EC's Non-Automatic Ban Policy For CMRs In Cosmetics 'Plainly Illegal' – NGOs

According to the consumer umbrella organization BEUC, the European Commission changed its tune last year on whether carcinogenic, mutagenic or reprotoxic substances are automatically prohibited from use in cosmetics, taking a direction that compromises public safety and invites legal challenges. The EC maintains it has provided procedural and legal clarity while upholding the Cosmetics Regulation's general CMR ban.

An umbrella group of consumer advocacy organizations says the European Commission's updated regulatory approach to carcinogenic, mutagenic or reprotoxic (CMR) substances in cosmetic products is "plainly illegal" and could be a matter for the courts to resolve.

In a December letter to the EC's Working Group on Cosmetic Products, BEUC, aka the European Consumer Organization, lambasts what it sees as a change of direction at the Commission with regard to the controversial issue.

"Any implementing decision taken as a consequence of the Commission’s revised position on CMR substances [could] be challenged before the European Court of Justice under an action for annulment," according to BEUC, which comprises more than 40 national consumer advocacy groups from 31 European countries.

"In such an event, both legal certainty and the protection of consumer health would be endangered," BEUC adds.

Meanwhile, the EC maintains that measures it's taken over the past 16 months – including a draft omnibus act expected to be adopted later this year – are necessary to ensure legal certainty for industry and national authorities.

"There is no need for the Commission to amend the annexes of the Cosmetics Regulation for a ban to take effect," a system that "would change the default legal situation for CMR substances, delay implementation of bans and inevitably lower the level of consumer protection." – BEUC project officer

Central to the matter is the interface of the EU's classification, labeling and packaging regulation (No. 1272/2008) – designed to harmonize chemical hazard communication throughout the supply chain, including through the identification of CMR substances – and the Cosmetics Regulation (No. 1223/2009), which generally, but not always, prohibits use of CMR substances in cosmetic products. (Also see "EU Eyeing Carcinogen Tag For Titanium Dioxide Under CLP Reg; Why It Matters For Cosmetics" - HBW Insight, 28 Jul, 2017.)

Exceptions are made for CMR substances that meet specified criteria, including a decision from the EC's Scientific Committee on Consumer Safety that a given CMR ingredient can be used safely in cosmetic products under defined conditions.

The EC and BEUC are in agreement about the general ban. A Commission spokesperson confirmed as much in a Jan. 12 email to the Rose Sheet.

"In order to avoid any misunderstanding, it should be clarified that the Commission is convinced that 'CMR substances should be banned from use in cosmetic products in the EU to ensure consumer safety,' as laid down in Article 15 of the Cosmetics Regulation," the rep said, adding, "This question is undisputed."

The bone of contention, rather, is when and how substances flagged as CMR under the CLP regulation trigger the Cosmetics Regulation's ban. Similar "triggering" questions have arisen with respect to the Cosmetic Regulation's animal-testing ban and its interrelation with third-country requirements and other EU regulations such as REACH. (Also see "BASF Ingredient Case Begs For Verdict: Do REACH Animal Tests Violate Cosmetics Reg?" - HBW Insight, 13 Dec, 2017.)

The EC provided its perspective on the CMR issue during a September 2016 meeting of the Working Group on Cosmetic Products. Published minutes from the meeting include an annex outlining the EC's position.

In essence, the Commission asserts that substances classified as CMR under the CLP regulation cannot be considered automatically, instantly banned from use in cosmetics products. Rather, their prohibition in the cosmetics sector must be implemented by specific acts amending relevant annexes of the Cosmetics Regulation, which "are an integral part of the Regulation itself and legally binding," it notes.

The EC highlights language in the Cosmetics Regulation that it says supports this interpretation. For example, the regulation states, "To these ends" – ostensibly referring to the prohibition of Category-2 CMR substances (suspected based on limited evidence from animal studies and/or human evidence) – "the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny."

That procedure is the one used by the EC to subject proposed regulatory measures to committee review and consideration by the European Parliament and Council before they're adopted. The implication is that bans on CMR substances in cosmetics aren't official until they undergo this process.

Further, the Commission says, an "automatic ban" would be at odds with the treatment of CMR substances in other sectors, namely plant protection products and biocides.

BEUC, on the other hand, reads the Cosmetics Regulation as automatically banning use of CMR substances in personal-care products from the moment the classification is applied under the CLP reg.

"There is no need for the Commission to amend the annexes of the Cosmetics Regulation for a ban to take effect," asserted Pelle Moos, BEUC's project officer on chemicals and international trade agreements, in a Jan. 11 email.

The EC's contrary position "would change the default legal situation for CMR substances (allowed unless explicitly banned), delay implementation of bans and inevitably lower the level of consumer protection," he said.

BEUC argues that at minimum, ambiguity in the Cosmetics Regulation as to how CMR-classified substances should be managed necessitates "full democratic debate at [the] legislative level."

The organization urges the cosmetics working group to refrain from advancing the EC's proposed approach to CMR substances in cosmetics, which could create unacceptable health risks for consumers and exceed the Commission's authority, it suggests.

