (SML) of 0.6 mg of BPA per kg of food (mg/kg) based on a previous evaluation by the Scientific Committee on Food 3 . The European Food Safety Authority (the Authority) has reviewed scientific information and updated its opinion on BPA in 2006 4 , 2008 5 , 2010 6 and 2011 7 . A prohibition is in place on its use in the manufacture of polycarbonate infant feeding bottles on the basis of the precautionary principle.
(3)After the publication of its scientific advice on BPA in 2011, the Authority noted that its exposure assessment which dated back to its 2006 opinion needed to be updated in light of new data and that the relevance of dietary exposure in the context of other routes of exposure should also be investigated. The Authority decided to undertake a full re-evaluation of BPA based on the most recent scientific evidence. In 2012, in accordance with Article 29(1)(b) of Regulation (EC) No 178/2002 of the European Parliament and of the Council 8 , the Authority asked its scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) to provide a scientific opinion on the risks to public health related to the presence of BPA in foodstuffs.
(4)The Authority adopted an opinion on 11 December 2014 9 , having reviewed the available data and scientific studies published from 2006 to 2012 as well as some studies available in 2013. In that opinion, the Authority established changes in mean relative kidney weight in a two-generation study in mice as the critical endpoint and calculated a Benchmark Dose (Lower Confidence Limit) (BMDL10) of 8960 µg/kg bw per day. It was able to apply new toxicokinetic data to allow a more accurate substance-specific extrapolation of data from animals to humans and established a human equivalent dose (HED) of 609 µg/kg bw per day. The HED was used as a reference point for establishing a health-based guidance value for BPA.
(5)To establish this health-based guidance value, the Authority applied an uncertainty factor of 2.5 for inter-species differences and 10 for intra-species differences. It applied an additional factor of 6 to take into account uncertainties surrounding potential health effects of BPA on the mammary gland, reproductive, metabolic, neurobehavioural and immune systems. As a result, an overall uncertainty factor of 150 was applied to establish a new Tolerable Daily Intake (TDI) of 4 µg/kg bw per day. However, the Authority designated the TDI as temporary (t-TDI) pending the anticipated outcome of a long-term toxicity study on BPA in rodents being undertaken by the National Toxicology Program/ Food and Drug Administration (NTP/ FDA) in the United States of America (USA).
(6)The Authority noted that dietary exposure to BPA is below the t-TDI and concluded that there is no health concern at the estimated levels of exposure. In its opinion adopted on 11 December 2014 the Authority also estimated non-dietary sources of exposure as well as those from the diet. Non-dietary sources include exposure through air, ingestion of dust and uptake through the skin as a result of contact with thermal paper and cosmetics. The Panel concluded that the central estimates for aggregated exposure to BPA through dietary and non-dietary sources for the highest exposed groups including infants, children and adolescents, are below the t-TDI and that the health concern for BPA is low at the estimated levels of aggregated exposure.
(7)Following the opinion published by the Authority in 2014, the current SML for plastic materials and articles should be updated to take account of the new t-TDI. The setting of the SML uses a conventional exposure assumption that 1 kg of food is consumed daily by a person of 60 kg body weight and that all exposure comes from food contact materials. Article 5(1)(e) of Regulation (EC) No 1935/2004 establishes that specific limits on the migration of certain constituents into or onto food should take due account of other possible sources of exposure to those constituents. The Authority noted that exposure from non-dietary sources of BPA may contribute a significant proportion of overall exposure for some population groups and that in addition to these non-dietary sources, non-canned meat and meat products were found to be a major contributor to BPA exposure for several population groups. In such cases where sources other than food contact materials may contribute significantly to the potential overall exposure of a substance, it is not appropriate to allocate the full TDI to food contact materials and a lower value should be used.
(8)Taking into account conventional assumptions on the use of allocation factors for food contact materials, including that the overall exposure does not exceed the t-TDI and the uncertainty factor of 150 in the derivation of the t-TDI, as well as the data in the Authority's opinion on sources of BPA other than food contact materials, an allocation factor of 20% is considered appropriate when setting the SML. Therefore, on the basis of the t-TDI, the allocation factor and the exposure assumption, an SML of 0,05 mg of BPA per kg of food (mg/kg) should be set for plastic materials and articles to ensure that exposure to BPA remains below the t-TDI and does not endanger human health.
(9)While the SML established, which takes into account the opinion, serves as a basis for the overall management of risks posed by BPA from food contact materials, there are still uncertainties, which are identified in that opinion. With respect to two new studies on the developmental immunotoxicity of BPA, the Authority stated in 2016 10 that the new evidence presented by those studies adds to the indications of developmental immunotoxicity of BPA. Taking into account the extent of the scientific uncertainties and the nature of the potential adverse effects, in particular developmental effects, further precautionary steps should be taken as regards more vulnerable population groups, in particular infants and young children, where developmental effects could be irreversible and would last a life-time.
(10)The precautionary principle referred to in Article 7 of Regulation (EC) No 178/2002 authorises the adoption of provisional measures on the basis of available pertinent information, pending results related to continued uncertainties, to an additional assessment of risk and a review of the measure within a reasonable period of time.
(11)The Commission is authorised to take preventive measures as regards the use of BPA on the basis of the precautionary principle which is applicable in a situation in which there is scientific uncertainty, even if the risk, notably to human health, has not yet been fully demonstrated. In order to do so, BPA should not migrate from plastic materials and articles specifically intended to come into contact with food intended for infants and young children as referred to in Regulation (EU) No 609/2013 of the European Parliament and of the Council 11 , namely infant formula, follow-on formula, processed cereal-based food, baby food or food for special medical purposes developed to satisfy the nutritional requirements of infants and young children.