EU Chemicals Strategy Stands To Transform Cosmetics Regulation
Cosmetics Europe Director-General John Chave says whichever way the European Commission proceeds under its recently released sustainable chemicals strategy, there almost certainly will need to be changes to the Cosmetic Products Regulation. Chave counts the strategy among “the biggest legislative policy proposals affecting our sector probably ever.”
The European Commission’s vision for a sustainable chemicals future stands to alter the bloc’s regulatory and institutional landscape, with significant implications for the cosmetics industry.
The prospect of automatic, hazard-based bans or restrictions on use of endocrine disruptors or other chemicals of concern across industry sectors would contrast sharply with the more methodical, risk-based system currently in place for cosmetic products in the European Union.
But that is precisely where the EU may be headed under the European Commission’s recently released Chemicals Strategy for Sustainability, part of its Green Deal set forth in December 2019.
According to the strategy communication, “a ‘generic approach to risk management’ is an automatic trigger of predetermined risk management measures (e.g. packaging requirements, restrictions, bans, etc.) based on the hazardous properties of the chemical and generic considerations of their exposure.”
The Commission aims to extend the generic approach to ensure that consumer products are free of chemicals that cause cancers or gene mutations, affect the reproductive or the endocrine system, or are persistent and bioaccumulative, while exploring its further application to chemicals that pose other health concerns, according to the Chemicals Strategy.
“I think it’s fair to say that apart from the actual changes to the Cosmetics Products Regulation, this is the biggest sort of legislative policy proposal affecting our sector coming out of the European Union probably ever,” said Cosmetics Europe director-general John Chave in a 28 October interview.
“The challenge for the industry is to make sure that of course we defend our interests, but also that we find a way to contribute constructively to the debate and what is coming,” Chave said.
Currently, the European Cosmetic Products Regulation (CPR) represents a largely risk-based framework for assessing the safety of cosmetic products and ingredients, entailing specific use and exposure considerations, not merely reliance on hazard identification.
Rules of procedure for the Scientific Committee on Consumer Safety (SCCS), which regularly advises the Commission on cosmetic safety matters, dictate that the committee’s recommendations must be supported by science-based risk assessments. Hazard is mentioned just once in the rules document.
To an extent, the CPR cordons off cosmetics from the effects of the EU’s Registration, Evaluation, Authorization and Restriction of Chemicals and other chemicals regulations. Certain cosmetic uses of REACH-designated substances of very high concern are exempt from the program’s authorization requirements, for example. Instead, they are dealt with through the CPR. (Also see "EU’s Addition Of Butylparaben To SVHC List Won’t Impact Cosmetics Use … Or Will It?" - HBW Insight, 6 Aug, 2020.)
Similarly, substances categorized as suspected carcinogens based on limited evidence under the EU’s hazard-focused Classification, Labeling and Packaging regulation can be used in cosmetic products if the SCCS determines them safe. (Also see "EU Eyeing Carcinogen Tag For Titanium Dioxide Under CLP Reg; Why It Matters For Cosmetics" - HBW Insight, 28 Jul, 2017.)
However, the EU Chemicals Strategy’s discussion of the generic approach to risk assessment signals that changes almost certainly will be needed to the Cosmetic Products Regulation as Europe moves in a more precautionary, hazard-averse direction.
“In the Cosmetics Regulation we have a very sector-specific risk-management process, which we think has worked really very well. It’s pretty much the gold standard for the world. But it’s unlikely that they could adopt a generic approach without changing some of this sector-specific regulation,” Chave said.
The Commission’s stated intention to ban use of endocrine disruptors in consumer products “as soon as they are identified, allowing their use only where it is proven to be essential for society,” is another major cue, according to Chave.
He noted that debate continues to swirl around definition and identification of endocrine disruptors. Meanwhile, the SCCS has opined that endocrine disruptors in cosmetics can be, and are, adequately addressed through CPR controls. (Also see "EC Releases Endocrine-Disruptor Criteria, Drawing Heavily On WHO Definitions" - HBW Insight, 24 Jun, 2016.)
“If they [the Commission] go along in the way that they intend, and you realize this is just the first position in what might be a long, drawn-out process, then it will change the way that cosmetics are regulated in the EU in potentially quite fundamental ways,” Chave said.
He added, “Obviously this is something that we need to engage on as an industry in Europe.”
SCCS’ Future In Question
Other aspects of the Commission’s Chemicals Strategy, including its goal of protecting people and the environment from the combination effects of chemicals and its proposed “one substance, one assessment” model for centralizing chemical reviews and promoting risk-management uniformity across sectors, make Cosmetics Europe believe cosmetics regulatory changes lie ahead. (Also see "Endocrine Disruptors, The European Green Deal And The Politicization Of EU Chemical Programs" - HBW Insight, 24 Jan, 2020.)
“Whichever way you look at it, it’s difficult to avoid the conclusion that we will be involved in a discussion with the Commission and other stakeholders about the Cosmetic Products Regulation,” Chave said.
Whether and how the Commission moves to streamline chemicals decision-making through structural changes or consolidations – such as the merging of agencies – are matters of conjecture. “What is less speculative is that they want to do something with the SCCS,” Chave said.
He noted, “The big question for us is, where would [the strategy] leave the SCCS? Are its ways of working, the notes of guidance for example, going to be changed? Is the composition going to be changed? Is the basis on which it makes its opinions, from a regulatory perspective, going to be changed? These are all huge questions for the industry that we don’t yet have clear answers on.”
If It Ain’t Broke…
Chave acknowledged that the CPR does not address environmental concerns. The European cosmetics industry is ready to discuss those, he said, but it would ask for the same scientific, risk-based principles to govern environmental considerations that currently apply to human health assessments.
Cosmetics Europe has serious concerns about the Chemicals Strategy’s potential impact on innovation, as does the European Chemical Industry Council (Cefic). (Also see "EU’s Sustainable Chemicals Strategy Lacks Industry ‘Game Plan’ To Support Innovation, Competitiveness" - HBW Insight, 15 Oct, 2020.)
“The Commission says in the paper that it believes this is an economically positive proposal because Europe will become the world leader in sustainable chemistry. What I think we will be asking the Commission is, ‘OK, you’ve got a lot of proposals in this document, and we share the concern about addressing sustainability, of course we want to play our role in that. But what is your broader vision for our industry?’”
Chave continued, “Because what we hear mostly is more and more regulation, more and more clamping down on ingredients which we use to innovate, which we regard, and the SCCS regards, as safe. A little more concentrated thinking on those aspects I think would reassure many in our industry who just see this as a move away from risk towards hazard approaches, imposing further restrictions and constrains on innovation in a context where the European Cosmetics Products Regulation has worked really perfectly well. We don’t think the case has been made clearly that this system is broken.”
In any event, Chave emphasized the importance of industry engagement on the issue.
“The way that the debate is going in Europe at the current time, which is slightly indicated by the boldness of the proposal, is that industries that seek to avoid making a positive contribution to sustainability goals are not going to be well respected by other European Union stakeholders. So the challenge for the industry is to make sure that of course we defend our interests, but also that we find a way to contribute constructively to the debate and what is coming,” he said.