REGULATORY CSS
including those contained in products that in themselves are not known to present any direct risk. It eschews the current regime’s preference for case-by- case risk assessments, which may find that certain uses of an ostensibly hazardous chemical are not harmful in small enough quantities.
This contrasts with the current EU Cosmetics Regulation, whose case-by-case risk assessments consider how chemicals are used and in what quantities. That means ingredients with hazardous properties are allowed if used in ways and quantities that pose a significantly reduced risk. The regulation even states that “a hazardous property of a substance does not necessarily always entail a risk”, because the level of risk partly depends on how a substance is used.
That said, carcinogenic, mutagenic and reprotoxic (CMR) substances are to some extent already covered by a hazard-based approach, although the CSS could lead to tighter rules.
For example, the Cosmetics Regulation already bans the highest-category CMR hazards. That means substances known to be carcinogenic, mutagenic or reprotoxic are banned from all cosmetics, regardless of the product or the concentration.
Those suspected of being so are also generally prohibited, unless a risk assessment determines they can be added to an exclusive list of chemicals that can only be used in the approved ways. “Up to now, when a CMR substance has been identified, the regulation has allowed industry the possibility to defend the use of a CMR on the basis of exposure,” Chave says.
Watson argues a hazard-based approach is justified because “we’re exposed to a whole mix of chemicals throughout our day, throughout our lives”, making case-by- case risk assessments inadequate. “General risk assessment is more protective than specific risk assessment,” she notes. Chave, however, contends that the hazard-based rationale leads to absurd conclusions. For example, coffee – though not known to be harmful in itself – contains acrylamide, which the International Agency for Research on Cancer (IARC) classifies as a “probable human carcinogen”. “If you look at merely the inherent qualities or features of a substance, not only will you be banning coffee and lots of other things, you will also drastically reduce the amount of ingredients available to consumers – without any gain to consumer safety, because what matters is exposure,” says Chave.
But Élise Vitali, Policy Officer on Chemicals at the European Environment Bureau, a Brussels-based NGO, argues the difference between coffee and cosmetics boils down to informed consent.
“There will be fewer ingredients to use and to provide innovative products
“What appears to be the case with the new proposals is there will be automatic bans without possibility of examining the exposure.”
The CSS says the Commission intends to extend this approach to endocrine disruptors, as well as persistent and biocumulative substances, such as per- and polyfluoroalkyl substances (PFAS).
“Ample evidence and citizens’ worries justify that for the most harmful chemicals the generic approach to risk management becomes the default option, in particular as regards their use in consumer products,” it says. It also proposes an “impact assessment” to decide how and when to extend the framework even further, to chemicals affecting the “immune, neurological or respiratory systems and chemicals toxic to a specific organ”.
Campaigners for a hazard-based approach say individual risk assessments ignore cumulative health or environmental hazards caused by consumption and production more broadly.
“When the industry says we need to do a risk-based approach – which is one chemical at one time on one end point – that doesn’t actually reflect the reality of our world,” says Anna Watson, Head of Advocacy at CHEM Trust, a campaign group based in the UK and Germany.
50 January 2021
“I like coffee, I know about the carcinogenic substances in it,” she says, but consumers “don’t know that there are substances that bioaccumulate in the environment in our cosmetics”. Vitali adds that, unlike coffee, a cosmetics product may contain dozens of different man-made chemicals.
The measures outlined in the CSS would require changes to various EU regulations, including the 2009 Cosmetics Regulation and general chemical control system REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), which was adopted at the end of 2006. The existing Cosmetics Regulation individually names and regulates thousands of ingredients. It prohibits more than 1,300. For the rest, it imposes concentration limits and other restrictions. For example, some chemicals are only cleared for certain products, such as hair dye. Others are only for professional use or cannot be given to small children. Some chemicals cannot be mixed and products containing them must be stored in the right containers, often with labels carrying information or warnings.
When new concerns arise about a cosmetic ingredient, they are investigated by the EU Scientific Committee on Consumer Safety (SCCS), an independent body managed by the Commission.
The SCCS also re-evaluates ingredients covered by the Cosmetics Regulation every five years. The committee can then issue new guidelines on whether the ingredient can be used safely, and if so, in what way and at what level of exposure.
The Cosmetics Regulation has been amended dozens of times since 2009, most recently in November 2019.
THE ENDOCRINE DISRUPTORS ISSUE One key issue is that the Chemicals Strategy for Sustainability (CSS) proposes to tighten restrictions on endocrine disruptors, which interfere with hormone systems and can harm unborn children.
“Endocrine disruptors have been possibly the most controversial ingredient group area of recent times,” notes Chave, “and there have been some NGOs and consumer associations advocating for a complete ban of endocrine disruptors in cosmetics.”
cosmeticsbusiness.com
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