European Commission unveils proposed ban on bisphenol A in food packaging

Bisphenol A (CAS No. 80-05-7): Identity and uses

• The substance 4,4′-isopropylidenediphenol, also known as bisphenol A (BPA), is a member of the large bisphenols family of substances that share similar chemical structures and applications. Used in the manufacture of polymers and resins, BPA is commonly employed in certain plastics and epoxy resin.
• Products containing BPA encompass a wide range of applications. They vary from articles like reusable bottles and tableware, to waterpipes, sports equipment, flexible glass applications, CDs and DVDs, and many more.
• BPA has a long history of use in food contact materials. It is commonly used to produce epoxy resins that serve as the basis of coatings and varnishes for internal and external surfaces of metal food contact applications, like food and beverage cans and lids. Additionally, it is a common constituent in certain plastics including polycarbonate and polysulfone plastics with applications in food storage, and food processing and production equipment, among others.
• Other common food contact products where BPA is present are printing inks, adhesives, ion-exchange resins, and rubbers.

The regulation of BPA in the EU today

• BPA has been jointly registered (as a full registration) under REACH with over 60 registrants manufacturing or importing the substance in the tonnage band at or above 1,000,000 metric tons per year. Registration at this high level indicates that the substance has a significant presence on the EU market and, given the wide variety of its applications, has a relatively high likelihood of coming into contact with diverse populations, including consumers, and professional and industry workers.
• BPA has been identified as a substance of very high concern (SVHC) under REACH, satisfying the Article 57 criteria for reproductive toxicity (Art. 57c), and endocrine disrupting properties for human health and the environment (Art. 57f). As such, it has been added to the EU’s Candidate List, which is the first step in the process to phasing out substances under REACH’s authorization scheme.
• BPA has also been restricted under REACH’s Annex XVII. Entry no. 66 bans the placing of BPA on the market in thermal paper in concentrations equal to or greater than 0.02% by weight.
• The substance has a harmonized classification entry (i.e., eye damage, cat. 1; skin sensitization, cat. 1; specific target organ toxicity – single exposure (STOT-SE), cat. 3; and reproductive toxicity, cat. 1B) in the harmonized list – table 3 of part 3 in Annex VI – of the Classification, Labeling and Packaging Regulation (EC) 1272/2008 (CLP Regulation). In addition to hazard communication obligations, harmonized classification under CLP has knock-on effects triggering risk management measures like restriction and the setting of limit values under certain sectoral laws, such as the Cosmetics Regulation and occupational exposure rules.
• EU sectoral legislation restricts or bans the use of BPA. It does this either through an explicit listing on an annex of restricted or banned substances or by way of a “generic restriction,” for example, by reference in a legal act’s provisions to meeting the criteria for hazard classification under the CLP Regulation. Below is a non-exhaustive list of such legislation that restricts BPA, along with the type of restriction:

• BPA’s regulation across so many sectors affecting different parts of the supply chain (i.e., industry, professional, consumer) indicates that the substance is used widely throughout the EU market. Again, the high volumes and widespread use in the EU has led to the EU authorities implement these risk management measures to ensure its safe use.
• Other ongoing regulatory activities concerning BPA: Germany is currently preparing a proposal for a group restriction on bisphenols, including BPA, under REACH. The German competent authority was originally expected to submit the proposed restriction in fall 2022. Its purpose is to ban bisphenols with endocrine disrupting properties for the environment. However, after considerable delay it was withdrawn in August 2023, with the explanation that further work on the proposal was necessary given the complexity of restricting an entire group of chemicals. The undertaking is part of the EU’s substance grouping initiative, under the Chemicals Strategy for Sustainability (CSS), that aims to speed up regulatory action, avoid regrettable substitution, and save time and resources.

EU food contact materials (FCM) legislation regulating BPA

• Until now, BPA has been allowed for use under strict conditions pursuant to Regulation (EU) 10/2011 on food contact plastic materials and articles (Plastics FCM Regulation). These conditions encompass bans on use in polycarbonate infant feeding bottles and spill proof drinking cups or bottles for infants and young children, which were introduced in 2011 and 2018, respectively.
• Likewise, a specific migration limit (SML) of 0.05 mg/kg was set in 2018 for BPA for food contact varnishes and coatings and other plastic articles and materials. It was derived from the temporary tolerable daily intake (t-TDI) of 4 mcg/kg body weight per day established the European Food Safety Authority (EFSA) in a 2015 report.

