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Legislation

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BPA poised for classification as category 1 reprotoxin

Chemical Watch reports that the classification of bisphenol A (BPA) as a category 1B substance, toxic for reproduction, now looks a formality after it received the backing of EU member state officials last week.

Substances classified as category 1 carcinogens, mutagens or reprotoxicants are banned from use in consumer products in the EU.

They can also be nominated – according to REACH Article 57(a) – as a substance of very high concern (SVHC) and be added to the REACH candidate list.

However, it is possible that before that, or any other regulatory option is pursued, a member state may decide to first conduct a risk management option analysis (RMOA).

The proposed classification is included in the annex accompanying a draft Regulation setting out the ninth adaptation to technical progress (ATP) of the CLP Regulation. According to sources, last week’s meeting of the REACH Committee approved the draft with the BPA classification intact.

The European Commission will now send the draft Regulation to the European Parliament for scrutiny. This takes around three months. It will then return to the Commission for formal adoption and publication in the EU Official Journal.

The Regulation will enter into force 20 days after its publication. According to the draft text, it will apply 18 months after that date.

European Environmental Bureau (EEB) senior chemicals policy officer Tatiana Santos said the committee’s action was a “clear signal to take action to protect EU citizens from exposure to BPA”. Adding it to the candidate list would “rightly” make its phase-out a priority “given that it is a highly dangerous chemical that is impacting our health and that of future generations.”

BPA is manufactured in large volumes, primarily to produce polycarbonate and epoxy resins. According to Echa’s website, releases to the environment are “likely” from a wide range of products, including:

  • flooring;
  • furniture;
  • toys; construction materials;
  • footwear;
  • leather products;
  • paper and board; and
  • electronic equipment.

France has banned food contact materials containing BPA from its home market. The country's courts overtured a similar ban on the production and export of such materials last year

The REACH Committee is also due to consider a proposed restriction on the placing on the market of thermal paper containing BPA.

Among the registrants or suppliers of BPA listed on Echa’s website are major chemical companies 3M, BASF, DuPont, Henkel, Huntsman, Idemitsu, Kao, PPG, Sabic and Solvay.

EU food contact material rules under scrutiny

ENDS reports that MEPs and the European Commission are both examining how the EU’s patchy regulation of food contact materials (FCMs) could be improved, a European Parliament workshop heard on Tuesday.

The European Commission will receive a study from its Joint Research Centre in the coming weeks detailing the current situation with regard to regulation, including national regulation, of FCMs, an official said.

The study will also detail whether the principle of mutual recognition of product licences across member states is being respected, and examine which materials are not subject to detailed rules. Based on the report the Commission will decide whether there is a problem it needs to solve.

The EU’s 2004 framework regulation on FCMs sets out principles that apply to all materials that come into contact with food. Rules are set at EU level for plastic and recycled plastic FCMs but there are few EU rules for other materials, particularly paper and board. Where there are no EU rules the framework regulation empowers member states to adopt their own.

The Commission official noted that the plastic regulation ensures good functioning of the EU internal market but causes an enormous amount of work for industry, national regulators and the Commission because it is very detailed so requires constant updating.

A representative of the Swiss Food Safety Authority said there are around 100,000 substances that can migrate into food from FCMs, including both intentionally added substances and impurities. Only a fraction of these are regulated in the EU, meaning there is a major gap between the framework regulation’s ambition and reality.

MEP Christel Schaldemose (S&D), who is leading work on forthcoming European Parliament recommendations on food contact materials, said her report would tackle the gap between the legislation and the real level of risk assessment. She will recommend either better risk assessment or new regulation.

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