WRITTEN QUESTION E-2126/02 by Chris Davies (ELDR) to the Commission. Fragrance allergens.
Date: 2002-07-17
Institutions: European Parliament, Provisional data
Subjects: chemical product, consumer information, cosmetic product, report, scientific committee (EU), skin disease

C 28 E/190

Official Journal of the European Union

EN

6.2.2003

Joint answer
to Written Questions E-2123/02 and E-2124/02
given by Mr Fischler on behalf of the Commission

(5 August 2002)

As the Honourable Member rightly stated, the principle of relative stability has been referred to in
Community legislation. However, that legislation does not contain the elements necessary to make fully
transparent how the principle of relative stability works in practice. The Commission proposes that these
elements are laid down in a Regulation by Council, in consultation with Parliament. The Commission is
convinced that legal security will be increased in this manner.

(2003/C 28 E/216)

WRITTEN QUESTION E-2126/02

by Chris Davies (ELDR) to the Commission

(17 July 2002)

Subject: Fragrance allergens

On 8 December 1999, the Scientific Committee on Cosmetic and Non-Food Products (SCCNFP) adopted
an opinion on fragrance allergy compounds. It does not discriminate between synthetic and natural
fragrance compounds.

A report in TNO Bibra Bulletin 2001, 40, 71 draws attention to the work of Orton D.I. and Shaw S.
(2001) Contact Dermatitis 44, 190 who looked at the components of the standard diagnostic ‘fragrance
mix’, used to determine if patients with allergic contact dermatitis have fragrance allergy. The authors
found that positive reactions were caused in 14 patients between 1982 and 2000 to both the mix and to
the sorbitan sesquioleate emulsifier used to disperse the odorants. The conclusion was that only two of the
patients of the 14 identified could be considered sensitised to one of the odorants in the mix.

It may be that the other 12 reactions were caused by the sorbitan sesquioleate emulsifier rather than the
fragrance mix.

This study, amongst others (Frosch PJ et al. 1995a and 1995b), appears to cast doubt on allegations
elsewhere about problems associated with fragrance allergens.

Did the SCCNFP take this evidence into account when drawing up its opinion?

Will there be any further investigation into this issue, which is clearly not resolved in the SCCNFP opinion?

Answer given by Mr Byrne on behalf of the Commission

(24 September 2002)

As the SCCNFP issued its opinion on fragrance allergy in consumers on 8 December 1999, it did not
consider the report in TNO Bibra Bulletin 2001. The Committee’s opinion is supported by an extensive
bibliography; in any case, the Commission will draw the Committee’s attention to the TNO report.

In its opinion, the SCCNFP does not discriminate between synthetic and natural compounds as there is no
difference in allergenicity between a chemical compound synthetically produced or extracted from a
natural product.

The aim is that information should be provided to consumers about the known presence in cosmetic
products of fragrance ingredients with a well-recognised 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.

6.2.2003

EN

Official Journal of the European Union

C 28 E/191

A fragrance ingredient is defined by the International Fragrance Association (IFRA) as any basic substance
used in the manufacture of fragrance materials for its odorous, odour-enhancing or blending properties.
Fragrance ingredients may be obtained by chemical synthesis from synthetic, fossil or natural raw materials
or by physical operations from natural sources.

Sorbitan sesquioleate is used as an emulsifier in the standard diagnostic ‘fragrance mix’. It is known to be a
very rare allergen. Individuals shown to react to the fragrance mix will be tested to the individual eight
fragrance components of the mix and also to the sorbitan sesquioleate. The individual tests do not require
the emulsifier. There are papers showing that, sesquioleate is not an important factor. It was fully debated
at least 10 years ago.

Therefore, the assumption that ‘the other 12 reactions may have been caused by the sorbitan sesquioleate
emulsifier rather than the fragrance mix’ is not relevant to the problem of fragrance allergy.

(2003/C 28 E/217)

WRITTEN QUESTION P-2157/02

by María Rodríguez Ramos (PSE) to the Commission

(11 July 2002)

Subject: ERDF funding for the destruction of three medieval water mills

The work involved in executing the project ‘measures affecting various stretches of the river Duero’, partly
funded by the ERDF, has led to the unjustified and unsupervised demolition of the water mills of Cabañales
(Zamora). These buildings feature in the above-mentioned project, according to which they were supposed
to be restored and converted to house nature study centres.

The public prosecutor at the Zamora Provincial Court has initiated proceedings and Zamora town council
has ordered that the work be suspended.

Irrespective of the measures being carried out in the Member State concerned, and taking into account the
harm done to the Commission’s image by a project receiving European funding being executed in a
manner contrary to that intended, does the Commission intend to impose any kind of sanction on those
responsible for this aggression against the cultural heritage, once it has been established who they are?

Answer given by Mr Barnier on behalf of the Commission

(12 August 2002)

According to information received from the Spanish authorities, the project ‘Actuaciones en varios tramos
del río Duero, Zamora’ is included for co-financing at 70 % by the European Regional Development Fund
under measure 6 (Protection and regeneration of the natural environment) of the third priority of the
Integrated operational programme Castilla y León for the 2000-2006 programming period.

The Spanish environmental authorities competent in the area have certified that the works do not affect
any site classified as a Natura 2000 protected area and that this project is not required to follow an
Environmental Impact Assessment procedure.

The project has been the subject of a complaint for possible incorrect application of Community legislation
relative to the assessment of the effects of certain public and private projects on the environment. Where
the Commission identifies any breach of Community legislation regarding the development of the project,
it will take the appropriate measures. These include a possible suspension of financial support for the
project as long as all the legal requirements are not met.