Now, the Commission has moved to ban bisphenol A and related substances altogether from food contact materials

• The Commission on February 9 published a proposal on its “Have your say” portal, introducing a complete ban on BPA, with few exceptions, for use in FCMs, including in food packaging, its constituents, and repeat-use food contact applications like food production equipment used in the food manufacturing industry.
• The proposed regulation, for which the Commission has now launched a four-week consultation to elicit feedback from stakeholders and other interested parties, also bans bisphenol A-related substances to prevent so-called regrettable substitution.

Details of the proposal

• The following is an article-by-article analysis of the proposed legislation.
• Article 3 bans the use of BPA “at any manufacturing stage.” Specifically, this provision targets food contact varnishes and coatings, printing inks, adhesives, ion-exchange resins, and rubbers, as well as placing on the market finished food contact products comprised partly or wholly of these materials manufactured using BPA.
• Article 4 prohibits the use of bisphenols and bisphenol derivatives listed in Annex VI of part 3 of the CLP due to their harmonized classifications as category 1A or 1B mutagens, carcinogens, and reproductive toxicants, or category 1 endocrine disruptors for human health. These substances are, again, expressly forbidden in the production of food contact varnishes and coatings, printing inks, adhesives, ion-exchange resins, and rubbers.
• Article 3(2) exempts the use of BPA as a precursor to synthesize bisphenol-A diglycidyl ether (BADGE) (CAS RN 1675-54-3) that is further used as monomers in the manufacture and placement on the market of “BADGE-based heavy-duty varnishes and coatings.” Article 2(d) defines these as “non-self-supporting polymeric varnishes and coatings synthesised directly only from BADGE and its derivatives as monomers, to be applied on self-supporting materials or articles with a capacity greater than 250 litres, as well as pipelines belonging to or connected with them.” In other words, the exemption only applies to those materials and articles whose capacity exceeds 250 liters. Likewise, the exemption applies to derivatives of BADGE.
• The exemption is subject to several restrictions listed at Article 3(2) (a), (b), and (c), including a limit of detection (LOD) of 0.01 mg/kg set for migration of BPA from materials and articles that BADGE-based heavy-duty varnishes and coatings are applied on.
• Article 4(2) exempts bisphenols and bisphenol derivatives from the ban that meet the conditions laid out in subpoints (a) through (d). Specifically, these provisions concern obtaining authorization for such chemicals as new substances under Article 9 of the framework Regulation (EC) 1935/2004 on FCMs (FCM Framework Regulation). Authorization depends on applications being submitted within nine months of this regulation entering into force, or if a relevant bisphenol or bisphenol derivative is newly added to the CLP’s Annex VI, within nine months of its date of application in the harmonized list.
• Annex III of the proposed regulation amends the Annex I list of authorized substances of the Plastics FCM Regulation, providing a use exception for disodium salt of BPA (disodium 4,4′-isopropylidenediphenolate) on condition that it is only used for manufacture of polysulfone resins that are employed in filtration membranes. Annex III also eliminates the existing entry for bisphenol A in Annex I of the Plastics FCM Regulation, removing the substance’s prior authorization for use in the EU.
• Article 5 stipulates that continuous monitoring must be conducted for the presence or migration of BPA from (1) food contact BADGE-based heavy-duty varnishes and coatings, (2) polysulfone resins for use in filtration membranes, and (3) paper and board containing recycled material.
• Article 5, (2) through (6) specify the related requirements, including methods of analysis, sampling quantities and frequencies, and preventative measures to take if BPA is discovered in food contact materials. Economic operators are required to submit a monitoring report to the competent authority of the Member State where the food contact material or article was tested every 12 months after this regulation enters into force. The report must include the batch or period of sampling, method of analysis used and the monitoring results. If the presence of BPA is confirmed, “its level shall be reported without delay” to the competent authority and, “within 20 working days from the date when a result [was] generated,” planned remedial actions must be provided. Operators are also required to report the results of the remedial actions once they have been implemented.
• Article 6 lays down the method for verifying that BADGE-based heavy-duty varnishes and coatings applied to materials and articles meet the rules on migration. The provision references the relevant sections of the Plastics FCM Regulation. Under this provision, economic operators are also required “to ensure that competent authorities can take samples of intermediate preparations of BADGE-based heavy-duty varnishes and coatings before they are applied to other materials to verify their degree of purity and composition.”
• Article 7 requires businesses to ensure a written declaration accompanies the relevant materials and articles, pursuant to the FCM Framework Regulation. The declaration must state that the goods in question are in compliance with the rules applicable to them.
• Article 8 updates the Regulation (EC) 1895/2005 on the restriction of use of certain epoxy derivatives in FCMs, banning the use of BADGE in materials and articles with a capacity of less than 250 liters. Likewise, it stipulates that such materials and articles with a capacity between 250 liters and 10,000 liters are restricted from releasing the Annex I-listed substances exceeding the quantities laid out here.
• Article 9 amends Annex I of the Plastics FCM Regulation, referring to the proposed regulation’s Annex III. As explained above, Annex III concerns the introduction of the exception for bisphenol A disodium and the complete removal of entry 151 for BPA from the Annex I authorized list.
• An 18-month transition period is established for economic operators to prepare for compliance with the changes introduced by this proposed regulation. Specifically, final food contact articles, or products, placed on the market composed of plastics, varnishes and coatings, printing inks, adhesives, ion-exchange resins, and rubbers don’t have to comply with the proposed changes until 1.5 years after their entry into force.
• For three types of finished products singled out in this provision (Article 9), a three-year transition period applies, instead of the usual 1.5 years. This extended transition concerns single-use final food contact products (1) intended to be filled with processed fruits, vegetables, and fish products, (2) on which a varnish or coating has been applied specifically to the exterior metal surface, and (3) repeat-use final food contact products used as components in professional food production equipment.
• Nine months before the transition ends, suppliers of intermediate food contact materials and articles that are not in compliance with these new rules must indicate this fact in the accompanying declarations of compliance. Likewise, indication in the declaration must be conveyed that the intermediate products in question can only be employed for manufacturing final articles intended for placing on the market before the transitional period applicable to those final articles ends.
• Almost the same provision applies for repeat-use final food contact articles to be used in professional food production equipment. The only difference is that suppliers of these products are required to provide the relevant information in the declarations of compliance after entry into force of the new rules until the three-year transition period ends.
• Article 10 also concerns how long products placed on the market before the end of the applicable transition but not yet in compliance with the new rules are allowed to remain in circulation. Final food contact articles, with two exceptions, are allowed to remain until the exhaustion of their stocks. Single-use final food contact articles for packaging food and not yet filled with food must be used at the latest 12 months after the applicable transition period ends. Similarly, economic operators are required to remove repeat-use final food contact articles used in food production equipment that’s not in compliance with the proposed rules at the latest 10 years after expiration of the applicable transition period.
• Finally, Article 11 repeals Regulation (EU) 2018/213 on the use of bisphenol A in FCM varnishes and coatings, since the proposed rules supersede the provisions in this 2018 regulation.

