Invited to open the discussion, Patricia de Nicolaï, an independent perfumer and the current president of the Osmothèque, the International Conservatory of Perfumes, reminded how perfumery is an important patrimonial heritage in France. While we can trace its origins to the Renaissance, the perfumes and cosmetics sector is also a strong reality in today’s France where it is the third largest net exporter of the French industry. Furthermore, it is composed of 81% of SMEs.

Frederic Lebreux (IFRA) presented the QRA method and the IDEA project...

Frederic Lebreux (IFRA) presented the QRA method and the IDEA project (International dialogue for the evaluation of allergens)

Having invested heavily to adapt their processes to the new requirements of the European Cosmetic Regulations [1], the perfume industry is now worrying about the possible consequences of a regulatory environment that has considerably tightened.

Substances under surveillance

Michèle Elbaz, Delegate Director Regulation and Safety at Chanel, has reviewed the perfume substances whose legal status is under review whether in application of the Cosmetics Regulation or in application of REACH.

Some of these substances correspond to series for which the European Commission questioned the Scientific Committee [2] some years ago and which are still under discussion, waiting for regulatory measures (Tagetes minuta, patula; Methyl -N -methyl anthranilate; Vetiveryl acetate; Acetaldehyde).

Some substances also fall under the scope of Article 15 of the Regulation on cosmetic products, which prohibits the use of CMR substances classified in category 1A (known CMR effect on humans), 1B (Suspected CMR effect on humans) or 2 (suspected CMR effect, but the available information is insufficient).

Furthermore, some substances are also impacted by some additional REACH procedures besides registration, namely Substance Evaluation and Harmonized Classification and Labelling. This is the case, for example, of BMHCA, Furfuryl alcohol, Citral and Citronellal. "However, this does not necessarily mean that these substances are about to be prohibited or restricted," said Michèle Elbaz. Indeed, the deadline of their assessment may be delayed, depending on priorities, or they may be removed from the list if their REACH dossier has been fulfilled.

However, the situation for the fragrance industry could become even more complex. Indeed, REACH procedures are currently very focused on CMR but should be massively expanded to include sensitizing and endocrine disruptors. "The challenge will be to demonstrate that the risk posed by skin sensitizers is sufficiently managed by the Cosmetics Regulation and the Regulations for the protection of workers, and that skin sensitizers cannot be treated a as CMRs," said Michèle Ebaz.

Allergen substances

Florian Schellauf, Issue Manager at Cosmetics Europe, exposed the situation regarding the other big concern: perfumery allergens. The measures proposed by the European Commission in response to the recommendations of the Scientific Committee on Consumer Safety (SCCS) are currently subject to public consultation. The Commission is pursuing two main goals: to prevent induction (the onset of allergies), and to prevent elicitation (the trigger of allergic reactions among sensitized individuals). The Commission therefore proposed to prohibit certain substances, to restrict the concentration of a series of others, and to add many substances to the list of allergens that must be labelled.

"In this context, Cosmetics Europe is proposing a series of solutions which, while being very pragmatic, will ensure that consumers be properly informed," says Florian Schellauf. In particular, Cosmetics Europe suggests that companies may chose to label the list of allergens on the package or to provide this information electronically. A logo (left) could inform concerned consumers that the information they need is available online.

The general revolution of providing information in electronic format has progressed in such a manner that a majority of consumers today prefer this way of receiving information. Accessing information electronically has become a fact of life and an integral part of society”, said Florian Schellauf.

Cosmetics Europe also supports a change in the INCI nomenclature, in order to allow abbreviations. The European Association also requested a transition period of at least 6 years for products already placed on the market.

The public consultation period on this issue will end mid-May 2014. The Commission will then submit its final proposals to the Parliament and the Council for final adoption in late 2014 or early 2015. Then perfumers will know their fate.