The European Commission’s public consultation on the EU Cosmetics Products Regulation to run until 21 June 2022.
The EU Cosmetics Products Regulation No. 1223/2009 (the EU Regulation) is the principal regulatory framework for ‘finished cosmetic products’ placed on the EU market, meaning the cosmetic product in its final formulation, as placed on the market and made available to the end user, or its prototype.
In March 2022, the European Commission (EC) opened a public consultation to consider how the EU Regulation could be improved in order to protect public health and the functioning of the internal market.
|This proposed targeted revision of the EU Regulation sits alongside the proposed revision of other key chemicals legislation, including the REACH Regulation No. 1907/2006 regarding the Registration, Evaluation, Authorisation and Restriction of Chemicals, and the CLP Regulation No. 272/2008 regarding the classification, labelling and packaging of substances and mixtures, forming part of the EC’s ambitious Chemical Strategy for Sustainability (the Strategy) – and the wider European Green Deal - which seeks to protect citizens and the environment against hazardous chemicals and encourage innovation to foster the development of safer and more sustainable alternatives.
The consultation welcomes information, views and experience from a variety of interested stakeholders including consumers and professional users of cosmetic products, manufacturers, importers, distributors, SMEs, civil society organisations and Member State authorities, including market surveillance authorities and customs authorities. The consultation remains open for feedback until 21 June 2022.
The EC’s proposals for the revision of the EU Regulation are expected to be published later this year and are likely to increase the regulatory risk and burden for companies selling cosmetic products on the EU market. Companies in the business of producing and selling cosmetic goods in the EU should be alive to these impending regulatory changes and if they have not done so already, take steps to check whether the chemical properties of their cosmetic products may, or may not, be compliant with the new regime.
The consultation is the second stage of the EC’s three-phased initiative to revise the EU Regulation and follows the publication of its Inception Impact Assessment which informed stakeholders of how the initiative aims to tackle the current deficiencies with the Regulation. Stakeholder responses to the Inception Impact Statement, including those from non-governmental organisations and businesses, have been published and are mostly supportive of the EU’s Strategy for the development of safer and greener chemicals.
The consultation questions are framed around a range of possible measures that are being considered by the EC to address the problems and risks arising from the Regulation in its current form. These measures include:
An automatic ban of the most harmful chemicals (the ’generic approach to risk management’), allowing their use only where it is proven to be essential for society.
Harmful chemicals, such as those with carcinogenic effects, are generally banned from use, although the use of other chemicals is currently only banned if the product is not “safe to human health when used under normal or reasonably foreseeable conditions of use”, as assessed on a case by case basis.
The EC is considering extending this ‘generic approach’ to ensure that cosmetics do not contain harmful chemicals that cause cancers, gene mutations, affect the reproductive or the endocrine system or are persistent and bioaccumulative, or contain chemicals affecting the immune, neurological or respiratory systems and chemicals toxic to a specific organ - save for in exceptional circumstances, e.g. if necessary for health, safety or critical for the functioning of society, and in the absence of alternative substances.
A new measure to take into account the combination effects from simultaneous or subsequent exposure to chemicals from different sources.
Over the years, reports have highlighted that certain chemicals may cause adverse effects to human health when used in combination with other chemicals, even if the individual substances are used with concentrations that are considered safe.
The Strategy states that in order to adequately address the effects of unintentional combined use, e.g. consumers using different soaps and detergents, there needs to be consistent legal requirements to take effective and systematic account of the risks from simultaneous exposure to multiple chemicals across chemicals-related policy areas.
A review of the definition of nanomaterial.
Nanomaterials are tiny particles measured in nanometres (i.e. one millionth of a millimetre), making them impossible to see with the naked eye.
The EU Regulation defines nanomaterials as ‘an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100nm’.
It also includes nanomaterial-specific provisions (including labelling) to ensure they are adequately assessed for safety if used as ingredients.
In 2011, the EC adopted a recommendation on the definition of nanomaterials which was tailored to facilitate consistent and efficient regulatory application. It is a horizontal definition and is therefore applied in several EU regulations including EU REACH, the Biocidal Product Regulation (BPR) and the Medical Devices Regulation. The EC is considering updating the definition provided for in the EU Regulation.
Improving labelling information on cosmetic products.
Whilst the EU Regulation lays down rules for information to be labelled on the packaging and/or contains of a cosmetic product, there are no rules governing digital labelling e.g. online labelling through the use of QR codes or via a website.
If essential product information, such as the product ingredients and warnings, is moved from a physical label affixed to packaging to a digital label, manufacturers will need to find a way to provide this information to consumers who do not have access to the internet.
This is part of a wider discussion by the EC as to the scope of digital labelling under the CLP Regulation. There is also, in tandem, an open consultation on the simplification and digitisation of labelling requirements of chemicals.
Streamlining scientific assessments of cosmetic products by reassigning the work of the Scientific Committee on Consumer Safety to the European Chemicals Agency (ECHA).
Different agencies and scientific committees provide scientific advice to the EC on chemicals, including cosmetics. This includes the work of the Scientific Committee on Consumer Safety of the EC (the SCCS) which performs scientific and technical work on cosmetics.
The EC is questioning the efficiency of having several committees on board to assess the same chemical. It is therefore seeking to improve the effectiveness, efficiency and coherence of safety assessments across EU legislation and to make best use of the expertise and resources in the EU agencies, in line with the ‘one substance, one assessment’ approach.
The Strategy therefore proposes reassigning the technical and scientific work on chemicals to EU agencies, including the work of the SCCS.
The UK’s cosmetics regulatory framework
Post Brexit, the production and distribution of cosmetics in Great Britain i.e. England, Scotland and Wales, is now governed by the UK Cosmetics Regulation (the UK Regulation), which is largely based on the provisions of the Regulation as retained EU law. Notably, the UK Regulation provides that for all cosmetic products sold to consumers in Great Britain after 31 December 2020, companies must appoint a ‘Responsible Person’, established in the UK, who is obliged to ensure that the cosmetics products that they make available are safe and legal obligations are met. For example, the Responsible Person should:
- Know which ingredients are used in their cosmetic products, including those which are harmful or nanomaterials.
- Be aware of restrictions on what can be put in cosmetic products.
- Keep an up to date document with information on cosmetic products.
- Ensure all information on packaging, labelling and instructions is clearly visible.
- Notify the UK product safety regulator, the Office for Product Safety and Standards (OPSS) about the cosmetic product before it is made available to consumers.
- Inform the OPSS of any serious harmful effects which are reported.
- Be able to prove that any claims made when marketing the product are correct.
Cosmetic products sold in Northern Ireland (NI) remain governed by the EU Regulation in accordance with the NI Protocol. For cosmetic products sold to consumers in NI, the Responsible Person must be established in NI or the EU.
Following in the footsteps of the EC, the UK government is taking steps to update the UK Regulation to provide for safer and more sustainable chemicals. Changes include the prohibition of the following chemicals used in toy and cosmetic products:
Non-compliant products cannot be placed on the market after
Fragrance allergens Atranol, Chloroatranol and Methyl heptine carbonate.
15 October 2022
Chemicals assessed by SAG-CS- Aluminium, Formaldehyde, and aniline.
15 December 2022
|Non-compliant products cannot be placed on the market after
|Products already placed on the market can be made available until
|15 October 2022
|15 December 2022
|Chemicals assessed by SAG-CS – Salicylic Acid and deoxyarbutin
|15 December 2022
|15 March 2023