Regulatory information

BISPHENOL A

The legal framework governing the use of bisphenol A is becoming increasingly stringent.

Since June 2010, the manufacture and importation of baby bottles made from BPA has been banned in Europe (Regulation (EU) No 321/2011).

Regulation in France

In France, the national parliament has passed Law no. 2012-1442 of 24 December 2012, banning the use of bisphenol A (BPA) in packaging, containers or kitchen tools likely to come into contact with food, with effect from the 1st of January 2013 for food products for children under three years of age, and from 1st of January 2015 for the rest of the population. The full text of the law and the documents that led to its adoption can be viewed (in French) here: http://www.assemblee-nationale.fr/14/dossiers/conditionnement_alimentair...

 

Regulation in the EU

Bisphenol A has been identified by the Member State Committee as SVHC (Substance of Very High Concern) several times: on the 19th December 2016 because of its reprotoxic properties, on the 16th June 2017 for its endocrine disrupting properties for human health and on the 14th December  2017 for its endocrine disrupting properties for the environment.

For additional information: https://echa.europa.eu/-/member-state-committee-issues-four-svhc-agreements-and-two-opinions

https://echa.europa.eu/fr/-/msc-unanimously-agrees-that-bisphenol-a-is-an-endocrine-disruptor

https://echa.europa.eu/fr/registry-of-submitted-svhc-intentions/-/substance-rev/16117/term

In 2014, at the initiative of France, the Risk Assessment Committee (RAC) of ECHA (European Chemicals Agency) expressed its support for a stricter classification of bisphenol-A. ECHA then submitted its opinion to the European Commission, which voted in July 2016 for a more stringent classification of bisphenol A in the CLP (Classification, Labeling and Packaging Regulation ) by modifying its toxicity level from the category "suspected reprotoxic" (Category 2) to "presumed toxic for reproduction" (Category 1B). Registered on the 19 July 2016, this amendment will apply from the 1st of March 2018.

For more information: http://eur-lex.europa.eu/legal-content/FR/TXT/HTML/?uri=CELEX:32016R1179&from=EN

On 12th February 2018, the European Commission amended Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with foodstuffs: migration into or onto food of BPA from varnishes or coatings applied to materials and articles shall not exceed a specific migration limit of 0,05 mg of BPA per kg of food (mg/kg). This amendment will apply from 06 September 2018 (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R0213&from=FR).

In addition, a more restrictive regulation may be applied in European Union to other uses of bisphenol A

Following a proposal by France, the European Commission amended Annex XVII of Regulation: thermal papers (receipts, paper for facsimile fax ...) comprising more than 0.02% by weight of bisphenol A will not be placed on the European market. Dated 12th December 2016, the decision will come into force in January 2020.

To prevent an inappropriate substitution of BPA by BPS (which is suspected to have similar effects as BPA on human health), ECHA should carry out, among others actions, a survey in 2017 on the use of BPS in thermal papers. The Commission will then evaluate the need to propose a restriction of BPS in thermal papers.

For additional information: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R2235&from=FR

Moreover, the European Commission has amended the Annex II of the Directive 2009/48/EC on the safety of toys, including a migration limit of 0.04 mg / L for bisphenol A. Registered in July 2016, this amendment will apply from 2018.

For more information: https://echa.europa.eu/chemicals-in-our-life/hot-topics/bisphenol-a

 

OTHER BISPHENOLS

To date, the other bisphenols are not very well identified and mentioned in Regulations. For example, bisphenols F and S are not included in Annex VI to the CLP Regulation and therefore do not have harmonized labeling at EU level. In Europe, bisphenol S is allowed in plastics and articles intended to come into contact with food, with a migration rate of 0.05 mg / kg (Commission Regulation 10/2011). Other bisphenols are not mentioned in this Regulation and are therefore prohibited in plastics and articles intended to come into contact with food.

For more information: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:012:0001:0089:en:PDF

However, the European Commission requested the European Chemicals Agency (ECHA) to assess how bisphenol S is used as an alternative to bisphenol A and if it represents a risk to human health. If a risk is identified, the European Commission could request ECHA to prepare a restriction dossier under the REACH Regulation in order to ban Bisphenol S in thermal papers, which is conventionally used as alternative to BPA for this application.

For more information: https://echa.europa.eu/documents/10162/13641/echa_rest_proposals_rubber_granules_en.pdf

The above internet links were active as of June 22, 2017.

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