ECA position on the BfR opinion from 11 November 2013 on lead, nickel and allergenic scents in candles to be restricted

On 24 January 2014, the German BfR (Federal Institute for Risk Assessment) published an opinion on lead, nickel and allergenic scents in candles to be restricted (BfR opinion No 004/2014, 11 No-vember 2013). The European candle industry, represented by AECM, A.I.S.E. and ECA, questions the scientific basis of BfR´s opinion with regard to all three substances or groups of substances.

This document only addresses the part of BfR´s opinion that recommends a stricter regulation for the use of fragrance ingredients with skin sensitizing properties in candles. A separate document will address BfR´s opinion on lead and nickel in candles.

First, the fact that inhalation of skin contact allergens under normal and even extreme conditions of product use could result in a ‘flare up’ of allergic contact dermatitis in previously sensitised indi-viduals is particularly questionable. The reference provided as supporting evidence is a publication by Axel Schnuch. However, in this publication it is clearly demonstrated that those ‘flare ups’ were only observed at very unrealistic exposure conditions and that the respective patients did not show any symptoms when exposed to potential real life worst case exposure situations. We therefore feel that the study conducted by Axel Schnuch does not support the conclusions drawn in the BfR opinion.

Furthermore, the BfR conclusions are driven by hazard considerations, and mixes prevention of induction with prevention of elicitation. The prevention of induction of skin sensitization is cur-rently already accomplished through the definition of safe use levels of fragrance ingredients, which are identified in a globally accepted and recognized risk management system - namely the IFRA Standards. The prevention of elicitation in previously sensitized people is generally accom-plished by avoiding the use of products which contain the ingredient to which they are allergic. Attempting to regulate candles for the general population based on a small subset of the popula-tion which is already protected by other mechanisms appears disproportionate.

The BfR opinion refers in several instances to ‘a meeting of experts’ (reference 11 of the BfR opin-ion, see reference 1) as one of the main pieces of evidence alleged to support the BfR´s point of view. Such reference is a report of views discussed at a meeting and does not constitute experi-mental evidence published in the peer reviewed scientific literature. Furthermore and more im-portantly, the concluding results of the report in question indicate that “All experts agreed that allergies caused by sprays and fragrances are not a high-priority health problem.” and that “The experts agreed that there is no recognisable necessity for any regulation beyond this [current stat-utory provisions] at this time.” and again that “…they [the experts] emphasize that they believed the statutory provisions to be sufficient.”. These statements are in contradiction with the BfR opin-ion.

It must be noted that candles - unlike toys or cosmetics - fall into the scope of the REACH Regula-tion (EC) No 1907/2006 and the CLP Regulation (EC) No 1272/2008 which guarantee the safe han-dling and use of the products for consumers. The CLP Regulation also addresses the conditions under which sensitising ingredients can be used. It specifies clear thresholds for the classification and labelling if sensitising substances are contained in candles and provides appropriate infor-mation for the minority group of people who actually are sensitive to certain ingredients whilst allowing the vast majority of people who have no problems to use the products safely.

If there was any scientific evidence that risks should be evaluated differently, then this should be addressed in the CLP Regulation for all products containing sensitising ingredients, not as a sup-plement to Directive 2001/95/EC for only a very limited number of products¹.

To conclude, consumers’ safety is a paramount priority for the European candle industry.  For the reasons stated above, the candle industry is confident that the current legislative framework provides adequate safeguards for the use in candles of fragrance ingredients with skin sensitization potential, and that introduction of additional risk management measures is not justified.

1.    English translation of the experts meeting referred to in the BfR opinion (reference 11: Schäfer, B., Platzek, T., Henkler, F., Luch, A., 2009. Bericht über ein Sachverständigengespräch "Inhalativ verursachte Allergien durch Sprays und Duftstoffe?" im Bundesinstitut für Risikobewertung (BfR). Umweltmed Forsch Prax 14 : 33-37).

¹ European Commission Decision on the safety requirements to be met by European standards for candles pursuant to the General Products Safety Directive 2001/95/EC.