GTF MCAMPS BLOG

Environmental safety: a new aspect of cosmetics regulation

30 June 2023 | Cosmetics, Legislation, News

Seguridad medioambiental y cosmética

The Cosmetics Regulation (EU) No 1223/2009 has, in the more than 10 years since it came into force, succeeded in creating a common regulatory framework in the field of cosmetics for all EU member states. At present, a cosmetic product that is legal in Spain or Italy will also be legal – once its labelling has been adapted – in France and Germany. And this has helped to open the doors of the ‘eurozone’ to all companies in the sector.

In short, an open market – the EU Member States – has been created in which all cosmetic products are subject to strict requirements to ensure consumer safety. For its part, the European Commission has established mechanisms for monitoring and assessing the risks posed by cosmetic ingredients to human health. This task has been faithfully carried out by a committee of experts: the Scientific Committee on Consumer Safety (SCCS)

However, the wording of the Regulation (EU) No 1223/2009 on Cosmetic Products It is currently undergoing a further update, as the European Commission wishes to add a new security provision to this legal text: the environmental safety. The fact is that, whilst consumers have always demanded cosmetic products that are safe for human health, they now also want the ingredients used in their manufacture not to pose a risk to the environment. Furthermore, they want these products to be sustainable, to generate as little plastic waste as possible and to minimise their environmental footprint as much as possible.

Do you know how environmental safety is affecting – and will affect – the regulation of the cosmetics sector and its ingredients? Read on!

 

Seguridad medioambiental y cosmética

Ensuring environmental safety will mark a new development in the safety assessment of cosmetic products and ingredients

One of the most significant challenges facing the European cosmetics industry is to keep abreast of the constantly changing regulations on ingredients, labelling, packaging, … and to apply it well in advance to avoid incurring additional costs (destruction of stock or withdrawal from the market). Most regulations and new restrictions on cosmetic ingredients, so far, have been aimed at to protect consumers’ health.

The expert group known as SCCS: Scientific Committee on Consumer Safety The European Commission is responsible for assessing the available toxicological data on the ingredient, issuing an opinion on human safety which is ultimately regulated and published by the European authorities, with specified dates for entry into force. In this regard, it is crucial for the cosmetics industry to anticipate the dates of the new regulations as early as possible, in order to plan and prioritise the best business strategy.

Furthermore, there is currently another extremely important aspect to consider regarding the regulations and restrictions on the products we consume. This is the environmental impact they have. Indeed, new restrictions and regulations are now being introduced that apply to cosmetics, and which are aimed at protect the environment. At this level, the European Chemicals Agency (ECHA), which assesses substances from the perspective of both human and environmental safety, is issuing regulations – in parallel with the SCCS– which also apply to cosmetic products. 

A paradigm shift in the regulation of cosmetic products: from human safety to environmental safety 

The appearance of the environmental safety of cosmetic products, which for years has been a secondary issue, has now come to be taken seriously at the highest level, particularly following the publication of the new European legislation on plastic waste. And everything suggests that, from now on, Cosmetic products and ingredients must not only be safe for human health; they must also be environmentally friendly.

And this new paradigm presents a challenge for manufacturers: with all these changes and overlaps, it has clearly become more difficult for the industry to keep track of the ingredients or substances that may be affected by future environmental regulations.

The framework document governing cosmetics in Europe, the European Cosmetics Regulation 1223/2009, is currently under review with a view to producing a new, updated legal text, in which For the first time, environmental considerations will be taken into account when assessing cosmetic ingredients. To improve the effectiveness, efficiency and consistency of ingredient assessments, the assessments will be reorganised so that, for each substance, a one-off assessment, grouping the risks to human health and environmental risks. For this reason, the group of SCCS will be transferred to the responsibility of ECHA.

The European body ECHA It is assessing chemicals solely on the basis of their intrinsic hazard properties rather than on a risk assessment, so it will be extremely important to monitor the situation to ascertain the impact this will have in the future. Until this harmonisation of ‘’a single assessment per substance’, the cosmetics industry must remain alert to any changes that may affect individual ingredients as a result of various types of assessments, so that it can implement them before the deadlines set.

Seguridad medioambiental: el futuro de la regulación de cosméticos

Latest developments in cosmetics regulation

GTF M. Camps facilitates and advises on the regulatory monitoring of its clients with the aim of anticipating and identifying potential risks, so as to plan appropriate strategies for each company and avoid additional costs. To this end, our technicians keep up to date with the notices regularly published by both the committee SCCS as ECHA.

And in fact, in recent months there have been several publications that directly affect a number of cosmetic ingredients. Over the coming years, new restrictions will be introduced on:

    • Formaldehyde-releasing preservatives
    • Fragrance and Homosalate sunscreen

Furthermore, in a few days’ time (July 2023), they will no longer be permitted to be placed on the European market or marketed as an ingredient various cosmetic products affected by previous notices issued by these bodies and which do not comply with certain new dosage restrictions depending on the type of cosmetic. These include four sunscreens, a hair dye and an antioxidant:

    • Butylated hydroxytoluene (BHT) (antioxidant)
    • Acid Yellow 3 (hair dye)
    • bis(diethylamino-hydroxybenzoylbenoyl)piperazine (sunscreen)
    • bis(diethylaminohydroxybenzoylbenzoyl)piperazine (nano) (sunscreen)
    • Benzophenone-3 (sunscreen)
    • Octocrylene (sunscreen)

Finally, there is a list of ingredients that will be banned in cosmetics, with no transition periods, towards the end of 2023:

    • Ammonium bromide
    • Dibutyltin bis(2-ethylhexanoate)
    • Dibutyltin di(acetate)
    • Tellurium dioxide
    • Barium diboron tetraoxide
    • 2,2-dimethylpropan-1-ol, tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol
    • 2,4,6-tri-tert-butylphenol
    • 4,4’-sulphonyldiphenol; bisphenol S
    • Benzophenone
    • Quinoclamine (ISO); 2-amino-3-chloro-1,4-naphthoquinone
    • Perfluoroheptanoic acid; tridecafluoroheptanoic acid
    • methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate
    • valifenalate
    •  6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts
    • 6-[(C10–C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid

    • 6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid
    • Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione
    • 1,3,5-triazine-2,4,6-triamine
    • melamine
    • Fluopicolide (ISO); 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide
    • N-(2-nitrophenyl)phosphoric triamide
    • N-(5-chloro-2-isopropylbenzyl)-N-cyclopropyl-3-(difluoromethyl)-5-fluoro-1-methyl-1H-
      pyrazole-4-carboxamide; isoflucypram
    • Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-
      isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and 3-(difluoromethyl)-1-
      methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-
      [yl]pyrazole-4-carboxamide [relative content: >78% syn isomers, <15% anti isomers];
      isopyrazam;
    • Neem, extracted from the kernels of Azadirachta indica using water and further
      processed using organic solvents;
    • Cumene

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