Fragranced products are required to be classified, and if hazardous, labelled according to the Classification, Labelling and Packaging (CLP) Regulation, unless covered by other sectoral legislation. Gill Pagliuca looks at what types of hazards may be present in these products, what sort of information may be needed for classification, and at some of the issues that suppliers may face when labelling these products.
Many suppliers of fragranced products are not aware that their products are in scope of the CLP Regulation, and may be classified as hazardous and consequently require labelling. This may be because they deal primarily with products regulated under other legislation such as foods and cosmetics and only supply a few household items such as fragranced candles or room sprays. Items such as candles are also often not thought of as chemical products, however, under both the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and CLP Regulations they are considered to be a combination of a carrier article (the wick) and a mixture (the wax, fragrance, colouring and any other additives). There is also a commonly held belief that because fragrances are often natural in origin they are not hazardous or not subject to regulation.
In fact, CLP applies to all substances and mixtures placed on the market, unless covered by more specific sectoral legislation such as cosmetics, medicines or food regulations; and any substance or mixture placed on the market must first be assessed to see if it is hazardous, and if it is found to be so it must be labelled according to the requirements of CLP.
Fragrances, both synthetic and natural, may possess a range of different hazards. Sensitisation (the ability to cause an allergic reaction) is a particular issue for fragrances because of our frequent exposure to them in cosmetics, toiletries, laundry products and so on that may be in repeated and prolonged contact with our skin; and many fragrances are classified as sensitisers. Other types of hazards often found in fragrance substances include skin and eye irritants, and hazards to the aquatic environment. A few have been found to possess severe chronic hazards such as carcinogenicity and reproductive toxicity and are severely restricted for use. Fragrances in products such as room sprays and reed diffusers are also often mixed with solvents which may bring additional hazards such as flammability in the case of alcohols and aspiration toxicity in the case of base oils.
Natural fragrances are often very complex mixtures of substances, and the amount of hazardous component substances in a natural fragrance may vary considerably. It is usually necessary to get a breakdown of the component substances in a natural fragrance from the fragrance supplier in order to classify products accurately. Typical compositions for common fragrances may also often be found in academic publications and other internet sources, however, a specific breakdown from the supplier is always better than a generic composition plucked from elsewhere. Without a detailed breakdown it is easy to over classify mixtures if using ingredient based approaches as the hazardous components are often a relatively small component of the fragrance. Hazard assessment may often be a lot easier if using synthetic fragrances which are much simpler and better characterised, though these may be perceived as less attractive to customers.
Most fragrance suppliers will be happy to supply documents such as typical concentrations for the list of 26 allergens in Annex III of the EU Cosmetic Regulation 1223/2009. Safety Data Sheets (SDSs) in section 3.2 will also contain details of the main hazardous components.
The “list of 26” represents the most common allergens known to cause adverse effects back when it was first created in the 1990s, however, many more fragrance substances are now known or suspected to be sensitisers. Proposals that will require the identification of many of these additional sensitisers are currently being considered by the European Commission, and the list of 26 substances may soon turn into a list of 90 or more substances.
Under CLP, all known sensitisers present above classification thresholds in fragranced products will need to be identified if present above the induction or elicitation thresholds. See the recent feature article Understanding and identifying sensitisers for an explanation of these thresholds and labelling requirements.
If fragranced products are classified as hazardous the products will need to be labelled. Where to place labels on home fragrance products is a topic that has provoked some discussion. The rules in CLP are very clear — labels should be firmly affixed to the product and should be readable when the product is set down normally. For a product such as a can of air freshener this is not generally an issue but for products like fragranced candles and reed diffusers where the aesthetic appearance is important, this can be more problematic. There is also a risk that consumers will remove what they perceive as unattractive labels for products to be displayed around the home. Some suppliers have looked at using labels that can be easily peeled off after the customer has read them, however, CLP requires labels to be firmly affixed and not easily peeled off. In practice, it is also quite difficult to firmly stick a label to a wax candle. Solutions such as tie-on-tags may be useful but can also easily be removed. Some suppliers consider that base labels are less likely to be removed from these products, but these do not meet the requirement to be readable when set down normally. It remains to be seen how enforcement authorities will view the use of base labels.
Another issue for hazard labels for fragranced products is the selection of names when identifying hazardous components in accordance with Article 18(3). CLP labelling rules generally specify the use of complicated chemical names (the EC or IUPAC names) for preference, though other internationally recognised names are also permitted such as the INCI names used for cosmetics and toiletries. Is it better for consumer recognition and understanding if a hazardous component is identified as the natural fragrance, for example lavender oil, or is it better to identify the actual hazardous component(s) of the oil, such as linalool? The purpose of a label is to communicate, so careful consideration should be given to not just regulatory compliance but also to selecting names that consumers are most likely to be aware of when identifying products that they may be sensitive to.
Hazardous products may not be supplied to the public unpackaged, except for a few specified products (wet cement and concrete). This means that products such as candles and candle melts cannot be sold loose and unpackaged. They must be placed in a bag or box, or wrapped in cellophane, etc. When designing labels and packaging, suppliers should also take care to meet the requirements of Article 35(2) that packaging containing a hazardous substance or a mixture supplied to the general public should not have either a shape or design likely to attract or arouse the active curiosity of children or to mislead consumers, or have a similar presentation or a design used for foodstuff, animal feeding stuff, medicinal or cosmetic products, which would mislead consumers. Particular care may be needed with items such as novelty shaped candles and candle melts to avoid, for example, using pictures of foods that evoke the fragrances used and that may encourage small children to nibble on them.
Finally, SDSs will also be required for hazardous fragranced products if they may be used in a workplace setting, and may also be requested by employers even if products are packaged for retail sale, for example, where exposure may occur in staff in a hotel setting out these products in guest rooms, or shop workers setting out displays of products.
Last reviewed 2 March 2016