The Helsinki-based European Chemical Agency (ECHA) triggered in mid-January moves which could place restrictions on or even the phasing out of the use of bisphenol A (BPA).
The agency, which is responsible for the implementation of the European Union’s main industrial chemicals legislation, is already assessing a proposal that titanium dioxide be categorized as a dangerous chemical. This is because TiO2 dust has been classed as being possibly carcinogenic.
Then there is a threat that two essential coatings biocides – formaldehyde releasers and isothiazolinone – may fail a safety review under the EU’s new Biocides Products Regulation (BPR). This requires far more rigorous and costly safety data to be submitted than under the previous EU’s biocides legislation.
Although BPA in the coatings sector is effectively only an intermediate used mainly to harden epoxy resins, the chemical is nonetheless a crucial ingredient to producers of can and some other protective coatings.
“It is an important building block in coatings formulations which acts as a cross-linker and provides highly effective chemicals resistance,” explained Janice Robinson, director of product regulations at the European Council of Paint, Printing Ink and Artists’ Colours Industry (CEPE).
BPA is one of four new additions to the Candidate List of substances of very high concern (SVHC) announced by the ECHA after proposals for measures against the chemicals were proposed by France, Sweden, Germany and Austria.
Under the EU’s core chemicals legislation REACH – Registration, Evaluation, Authorisation and Restriction of Chemicals – substances on the Candidate List could need to be given authorization to stay on the market and even then for only a limited period until safer substitutes have been developed.
Alternatively they could be subject to restrictions such as curbs on the way they are used or on their range of applications.
The latest selection of four Candidate chemicals brings the total on the list to 173 substances some of which have been on it for several years. But BPA may be prioritized for authorization or restrictions because it is a relatively high volume product with a global capacity of 2-2.5 million tons. Also being regarded by scientists and NGOs as a major hazard, particularly since it is seen as an endocrine or hormone disruptor, its safety has caused considerable debate since the 1990s.
Its addition to the Candidate List has immediate implications for coatings producers, their raw materials supplier and coatings purchasers.
Suppliers of articles or finished products which contain substances on the Candidate List in a concentration above 0.1 percent by weight have to provide information to their customers to allow “safe use of the article,” according to the REACH regulation.
Consumers buying the article can also request information on safe use with the supplier having to respond within 45 days.
Producers or importers of finished products have to notify ECHA if their articles contains a substance on the Candidate List. This obligation applies if the substance is present in the articles in quantities totaling over one ton per producer or importer per year and the substance is present in the finished product above a concentration of 0.1 percent by weight.
For coatings producers a big concern is the response of downstream customers or end-users to the inclusion of the BPA on the List. Recently when other chemicals have been placed on the List brand owners and retail chains have been reluctant to have them in their products.
The German Federal Institute for Occupational Safety and Health (BAuA), which has been acting as rapporteur for BPA assessments for ECHA, is at present drawing up a dossier with recommendations of either authorisation or restrictions on the chemical. Under REACH, this is called a risk management option analysis (RMOA).
The dossier will be examined by the agency’s risk assessment committee (RAC) of experts from the EU’s member states to make proposals for a final decision by the European Commission, the EU’s Brussels-based executive.
BAuA has sent round a questionnaire to coatings and BPA producers and other stakeholders across Europe asking them about human and environmental exposures and the possibility of reducing these.
The agency asks respondents if they can reduce BPA concentrations and at what cost to performance levels. It also requests information on the development of BPA alternatives.
ECHA’s selection of the chemical for the Candidate List has not been unexpected. In early 2016, the European Commission classified BPA, first discovered in 1891, as a category 1b presumed human reproductive toxicant.
“That almost automatically categorized it as a SVHC,” said Robinson.
Once identified as being carcinogenic, coatings and BPA producers have to mention this danger in their safety data sheets (SDSs) with suggestions of ways of dealing with the risk.
BPA has been banned in baby bottles in the EU since 2011. Late last year the EU restricted the BPA content in thermal paper to 0.02 percent by weight.
The French government banned the manufacture and the use of BPA-based food contact materials five years ago. The French Constitutional Council, the country’s highest constitutional authority, intervened to allow production for the export of materials on the grounds that the restriction of trade was legally unjustified.
Last October the European Parliament voted in favor of a ban on the use of BPA in food contact materials. The parliament does not have powers to introduce legislation but it can exert influence in ways which can cause concern to industry.
Prohibiting the use of BPA could have a severe impact on coatings companies and their customers in the packaging sector because it could effectively stop all uses of the chemical.
“There is a danger that BPA being applied for other purposes could contaminate the machinery,” said Robinson.
The Commission is under pressure to take further regulatory steps on BPA because of the possibility that member states might follow the example of France by introducing their own measures.
But action through ECHA could take some time. Once BAuA presents a dossier to the RAC, probably late this year, it has 18 months to make a recommendation on which the Commission can take its time in making a final decision.
Meanwhile coatings producers will have to grapple with the uncertainties of not knowing what substances they can use in their formulations in future.