EU amendment to sharpen restrictions on fragrance allergens
10 years ago
Not quite ready to accept that nothing can be done about fragrance reformulation in the name of consumer safety, I have been reading on the IFRA and EU cosmetics regulation. I thought I share my newly acquired insights with you all. Please feel free to add, correct and comment.
The I.F.R.A. and EU legislation on cosmetic products are not the same
The IFRA (International Fragrance Association) has delighted many a fragrance connoisseur with its most recent amendment, issuing restrictions and prohibitions for meanwhile around 200 natural or synthetic ingredients of concern. Abiding by the IFRA Code of Practice is a prerequisite for all fragrance supplier companies that are members of the IFRA. Some non-members choose to comply with it nonetheless. Not doing so is "difficult to sustain in the EU because of the need for safety assessments and in the US because you are likely to be sued and defending the case when you have not abided by the internationally recognised safety standards is going to be very difficult to say the least", to quote Chris Bartlett at BN.
In the EU (European Union), Regulation (EC) No 1223/2009, which had been adopted in 2009, must be fully complied with since July 2013. All companies that are either located in the EU or sell to the EU must comply with this legislation.
It is required that 26 fragrance allergens must be indicated in the list of ingredients when its concentration exceeds 0.001% in leave-on products, e.g. perfumes, and 4 fragrance ingredients are restricted to certain levels. Whether or not this is grounded on up to date scientific research is debatable. Quite a number of papers have been published that question the EU's "26 allergens" legislation. For a summary refer to Cropwatch Claims Victory Regarding "26 Allergens" Legislation (or, in a broader context, to Negative Bias, an article published in Personal Care). However, up until now EU legislation on cosmetic products is significantly less rigorous than the IFRA code.
If the EU's "26 allergens" legislation is disputable, will the pending bill acknowledge and adjust to this?
No, it won't. In 2012, the SCCS (Scientific Committee on Consumer Safety), an independent advisory body to the Commission, produced an opinion, the "Opinion on fragrance allergens in cosmetic products", in which over 100 additional individual substances and natural extracts have been identified as established or likely contact allergens. The SCCS also identified primary and secondary prevention measures, from prohibition to information, that could limit or eliminate exposure to fragrance allergens. For an overview of the opinion, refer to the SCCS's online presentation.
What is the problem with labeling?
Clearly most consumers would favour declaration over prohibition/restriction. EU legislation pushes for transparency of ingredients in consumer products. This, however, puts considerable pressure on the fragrance industry for the following reasons. Most SME's (small and medium-sized enterprises) fear they will not be able to stand the cost that extensive declaration entails, which threatens to put them out of business.
Furthermore, there is no sufficient legal ground to claim intellectual property of a fragrance formula. The IFRA expressed this dilemma for instance in this article: "Products such as (...) fine fragrances all contain a fragrance formula" but "legally it is considered as 'artisanal' and therefore cannot be protected. Because of this, historically the fragrance industry has closely guarded the secrets of its formulae".
What does this imply for perfumery?
Implementing the SCCS opinion without significant alteration will gravely damage perfumery because it restricts the panoply of scent severely. According to IFRA estimate, some 9,000 perfumes would have to be reformulated if their production is not ceased entirely. "If this law goes ahead I am finished, as my perfumes are all filled with these ingredients," said Frederic Malle. The impact on luxury perfume brands as a whole would, he said, be "like an atomic explosion and we would not have the means to rebuild ourselves."
Status of the amendment
Public consultation commence in February 2014. Taking the consultations on fragrance allergens into account, the proposed changes to the Cosmetics Regulation will be subject to a vote by the Member States in the standing Committee on Cosmetics. Once the measures are approved by the Member States, the European Parliament and the Council will have three months to exercise their right of scrutiny. If the proposal is not opposed, the formal adoption of those changes is expected at the end of 2014/beginning 2015.
What can be done?
There are two ways to fight a pending bill. Petition/collection of signatures and provision of a letter template with a well-conceived argument as to why consumers oppose it. I doubt it would be without any effect on the decision of the representatives in Council and Parliament, if a significant number of fragrance lovers from the EU were to get in touch with their reps and voiced their stance. After all, one can surely assume that re-election is in their interest.
Update, February 13, 2014
The European Commission propose that:
1. The three substances which were found to be unsafe should be banned from cosmetic products,
2. Additional allergens should be subject to the obligation of individual labelling on the package of a cosmetic product. In other words, they have to be mentioned in the list of ingredients, in addition to the words 'parfum' or 'aroma'.
