Classification and labelling of scented candles

Candles are considered to be 'chemical' and as such, they are subject to CLP for classification and labelling and subject to REACH registration for import

Page updated June 2015

 

Candles

Candles caused some confusion initially regarding their definition as chemical or article, but unless purely decorative (ie contains no wick so cannot be burnt and where the primary function is not odour), these objects are now accepted to be chemicals.  ECHA guidance includes candles in examples of chemical, but has caused some confusion by describing a candle as a chemical on a carrier material; in this case, it is the wick that is the ‘carrier’.

 

Candles are also subject to a voluntary European Standard for labelling that is a requirement for most major retailers and is expected by Trading Standards in the UK and equivalent consumer production agencies across Europe.  The labelling standard is EN15494, but note that definitive publications need to be purchased. Standards also exist for sorting behaviour (EN15426) and fire safety (EN15493).  It is recommended that these standards are read and understood.

 

A key point of the Standards for candle labelling is the use of a warning triangle (preferably yellow and black), the signal word ‘WARNING’ and a set of phrases or associated pictograms.  Either the supplementary phrases or associated pictograms or can be used.  These are indicated below.


Scented candles are typically ‘mixtures’ of more than one chemical substance with the hydrocarbon wax making up the bulk of the material and small percentages of fragrances providing the odour.  Many fragrances used, especially those classed as ‘essential oils’ containing bitter citric fragrances or those based around eucalyptus will contain constituent substances that are classified as skin or perhaps respiratory sensitisers.

 

Hazardous candles

Despite some opinions to the contrary, candles are not ‘flammable’ under CLP (to be classified flammable, they would need to burn in a few seconds), but some contain fragrances classified as sensitising to the skin.  The generic concentration limit to classify a mixture is 1% sensitiser, but if present at lower levels down to 0.1%, it will need to be identified on the label.  For sensitisers considered to be high ‘potency’ under the 2nd ATP of the CLP Regulation, these limits may be lower.

 

Either way, if subject to the CLP Regulation, specific labelling requirements arise.  If classified, specific pictograms are needed with associated hazard and precautionary statements.  If not classified, but containing sensitisers above 0.1% (or lower if high potency Class 1a), then the label needs the statement ‘Contains [name of component]. May cause and allergic reaction’. 

 

If hazardous, an SDS is needed and if containing sensitisers at 0.1%, an SDS can be demanded by retailers. Annex II of REACH specifies the need to provide an SDS and specifies formatting and content; if not fully familiar with these requirements, get expert advice.

 

Although not covered by the CLP regulation or the European Standards, it is accepted that if the CLP pictogram is used to show a warning, the yellow triangle becomes superfluous; however, it is recommended to get an opinion from local inspectors and some suppliers use both pictograms.

 

Practicalities of labelling

The CLP Regulation has a special derogation for products of less than 125 ml and for products of odd shapes.  It is also worth noting that labelling needs to go on packaging and if un-packaged (ie sold loose) warnings can be communicated by other methods.  However, if selling as a loose item, it is still recommended to label, but if selling as a box of candles, the box will need to carry the label (noting a box of small candles may have a total size greater than 125 ml).

 

Many scented candles are shrink wrapped or at least have a plastic layer to retain the fragrance during storage; this is ‘packaging’. 

 

Regarding the details of labelling, it is essential to understand the CLP Regulation or get expert advice.

 

Liquid fragrances and oils

Many aromatherapy and scented liquids used for diffusers or other vehicles for delivery are hazardous either through flammability in alcohol or if in oils, then aspiration toxicity (where oil can enter the lungs and cause severe damage).  Some are also sensitising by skin contact or in certain cases, even respiratory sensitisers.  Many are environmental hazards and are only poorly biodegradable.

 

Classification is based on the concentration and the high-end products with more fragrance will perhaps be more likely to need to carry warnings on labels and will need an SDS. 

 

Small containers of less than 125 ml will have special labelling derogation (for example, flammable pictogram is not needed).

 

As with candles, the Regulations need to be understood regarding the provision and content of the SDS and labelling and guidance needs to be followed.  If unsure, seek expert advice.

 

Cosmetics

Body oils for massage and direct application to the skin are considered to be cosmetics and will have their own special labelling requirements. As cosmetics, they will need to meet the requirements of the Cosmetics Regulation which from 2013 includes safety and efficacy requirements.  If any health claim is made, then this will need to be verified. 

 

If unsure about the Cosmetics Regulation (EC) No 1223/2009, it is important to seek expert advice.

 

If a finished cosmetic ready for use by the end user, there is no need for CLP labelling and no need for an SDS, even if classified as hazardous.  However, the retailers, distributors and importantly, professional users (eg masseurs) will need an SDS; this fact is disputed in some Member States, but the UK HSE demand that professional workers are protected through adequate communication.

