Beyond the Cosmetics Regulation: Substances of Concern
What we learnt from auditing beauty brands on their readiness for European Green Deal compliance
The European Green Deal is reshaping the regulatory landscape for the cosmetics industry, presenting both challenges and opportunities. It will impact all stages of cosmetic production from ingredient sourcing, formula development all the way through to claims and packaging. One crucial concept to be aware of is ‘Substances of Concern’ (SoCs) which will strongly affect cosmetic products, packaging and other beauty articles. These substances are defined in the recently adopted Ecodesign for Sustainable Products Regulation (ESPR) and are a key focus of the European Green Deal’s Chemicals Strategy for Sustainability. But why is this important for cosmetic brands? Let’s explore
Firstly, what are substances of concern?
It is not the first time that our industry is introduced to the term substances of concern. Under REACH Regulation (please add full title) article 57, substances that may have serious and often irreversible effects on human health and the environment can be identified as substances of very high concern (SVHCs). If a substance is identified as an SVHC, it is added to the Candidate List for eventual inclusion in the Authorisation List. The scope of substances of concern under the EPSR include SVHCs but the scope is broader. This could therefore be a bit confusing for EU companies but even more for non EU companies.
Substances of concern are defined in the EPSR as a substance that:
SVHC under EU REACH
specific hazard categories under the CLP Regulation (e.g. CMR, PBT, vPvB, STOT)
'POP' substances
negatively impacts reuse or recycling
The full definition can be found in the ESPR Regulation.
Why do I need to know if my product or its packaging contains SoCs?
The main objective of the Sustainable Product Initiative (SPI) implemented via the ESPR is to reduce the negative life cycle environmental impacts of products and improve the functioning of the internal market, while benefiting from efficient digital solutions.
Transparency
All regulated products will be required to have Digital Product Passports (DPP). This will make it easier to repair or recycle products and facilitate tracking substances of concern along the supply chain. A key aspect of the ESPR is the requirement for businesses to track and disclose the presence of SoCs throughout the product lifecycle. The introduction of the DPP will mandate detailed ingredient reporting, making supply chain transparency more critical than ever. Cosmetic brands must work closely with suppliers to ensure accurate data collection and regulatory compliance. We have been asked frequently if a threshold will apply to this requirement. Although we are lacking certainty on that topic today, potential thresholds or exemptions may be established under future category-specific delegated acts.
Minimisation
Another key aspect to keep in mind is the obligation to minimise the use of those SoCs. In particular, the Packaging and Packaging Waste Regulation provisions impose a minimisation obligation for packaging manufacturers in relation to the SoCs. We may not forget that the end game is for those substances of concern to be phased out in the long run..
(d) negatively affects the reuse and recycling of materials in the product in which it is present
Although the scope of substances falling in the scope of (a), (b) and (c ) is overall commonly identified by the industry and the REACH and CLP Regulations, entry (d) is a new challenge.
ECHA was mandated earlier this year to support the European Commission by preparing a study identifying chemicals of concern in packaging and related components assessing how these chemicals affect their safety, reuse and recycling. We are expecting ECHA to provide its input to the Commission by the end of September 2026.
What did we learn from our EGD audits?
From our audits of beauty brands assessing their readiness for European Green Deal compliance, we observed as expected a significant gap in SoC preparedness. Many brands were not aware of the presence of SoCs in their products, and suppliers struggled to provide the necessary compliance statements. Some of the challenges of course is the lack of clarity on the pool of the SOCs in particular for packaging. Whilst the Regulation is not yet implemented, this lack of readiness underscores the need for brands to enhance their regulatory strategies, strengthen supplier collaboration, and implement robust tracking systems to ensure compliance with upcoming legislation. Although some clarity is still needed for full compliance in the future a robust system needs to be implemented now to ensure compliance on day 1.
How we can help
Bloom Regulatory is pleased to offer services relevant to the packaging used for cosmetic products and to assist our customers in determining compliance with not only the requirements of the Cosmetics Regulation but the wider remit of the European Green Deal in the EU. Get in touch today to see how we can support you and your beauty business.
Laila Manshi