EU and Idea Project Improve Industry Understanding of Fragrance Allergens
Allergenic fragrances are under the spotlight as Europe’s IDEA project seeks to build on SCCS recommendations on the individual labelling and prohibition of certain natural and synthetic substances in cosmetic products.
Skin allergies may be caused by the presence of certain substances, both synthetic and natural, in fragrances contained in cosmetic products (perfumes, creams, deodorants). Indeed, the European Commission (EC) estimates that between 1% and 3% of Europe’s population is affected by skin allergies to fragrances in cosmetic products. Sufferers typically, experience symptoms including irritation, swelling and/or a rash, but they may develop into a chronic condition (eczema).
Once triggered, an allergy is a lifelong condition. The symptoms will re-appear if the person is exposed to the same substance again.
WHAT ARE FRAGRANCE ALLERGENS?
Since 2003, 26 fragrance allergens have had to be identified on the label of consumer products, to help inform end-users of the presence of substances to which they are sensitised. Following research by the EC’s Scientific Committee on Consumer Safety (SCCS), the Commission is now proposing to ban three fragrances, HICC, atranol and chloroatranol, as they can no longer be considered safe. Since 1999 there have been about 1,500 reported cases of fragrance allergy to HICC and between 100 and 1,000 cases for each of the other two substances (atranol and chloroatranol).
EU Regulation 1223/2009 on cosmetic products regulates fragrance allergens. Those that are restricted or banned are listed in Annex II, or Annex III, respectively.
FRAGRANCE ALLERGEN REVIEW
In 2012, the SCCS completed a review of fragrance allergens in cosmetics products, the first review of this category since 2003, which covered skin (also called: contact) allergens, not respiratory allergens. As a result of the review, the SCCS found that:
- 3 allergens (HICC, atranol and chloroatranol) were recognized as ‘potent allergens’ and were no longer considered safe in cosmetic products.
- 82 substances can now be categorised as ‘established contact allergens’, including the 26 that were already on the list.
- 26 individual chemicals can be categorised as ‘likely contact allergens’.
- 48 chemicals (including 13 natural extracts) can also be categorised as ‘possible contact allergens’.
The SCCS recommended that all these substances be added to the list of allergenic ingredients that must be included on the labelling of consumer products. The EU cosmetics regulation 1223/2009 may be amended with the aim of protecting consumers against fragrance allergens while taking into account the social and economic impact of these measures on the European fragrance industry.
The Commission’s proposal, taking into account the results of the public consultation as well as comments from the authorities of the Member States, manufacturers of cosmetic products, consumers associations (by 14 May 2014), will be voted on by the Member States in the standing committee on cosmetics. The amendments could be formally adopted at the end of 2014 or the beginning of 2015.
The SCCS opinion on fragrance allergens, delivered in 2012, was a real eye-opener for the cosmetics industry. It highlighted a communication gap between the regulators, manufacturers and the supply chain, and consequently, a huge knowledge gap on fragrance allergens, specifically how to characterise, assess and diagnose them.
To address this gap, the International Fragrance Association (IFRA) developed a work plan of what should be done to improve the risk assessment of fragrance allergens and submitted it to the EU. Endorsed by Tonio Borg, EU Minister for Health, the plan, now known as the International Dialogue for the Evaluation of Allergens (IDEA project), is a multi-stakeholder process designed to provide a broadly agreed and transparent framework for assessing fragrance sensitisers.
IDEA consists of a series of workshops bringing leading international scientists together to reach consensus on improving existing methodologies. Recommendations made during workshops are then developed through industry or research projects. Annual reviews monitor and validate the project’s progress and are used to define the project’s future actions.
EU COSMETIC REGULATION COMPLIANCE
SGS is experienced in enabling organisations to demonstrate their compliance with the EU cosmetics regulation. We conduct tests and safety assessments to ensure that cosmetics products are safe to be placed on the market and comply with all relevant national and international regulations.
With a network of experts and testing facilities across the EU, America and Asia, SGS is the partner to trust.
For more information, please visit SGS cosmetic website or contact our team:
Global Technical Manager – Cosmetics,
Personal Care and Household
t: +33 4 42 61 64 91
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.