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.
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
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
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
Regarding the details of labelling, it is
essential to understand the CLP Regulation or get expert advice.
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
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.
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
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.
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
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
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.
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.
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
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
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.
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
It is also
important to be confident that any imported products do not contact SVHC
information on the source of guidance, help finding legal texts or if unsure if
this applies to you in any way, please contact us.
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
Therefore, if the
chemical product is hazardous, it must be correctly labelled with
identification of the hazardous components and a correctly formatted SDS is