Allergenic fragrances in cosmetics sold as “perfume-free”: the EDQM report

Between 2018 and 2019, the European Network of Official Cosmetics Control Laboratories (OCCLS) conducted a survey on cosmetics’ compliance with label and claim requirements, in particular the ones concerning allergenic fragrances. The related report was published on December 15, 2020 by the European Directorate for the Quality of Medicines & Healthcare (EDQM) of the Council of Europe.

The report

932 samples, manufactured in 34 different countries, and collected from different stages of the distribution chain, were analyzed. 544 of these products were labelled as “perfume-free” (or similar claims).

The overall compliance of products tested was 80%, but it fell down to 59% in relation to perfumes’ analysis:

  • 7.7% of samples displayed missing or false declaration of ingredients;
  • 2.3% of samples were labelled with claims considered misleading by the Competent Authorities;
  • 3.1% of samples contained prohibited allergenic fragrances;
  • 12.7% of samples were found non-compliant for other reasons, unrelated to the allergenic fragrances’ analysis.

These results are relevant for everyone working within the cosmetic industry because, when it comes to allergenic fragrances, non-compliance is not only an issue of false claims, but also of consumers’ safety.

Moreover, the report shows how important post-market surveillance is, considering that there is no pre-market control for cosmetics. At the same time, an additional effort from both manufacturers and Responsible Persons is necessary in order to place only safe products on the EU market.

Fragrance allergens labelling

As general rule, perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ or ‘aroma’.However, Annex III to Cosmetics Regulation EU 1223/2009 provides some exceptions: 26 allergenic fragrances must be labelled, when present above the concentration of 0.001% for leave-on products and 0.01% for rinse-off products. This is because they are sensitizing substances that can trigger contact allergy and other reactions, such as asthma, dermatitis and photosensitivity.

Considering the above, the EU Commission developed a dual strategy to manage the risk associated with fragrances:

1.      Primary prevention through bans (Annex II to Cosmetics Regulation EU 1223/2009) and concentration limits for fragrances likely to cause an allergy for a significant number of people;

2.      Secondary prevention, which aims to provide allergic consumers (meaning already sensitized people) with information about allergenic fragrances inside products, so that they can responsibly choose what to buy: this is the reason  behind labelling requirements.

In conclusion, the EU legislative framework aims to ensure both the consumers’ safety (health protection) and the consumers’ right to information.

An ongoing process

Because of the potentially high risk for human health, further changes to the regulatory framework concerning allergenic fragrances are expected: for several years, already, these substances have been under scrutiny from both Competent Authorities and scientific committees.

For example, following a public consultation that took place between 2019 and 2020, this year the EU Commission is going to adopt a decision on the possibility of adding 62 more substances to the list of allergens to be mandatory labelled.

Francesca Santacatterina

Regulatory Affairs Department


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