Analysis

• The Commission based its decision to ban BPA on EFSA’s April 2023 opinion, which established a new tolerable daily intake (TDI) of 0.2 ng/kg of body weight for the substance, or roughly 20,000 times lower than the 2015 provisional TDI of 4 mcg/kg (or 4 000 ng/kg) of body weight. Given such a low TDI, the EU executive concluded that even miniscule amounts of BPA could migrate from FCMs, exposing people to unacceptable levels of the substance.
• The Commission also justified banning BPA outright citing the absence of validated analytical methods to quantify the migration of BPA reliably and consistently at such low levels.
• These proposed changes will have significant implications for the global plastic FCM industry, considering the high import and manufacture levels of BPA in the EU, as REACH registrations confirm. While some monitoring and reporting requirements will be limited to a few applications – the BADGE-based heavy-duty varnishes and coatings, polysulfone resins for filtration membranes, and paper and board containing recycled material – all BPA suppliers will be required to meet the declaration of compliance obligations, including Articles 3, 15, and 17 of the FCM Framework Regulation concerning general provisions for food contact, labeling, and traceability requirements.
• Industry will need to look toward new alternatives to substitute bisphenol A, given the proposal’s wider ban on other bisphenols and bisphenol derivatives. Except for the few exemptions and exception in the short- to mid-term, the EU will have eliminated the substance in FCMs in the next three years. More generally, other ongoing developments in the EU, like Germany’s work on a group restriction on bisphenols, flags these substances as being on the way out.

Next steps

• The Commission’s draft regulation is now open for a four-week public commenting period until March 8.
• The “Have your say initiative” page states that the Commission is expected to adopt the proposal in the first quarter of 2024.

To contact the author of this piece, please email Scott Stephens ( [email protected])
To contact the editor of this piece, please email Alexander Gaffney ( [email protected])

Key Documents and Dates

• • Food safety – restrictions on bisphenol A (BPA) and other bisphenols in food contact materials, “Have your say” initiative (February 9, 2024)