The principal framework regulating cosmetics in the European Union (EU) is Regulation (EC) N° 1223/2009, which replaced Directive 76/768/EC. The new legislation had the twin objectives of strengthening cosmetic product safety and streamlining the framework for stakeholders.
In theory, the 2009 legislation opened the way for risk-based exemptions for any form of carcinogen, mutagen or reprotoxic (CMR) substance, banned under the Cosmetics Directive of 2003. In reality, the law was interpreted as meaning listed substances were automatically banned, removing the need for a banned list of substances in Annex II. Exempted substances were still listed in Annexes III and IV, but there was no definitive list of banned substances within the Cosmetics Directive. This created an unclear legal situation when a substance on the positive list became listed as a CMR.
This lack of clarity led to the European Commission’s legal department recommending a return to the original interpretation, with a requirement for both banned and exempted lists (Annex II-IV) to be kept. This generated a problem because, between 2010 and 2016, around 200 substances had been banned and a few had been exempted. These substances now needed to be codified within the relevant Annexes. In addition, not all Member States agreed on the interpretation of the law, meaning there is now a risk of the EU not having harmonized enforcement.
For stakeholders, this lack of clarity can make it difficult to successfully bring finished cosmetic products onto the European market. The following are some of the debates that are ongoing and may affect future policies relating to cosmetic product regulations in the EU.
Most of the debate surrounding the identification of substances that exhibit endocrine-disrupting properties is taking place in the biocide and pesticide industries, but stakeholders should be aware that, when criteria have been agreed, they will probably effect change in cosmetic legislation. While there is no obligation on the part of regulators to revise regulations, and experts on the Scientific Committee on Consumer Safety (SCCS) have stated that the normal risk-assessment process is adequate for endocrine disruptors, there is a belief that emotional and political debate may mean a CMR-like approach is adopted.
The discussion on nanomaterials and how to regulate them, is currently being spearheaded in the cosmetics sector. Concerns over nanomaterials arrived at a time of questions rather than answers about these substances and this created ill-defined regulations. Many stakeholders will have first-hand experiences of the difficulties that resulted.
Uncertainty meant the EU’s nanocatalog contained several errors, including wrongly notified materials. By working with the appropriate authorities and industry associations, the catalog has been significantly improved, but at a cost of almost two year’s delay.
This lack of clarity will cause problems when, in 2018, stakeholders face strict enforcement against non-compliant products. This is especially true of products notified on the Cosmetic Products Notification Portal (CPNP) as containing non-preservatives, UV filters or colorants but which are not listed in the respective positive list, and products notified in the CPNP as containing other nano-provisions but not listed in Annex III or notified under Article 16. Stakeholders should also expect the Commission to review nano-provisions in the Cosmetic Regulation in 2018 and add a harmonized definition of nanomaterial to the Cosmetics Regulation.
In 2012, the SCCS recommended adding 56 new allergens to the current list of 26 allergens with the requirement for separate labeling in the ingredients. There are several drawbacks to this, including the additional burden it places upon the sector, and the creation of ‘crowded’ ingredient’s lists. In addition, regulators are currently unsure of the feasibility of accurately testing for all these allergens. The Commission has recently announced an impact assessment to look the different regulatory options, but no formal regulatory proposal is expected until 2019/2020.
Specific ingredients under the spotlight
Stakeholders should also be aware of specific substances where the disparity between regulations means the legality of their use can be questioned. These include:
- Formaldehyde in nail hardeners – listed as exempt in Annex III but also as CMR Category 1B, presumed carcinogen. It has also been assessed as safe by the SCCS and complies with food safety regulations
- Titanium dioxide – authorized under Annex IV and assessed as safe by some organizations including the SCCS, has been proposed by the ECHA Committee for Risk Assessment to be classified as CMR Class 2 – suspected carcinogen by inhalation. The ECHA proposal is still pending approval from the EU Commission
- Zinc pyrithione – listed as exempt for some uses in Annex III, assesses as safe for use as anti-dandruff ingredient by SCCS, but undergoing review as potential CMR 1B for reprotoxicity
- Salicylic acid – Annex III exemption but ECHA is recommending CMR 2 classification, suspected reproductive toxicant
- Siloxanes D4 and D5 – currently undergoing two separate regulatory processes
- Methylisothiazolinone – Cosmetics Europe recommended discontinuing use in 2013, EU introduced restrictions in 2017
SGS solutions: helping manufacturers achieve compliance
Without harmonization between different facets of the EU regulations governing cosmetic ingredients, it can be difficult for manufacturers to be assured of legal compliance.
As the world’s leading provider of testing and certification services, SGS has the regulatory know-how to help cosmetics manufacturers achieve compliance with EU regulations. Our experts can help you stay ahead of regulatory changes, ensuring your products can be successfully marketed in the 28-member states, giving access to over 500 million potential customers.
For more information, please contact:
Consumer and Retail Sales Engineer
Cosmetics, Personal Care and Household
t: +33 1 41 24 86 62