For further details please refer to Public consultation on fragrance allergens.
The I.F.R.A. and EU legislation on cosmetic products are not the same
The IFRA (International Fragrance Association) has delighted many a fragrance connoisseur with its most recent amendment, issuing restrictions and prohibitions for meanwhile around 200 natural or synthetic ingredients of concern. Abiding by the IFRA Code of Practice is a prerequisite for all fragrance supplier companies that are members of the IFRA. Some non-members choose to comply with it nonetheless. Not doing so is "difficult to sustain in the EU because of the need for safety assessments and in the US because you are likely to be sued and defending the case when you have not abided by the internationally recognised safety standards is going to be very difficult to say the least", to quote Chris Bartlett at BN.
In the EU (European Union), Regulation (EC) No 1223/2009, which had been adopted in 2009, must be fully complied with since July 2013. All companies that are either located in the EU or sell to the EU must comply with this legislation.
It is required that 26 fragrance allergens must be indicated in the list of ingredients when its concentration exceeds 0.001% in leave-on products, e.g. perfumes, and 4 fragrance ingredients are restricted to certain levels. Whether or not this is grounded on up to date scientific research is debatable. Quite a number of papers have been published that question the EU's "26 allergens" legislation. For a summary refer to Cropwatch Claims Victory Regarding "26 Allergens" Legislation (or, in a broader context, to Negative Bias, an article published in Personal Care). However, up until now EU legislation on cosmetic products is significantly less rigorous than the IFRA code.
If the EU's "26 allergens" legislation is disputable, will the pending bill acknowledge and adjust to this?
No, it won't. In 2012, the SCCS (Scientific Committee on Consumer Safety), an independent advisory body to the Commission, produced an opinion, the "Opinion on fragrance allergens in cosmetic products", in which over 100 additional individual substances and natural extracts have been identified as established or likely contact allergens. The SCCS also identified primary and secondary prevention measures, from prohibition to information, that could limit or eliminate exposure to fragrance allergens. For an overview of the opinion, refer to the SCCS's online presentation.
What is the problem with labeling?
Clearly most consumers would favour declaration over prohibition/restriction. EU legislation pushes for transparency of ingredients in consumer products. This, however, puts considerable pressure on the fragrance industry for the following reasons. Most SME's (small and medium-sized enterprises) fear they will not be able to stand the cost that extensive declaration entails, which threatens to put them out of business.
Furthermore, there is no sufficient legal ground to claim intellectual property of a fragrance formula. The IFRA expressed this dilemma for instance in this article: "Products such as (...) fine fragrances all contain a fragrance formula" but "legally it is considered as 'artisanal' and therefore cannot be protected. Because of this, historically the fragrance industry has closely guarded the secrets of its formulae".
What does this imply for perfumery?
Implementing the SCCS opinion without significant alteration will gravely damage perfumery because it restricts the panoply of scent severely. According to IFRA estimate, some 9,000 perfumes would have to be reformulated if their production is not ceased entirely. "If this law goes ahead I am finished, as my perfumes are all filled with these ingredients," said Frederic Malle. The impact on luxury perfume brands as a whole would, he said, be "like an atomic explosion and we would not have the means to rebuild ourselves."
Status of the amendment
Public consultation commence in February 2014. Taking the consultations on fragrance allergens into account, the proposed changes to the Cosmetics Regulation will be subject to a vote by the Member States in the standing Committee on Cosmetics. Once the measures are approved by the Member States, the European Parliament and the Council will have three months to exercise their right of scrutiny. If the proposal is not opposed, the formal adoption of those changes is expected at the end of 2014/beginning 2015.
What can be done?
There are two ways to fight a pending bill. Petition/collection of signatures and provision of a letter template with a well-conceived argument as to why consumers oppose it. I doubt it would be without any effect on the decision of the representatives in Council and Parliament, if a significant number of fragrance lovers from the EU were to get in touch with their reps and voiced their stance. After all, one can surely assume that re-election is in their interest.
Update, February 13, 2014
The European Commission propose that:
1. The three substances which were found to be unsafe should be banned from cosmetic products,
2. Additional allergens should be subject to the obligation of individual labelling on the package of a cosmetic product. In other words, they have to be mentioned in the list of ingredients, in addition to the words 'parfum' or 'aroma'.
For further details please refer to Public consultation on fragrance allergens.
Last edited by MiaTrost on 21.02.2014, 18:42; edited 65 times in total