EU Regulatory Bulletin contents
- BPR Adopted
- Pesticides Update
- ECHA & Information disclosure
- REACH scope review
- BPA Developments
- Antitrust Manual
The regulatory landscape is changing rapidly for manufacturers and users of Bisphenol A (BPA), a substance allegedly susceptible to have endocrine disruption properties. In 2013, a ban on certain uses will roll out in several EU jurisdictions, with a focus on food and children applications, similar to the measures already passed in e.g. Canada and California. A roundup of latest developments in the EU is provided below.
On 24 April 2012, the European Food Safety Authority (EFSA) announced that it has started work on a new risk assessment of BPA used in food contact materials (such as packaging and containers, kitchen equipment, cutlery and dishes), focusing specifically on its exposure to vulnerable groups. EFSA claims that this initiative was taken in light of its ongoing monitoring of scientific research on BPA and EFSA's Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)’s further consideration of new scientific studies – and would thus be unrelated to various initiatives in the Member States of the EU (see below).
Following observations of some BPA-related effects in rodents at low dose levels, uncertainty has grown about the possible relevance to human health. EFSA will tackle the issue of low dose effects in toxicology and risk assessment at its 17th Scientific Colloquium to be held in Parma on 14-15 June 2012. According to the so-called “low dose-hypothesis”, hormonally active agents may exert “low dose effects”, which would challenge the assumption in the current risk assessment process for most chemicals that the individual response of an organism to a chemical substance increases proportionally to the exposure/dose. Several chemicals that can be present in food have been claimed to possess endocrine active properties and to produce “low dose effects”. These include several pesticides, dioxins, polychlorobiphenyls (PCBs), and bisphenol A.
According to its current work plan, CEF will provide a full re-evaluation of the human risks associated with exposure to BPA through the diet by May 2013, to complement its earlier opinion. EFSA say the experts in CEF will take into consideration new findings from ongoing studies on low dose effects as well as on dietary and non-dietary exposure to BPA as they become available during 2012.
EFSA is encouraging the input of the EU Member States, calling for data to provide an up-to-date indication of the occurrence of BPA in food, as well as the amount of BPA residue that migrates from food contact materials into food, and inviting experts from national authorities undertaking related scientific work on BPA to contribute to two multidisciplinary working groups of experts established to focus on the hazard characterisation of BPA and exposure to BPA. The agency also noted it will liaise with scientific experts in Member States and in the US on risk assessment reports in preparation, and on large-scale studies currently in progress.
On 12 April 2012, the Swedish environment ministry proposed a national ban on the use of coatings and linings containing BPA in packaging for food intended for children under the age of three. Sweden hopes national legislation could come into force as early as 1 January 2013.
Sweden is also intending to raise the issue with the Commission and other Member States in order to persuade the EU to bring in similar measures at Community level, just as it was able to do with polycarbonate baby bottles.
The Swedish environment ministry has also given the Swedish Chemicals Agency (KemI) three months to investigate the feasibility of banning the use of BPA in thermal paper and till receipts. However, a similar assessment for the Danish environment ministry last year concluded that this does not pose a significant health risk to consumers.
In addition, KemI will assess the extent to which BPA is used in coatings used to reline existing water pipes, as well as in toys and childcare articles, and the rate at which BPA can leach out of such products.
On March 6 2012, the German Environment Agency (UBA) issued a statement on plans to assess BPA for endocrine disrupting properties, with a view to regulating its use if it is proved a harmful substance. The assessment will take place under the EU Community Rolling Action Plan (CoRAP), under which total of 36 chemicals will be evaluated in 2012 alone, pursuant to Articles 44 to 48 of REACH (Regulation (EC) No 1907/2006).
The risk to human health will be assessed by the Federal Institute of Risk Assessment (BfR) and the Federal Institute for Occupational Safety and Health (Baua). The environmental assessment will be carried out by UBA.
Belgium bans BPA in food containers for young children
Belgium implemented the EU baby bottle Directive 2011/8 through the Royal Decree of 10th of February 2011. The Belgian legislator decided to take a step further and decided to draft an overall BPA ban. In November 2010 , the Belgian Superior health Council released an Opinion, referring to most of the opinions published by the various national authorities involved in food safety, which indicated that the exposure of the general public, including young children, to BPA did not seem a cause for concern in terms of health. Taking into account the uncertainties on the toxicity of BPA, the Council however recommended, based on the precautionary principle, that the exposure of young children to BPA should be limited to as low a level as possible.
The Belgian legislator considered that, as long as the national Superior Health Council did not deliver a new and more conclusive opinion on the overall human BPA exposure risks, it was premature to impose a total ban, notably in times of economic crisis. Therefore the scope of the proposal was reduced to a ban on the placing on the market and manufacturing of containers of foodstuffs intended for children of up to 3 years old and which contain BPA.
The ban is planned to become effective as of 1 January 2013. As a measure having a possible impact on free movement in the internal market, the text was notified on 1 March 2012 to the European Commission.
France rolls out its BPA ban
In the November 2011 EU Regulatory Bulletin we reported that the French parliament approved a draft law seeking the suspension of the manufacture, import, export and placing on the market of packaging containing BPA. Some Member States (allegedly including the UK, the Netherlands, Italy and Spain) raised concerns about the creation of unjustified barriers between EU member states. It should be stressed that imports from the US and other third countries would also be banned, potentially in breach of WTO rules. The Commission, awaiting an Opinion from EFSA, did meanwhile not oppose the ban.
The suspension of the use of BPA is intended to apply as of 1 January 2014 to materials and articles intended to contain foodstuffs, as well as to the food itself. The suspension will be effective as early as 1 January 2013 if such packaging, containers and utensils are intended for use with foodstuffs for infants and young children. In anticipation of the cessation of the use of BPA, the law states that the same materials and objects shall be labelled with a health warning advising against their use by pregnant women and children under 3 years old.
ANSES (the French National Agency for Food Safety, Environment and Labour) should soon publish an overview on the comments received on the September 2011 report and indicated that it will release in the last quarter of 2012 a progress report on substitute products for BPA, as well as their safety and suitability for use in the manufacture of plastics and resins for foodstuffs.
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