Introduction

In the last years, several new European Regulations and Directives have been adopted or announced in relation to flavors and fragrances. As essential oils and extracts are very important ingredients for flavoring and fragrance applications, these new regulations will have a major impact on the trade and use in commerce of these essential oils and extracts.

This chapter will focus on some pieces of legislation that are of major importance for the Flavour and Fragrance (F&F) Industry, such as the Cosmetic Directive 76/768/EC and especially its Seventh Amendment (2003/15/EC) and the first amendment of the Detergent Regulation (June 2006), which make the labeling of 26 specific fragrance ingredients (the so-called 26 "alleged" allergens) mandatory: the presence of these materials above the given threshold has to be declared irrespective of the way they are added (as such or as being part of "complex ingredients" such as extracts and essential oils).

Some attention will be paid to the new Flavouring Regulation (part of the so-called Food Improvement Agents Package) that will replace the current Flavouring Directive 88/388/EEC and that is currently under discussion at the EU Commission, EU Parliament and Council levels.

Also the issue of hazard classification and labeling of dangerous substances and preparations, and essential oils containing hazardous components will be addressed and some examples will be given. This relates to the recent publication of the Commission Directive 2006/8/EC amending the Dangerous Preparations Directive 1999/45/EC.

22.2 COSMETIC AND DETERGENT LEGISLATION AND ALLERGEN LABELING 22.2.1 History and Background

In recent years (the late 1980s and 1990s), there has been a scientific debate on the safety of fragrance (perfumery) ingredients. Dermatologists have highlighted the risk of contact allergy from fragrance ingredients (Santussi et al., 1987; Becker et al., 1994), and actions to prevent the disease have been requested (Frosch et al., 1995; Larsen et al., 1996; SCCNFP 0017/98).

As a result of this and in response to a question from a Member State (MS) and members of the European parliament, the Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers (SCCNFP) has been asked by DG Enterprise (EU Commission) to respond to the following mandate in relation to the safety of fragrance ingredients and to answer (among others) the following questions:

• It is proposed that all known fragrance allergens are labeled on cosmetics if used in the products. Does the SCCNFP agree to this proposal? If so,

- Which chemicals fall under this classification?

- Is there a maximum concentration of each chemical permissible without the requirement for labeling?

• Restrictions are proposed for the three most common fragrance allergens (cinnamic aldehyde, isoeugenol, and hydroxycitronellal). Does the SCCNFP agree to restriction on the use of common fragrance allergens (Annex III listing)? If so

- Which fragrance materials should be subject to restrictions?

- What are the conditions for restrictions (maximum concentration, fields of applications, etc.)?

Other questions were related to industry-restricted and industry-prohibited substances.

In its Interim position on Fragrance allergy SCCNFP/0202/99 adopted at the SCCNFP session of June 23, 1999, the SCCNFP already stated: "Contact allergy to fragrance substances is an important clinical problem. Up to 10% of individuals with eczema are allergic to fragrance substances and possibly 1-2% of the general population."

In the same Interim position, SCCNFP considered that the mandate from the European Commission could be usefully divided into the following two sections:

1. Identification of those fragrance ingredients that are of concern as allergens for the consumer. Recommendations on informing the consumer of the presence of important allergens to permit the consumer with a known fragrance allergy as a means to avoid contact with an allergen. An opinion as to whether such an identification can be related to concentrations present in a product when elicitation levels are known.

2. An opinion on the adoption of industry-prohibited substances into Annex 2 and adoption of industry-restricted substances into Annex 3. Consideration as to whether the concentration limits or other restrictions suggested by industry can be supported or need to be changed if there is such an inclusion in Annex 22.3. Whether there are additional substances that should be subject to inclusion in an annex.

Taking into account the importance and enormity of the mandate, it was concluded that the first section should be considered initially.

As a result, the SCCNFP published, as a follow-up to the Interim position, its opinion SCCNFP/0017/98 (adopted by the SCCNFP during the plenary session of December 8, 1999) entitled "Fragrance allergy in consumers—A review of the problem: Analysis of the need for appropriate consumer information and Identification of consumer allergens."

This opinion relates to the first section mentioned above and consists of

- A critical review of the problem of fragrance allergy in consumers.

- Identification of those fragrance ingredients that are well recognized as consumer allergens.

- An opinion as to whether such identification can be related to concentrations present in a product when elicitation levels are known.

Allergy to natural ingredients (such as oakmoss) was not addressed in this opinion but was analyzed separately (see SCCNFP opinion of October 24, 2000).

It was the opinion of the SCCNFP that

- Fragrance ingredients have to be considered as an important cause of contact allergy.

- Based on criteria restricted to dermatological data reflecting the clinical experience, it was possible to identify 24 fragrance ingredients, which correspond to the most frequently recognized allergens. Thirteen of these have been reported more frequently; these are well-recognized contact allergens in consumers and are thus of most concern; 11 others are less well documented.

In the opinion (SCCNFP/0017/98), two lists were given: a List A with 13 fragrance chemicals, which according to existing knowledge, are most frequently reported and well-recognized consumer allergens, and a List B with 11 fragrance chemicals, which are less frequently reported and thus less documented as consumer allergens.

Tables 22.1 and 22.2 review the substances of Lists A and B.

In addition, the SCCNFP stated in its opinion that information should be provided to consumers about the known presence in cosmetic products of fragrance ingredients with a well-recognized potential to cause contact allergy: "Information regarding these fragrance chemicals should be given to consumers if deliberately added to a fragrance formulation either in the form of a chemical or as an identified constituent of an ingredient."

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