Ekotox EU

Do you manufacture or import candles? Know your responsibilities

Manufacturers and importers of candles (including scented waxes) operating in the European Union market are required to comply with specific legal obligations aimed at protecting user health and the environment. These regulations not only ensure consumer safety but also promote responsible production and transparency throughout the supply chain. Compliance with these regulations helps build brand trust and minimizes risks associated with trading chemical products in the demanding EU market.

According to Regulation 1907/2006 (REACH) and Regulation 1272/2008 (CLP), candles are classified as chemical mixtures. As a result, they must meet specific requirements regarding classification and labeling. If a candle is classified as hazardous, its supplier has additional responsibilities before introducing it to the market and the product itself must be appropriately labeled and packaged. The responsibility for classifying a substance or mixture primarily lies with the importer or manufacturer, while the obligation to ensure that labeling complies with CLP regulations falls on every supplier in the supply chain.

The classification of a candle depends on the ingredients it contains and their concentrations. Information on the classification of each ingredient should be obtained from raw material suppliers (in the case of own candle production) or from the supplier of the finished product (in cases of distribution or import). Relevant information should be included in section 3 of the Safety Data Sheet (SDS) provided by the supplier.

Candles mainly consist of waxes, which are typically unclassified. However, they often contain fragrance and coloring additives that may be classified as hazardous. Commonly, these include skin sensitizers, such as limonene or cinnamaldehyde. In some cases, ingredients that pose other health risks, like skin irritation, may be present, and in rare instances, more serious hazards. In certain situations, environmental classification may also be required.

Safety Data Sheet

A Safety Data Sheet (SDS) is essential for candles classified as hazardous. The SDS contains detailed information about hazards and safe usage of the product and must be prepared in accordance with Commission Regulation (EU) 2020/878 in the official language(s) of the country where the mixture is marketed. If candles are sold directly to consumers, an SDS is not required; however, the candle label must include all required information as per CLP regulations.

If you do not supply products directly to end-users, for example: if you provide candles for resale, you must supply the SDS to the distributor or retailer. An SDS is also required if the product is intended for professional use, such as in restaurants.

In some cases, an SDS for an unclassified candle must be made available upon request from the recipient. This applies when the mixture contains:

Safety label

A hazardous mixture must be packaged and labeled according to CLP regulations. A CLP label cannot be applied directly to the wax of the candle, as it is considered a mixture, not packaging. Furthermore, an open glass container, an aluminum tealight base or an openwork paper box is not deemed suitable packaging for hazardous mixtures under CLP. A candle in such a container must be provided in packaging that meets CLP requirements. The label must be permanently affixed to the surface of the packaging that directly contains the candle and positioned on the side to allow easy horizontal reading of the text.

A CLP-compliant safety label must include several essential elements:

The CLP regulation also specifies, among other things, the minimum size of the label and pictograms, the arrangement of label elements, and rules for using fold-out labels. The forthcoming version of CLP, which has yet to be officially published, will also regulate the minimum font size.

Notification to the Classification and Labelling Inventory

If you are importing a candle, a perfume blend or any other mixture or a substance for candle production, you may be required to submit a notification to the Classification and Labelling Inventory. Hazardous substances, whether imported as pure substances or in mixtures, must be reported to this registry regardless of the tonnage.

Poison Center Notification (PCN) and Unique Formula Identifier (UFI)

If a candle is classified as hazardous to human health or due to its physical properties, it must be reported to Poison Centers (known as Poison Center Notification – PCN) in the countries where it will be marketed. A key part of the PCN submission is the UFI code, which must also appear on the product label. The UFI (Unique Formula Identifier) is a unique 16-character alphanumeric code assigned to a specific formulation, allowing Poison Centers to quickly access product composition information, which is crucial in emergencies.

REACH Registration

Any substance manufactured or imported in quantities exceeding 1 ton per year is subject to registration under REACH. This applies to both pure substances and substances within mixtures. For imports, the quantities of imported substances (primarily paraffin in the case of candles) should be closely monitored, and REACH registration must be completed upon exceeding 1 ton per year. When sourcing raw materials from EU suppliers, compliance with REACH should be ensured by the respective contractors.

SCIP Database Notification

Candles are considered a combination of a mixture and an article. If an article contains substances of very high concern (SVHC) in concentrations above 0.1%, it must be reported to the SCIP database. For instance, boric acid in the candle wick may require such notification. The SCIP database was established under the EU Waste Framework Directive to identify products with potential environmental and health impacts. It includes a product category covering “Candles and similar articles.”

Safety Standards for Candles

In addition to compliance with REACH and CLP regulations, candles must meet certain quality standards, including:

Adhering to these standards is essential for product safety and market compliance. Extra labeling requirements, separate from CLP labeling, may also apply.

Compliance with EUDR

Regulation (EU) 2023/1115 on deforestation-free products (EUDR), we have previously discussed on our website, may also apply to candles. If materials like palm oil, palmitic acid, stearic acid or glycerin are used in candle production, European manufacturers will likely be subject to this regulation. Key obligations include:

Companies must implement due diligence processes to demonstrate that their products are not linked to deforestation.

Challenges and support in meeting legal requirements

Legal requirements for candle production and import can seem complex, but compliance is essential for protecting user health and the environment. For professional assistance, please feel free to contact us.

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