 

Insect repellents

There is a grey area involving insect repellents.  If the product is marketed as a repellent, even with direct skin application, it is considered to be a biocidal product (Biocidal Product Regulation (EU) No 528/2012) and is Product Type 19.  However, if the same oil or fragrance is used primarily for other uses (eg in a candle with the smell being the function) or is used in cosmetics that make no direct repellency claim, then it does not need authorisation as a biocidal product.

 

The key is in the product claim and primary function and in view of the high costs for registration of biocidal products, the obvious choice for many suppliers will be to avoid making a direct claim as a repellent. However, REACH and CLP will ensure that if hazardous, the ingredients will still need to be identified and risk management put in place as needed.

 

There is scope in the Biocidal Products Regulation to exempt certain ‘natural’ and ‘non-hazardous’ products. 

 

Importing Candles and fragranced products

Even if considered ‘natural’, these products may require registration under REACH and CLP Notification.  There are special cases to consider and the boundary between ‘article’ and ‘chemical’ is a challenge to those trying to make legal definitions.

 

Chemicals needs to be registered if imported or manufactured over 1 tonne per annum and in the case of oils or candles, the base waxes and solvents need to be considered; the same waxes and solvents may be used across a range of products so total tonnage imported must consider the full product range. Some natural materials, such as bees wax or non-hazardous plant oils may be exempt from the registration process. Annex IV and V of REACH covers these.

 

REACH registration is not needed for ‘articles’; this includes the wick of the candle, the solid stick in diffusers or scented products (eg infused materials) and packaging.  However, for these ‘articles’ it is still necessary to check if imported products have Substances of Very High Concern (see below).

 

If the product is defined as an ‘article’, such as a scented product or specific shape that is primarily sold for its shape (a fragranced ornament or indeed, a candle without a wick that is there to look good but with no intent to set fire to), then registration of the fragrance may still be needed.  These are defined as articles with intended release of chemicals.

 

For REACH registration, the first step is to determine the chemical identity and to find the appropriate EC number.  So, for paraffin wax, this would be EC 232-315-6 and for limonene found in many citrus fragrances, EC 227-813-5 (R-Isomer). If it is a ‘natural’ chemical, then the vegetable source may suffice as chemical identity. If it is a completely new substance (for example an innovative substance) then it is necessary to have an EC number assigned through the CLP Notification (under 1 tonne) or through a REACH Inquiry (> 1 tonne).  CLP Notification is only required if hazardous.

 

The registration process can be complex and guidance on this needs to be accessed.  If already registered by others, then it is necessary to make contact with the Lead Registrant and negotiate access to the lead registration dossier.  This will inevitably involve paying for the access and the cost will depend on the amount of work done to make the lead registration and the number of registrants among whom the costs are divided.  The theory is that the costs to assess safety through (expensive) toxicity and environmental tests are shared by all those who plan to manufacture or import. 

 

CLP Notification is through REACH IT and is free.  This process only take a few minutes once fully understood.  It is not difficult, but can look scary to the first time users.  Mostly, if a chemical already on the system, it is possible to use links to the EU Chemical Inventory to link to the correct EC number.  However, if a new molecule, it is necessary to upload a chemical structure using a suitable picture file format.

 

Conclusions

Very simply, scented products need to be assessed for worker, consumer and environmental safety to allow supply.  If classified as hazardous, or if containing hazardous components above thresholds of concern, then correct labelling is needed and an SDS will need to be provided. Cosmetics and biocides are subject to their own rules and checks are needed in case products fall into these groups.

 

If importing or synthesising substances or extracting and purifying hazardous substances from plant products, REACH Registration and CLP Notification will need to be considered.

 

It is also important to be confident that any imported products do not contact SVHC

 

Further information

For further information on the source of guidance, help finding legal texts or if unsure if this applies to you in any way, please contact us.

Scented Candles and Aromatherapy

 

Introduction

REACH was set up to cover all aspects of the chemical supply industry and as part of this, provides definitions of chemical substances and articles; an article being an object where the physical properties and the shape define its function.  Candles are defined as chemical.

 

As with its predecessor, CLP defines hazardous substances and mixtures and sets out requirements for classification of hazards and the need to label chemical products accordingly. If hazardous, the REACH Regulation demands provision of a Safety Data Sheet (SDS)

 

The fragrances used in some scented candles and aromatherapy products, including reed diffusers, oils and other products containing essential oils and solvents are frequently classified as hazardous.  These hazards can include flammability of alcohol, aspiration hazard of oils and sensitisation of fragrances, especially terpenes. 

 

Contrary to the popular belief of many in this sector, ‘natural’ chemicals can be hazardous and CLP will apply to these.  REACH registration will apply if synthesising (extracting) or importing more than 1 tonne per annum; the ‘natural’ exemption applies if non-hazardous.  Registration is not considered further in this guide.

 

Therefore, if the chemical product is hazardous, it must be correctly labelled with identification of the hazardous components and a correctly formatted SDS is needed.