"The Commission seeks to codify its revised approach through implementing measures which de jure would go against the clear wording and meaning of the legislative act authorizing such measures in the first instance. That is plainly illegal. The revised approach transgresses the powers conferred on the Commission by the Legislator and thus lacks a legal basis – in short it is ultra vires," BEUC says.

National Authorities Amplify Calls For Automatic Ban

BEUC suggests that since December 2010, when Article 15 of the European Cosmetics Regulation went into effect, it has been widely accepted by legal experts and regulatory authorities that CMR substances are off-limits for use in the cosmetics industry the second their CMR status is applied under the CLP regulation.

Such practice is reflective of legislative intent, according to the NGO organization.

"When the European Parliament and Council enacted the Cosmetics Regulation in 2009, all parties including the European Commission understood that the ban on CMR substances should become automatic to ensure that a lack of full scientific certainty did not prevent or delay protective action. This common understanding thus reflects the precautionary underpinnings of the Cosmetics Regulation," BEUC asserts.

A number of national authorities, led by Denmark's Environmental Protection Agency, reportedly are aligned with BEUC in this view.

Going forward, the EC interprets the Cosmetics Regulation as requiring amendments to its ingredient annexes within 15 months of CMR application dates under the CLP instrument.

But varying approaches from one European member state to the next underscore the need for an EU-wide standard for implementing CMR substance bans, the EC says.

"Legal certainty can only be provided by inserting these substances in Annex II [banned substances] and removing them, where necessary, from Annexes III to VI of restricted or authorized substances for use in cosmetic products" under the Cosmetics Regulation, the Commission explained in materials provided to the working group, which includes representatives from both industry and the NGO community.

This is not the position that has been taken by the EC in previous communications, according to BEUC.

It appears that SCCS may have been operating in the past under a similar impression. In an April 2017 opinion on preservative polyaminopropyl biguanide, the committee noted that PHMB had been classified as a Category-2 CMR under the CLP regulation, a listing that applied starting Jan. 1, 2015.

"According to Art. 15 (1) of the Cosmetics Regulation, PHMB is considered prohibited as cosmetic ingredient from 1st January 2015," SCCS explained in background to the opinion, while noting the possibility for authorized use after the fact on the basis of a positive SCCS safety finding.

It's unclear whether the majority of member state authorities – and in turn manufacturers – were treating PHMB as prohibited in cosmetics at that time. Industry still had enough of a vested interest in PHMB to submit a new safety dossier to SCCS in May 2016 ahead of the committee's meeting, seeking a decision that would clear the ingredient's safe use at a lower maximum concentration level than previously sought.

Had industry already abandoned the preservative, reformulating away from its use to ensure compliance with an automatic ban, investment in updated safety data may not have been deemed worthwhile, notwithstanding the dire state of industry's preservative palette. (Also see "EC Trims Permitted Cosmetic Preservatives List, Warns About 'Stigmatizing' Safe Options" - HBW Insight, 24 Jul, 2017.)

SCCS ultimately determined the evidence compelling and issued a "safe for use" finding accordingly. (Also see "SCCS OKs Preservative PHMB At 0.1%, Leaving Room For EU Cosmetic Use" - HBW Insight, 20 Jan, 2017.)

Omnibus Act Adoption Expected By Fall 2018

The case of PHMB signals what could be at stake in the automatic ban debate. Generally, a system that requires amendments to the Cosmetics Regulation to prohibit CMR substances, rather than automatically banning them as soon as their CMR status is CLP-applied, gives industry substantially more time to secure a safe decision from the SCCS or meet other exemption terms before removing the ingredient from products.

Going forward, the EC interprets the Cosmetics Regulation as requiring amendments to its ingredient annexes within 15 months of CMR application dates under the CLP instrument.

The Commission also sees room in Cosmetics Regulation for granting transitional periods to facilitate manufacturer compliance, "provided the need for a transitional period and its length are duly justified," it says in its notes on the subject in the cosmetic working group's meeting minutes.

All would add up to the delays foreseen by BEUC, compared with the automatic ban model.

Adoption of an omnibus act, which was drafted last year in accordance with the EC's understanding of existing law regarding CMR substances in cosmetics, is expected by the second trimester of 2018, according to the Commission spokesperson.

BEUC remains hopeful that the proposed act will meet with resistance from EU lawmakers. "Both the European Parliament and Council can block the proposal and have in the past often done so where either institution considered that the Commission transgresses its legal powers, which in our view is also the case here," Moos said. (Also see "EU Endocrine Disruptor Regs In Limbo; Parliament Urges 'Suspected' Category" - HBW Insight, 16 Nov, 2017.)

"In the meantime," the BEUC officer continued, "Member States who disagree with the Commission’s position could of course also decide to enforce the automatic ban and force non-compliant products off the market."

He acknowledged that such a scenario would create "significant" legal uncertainty. "Ultimately, it may therefore fall to the Courts to settle this discussion," he concluded.