Introduction
For the last 5 years, we have seen the preeminence of healthy lifestyle everywhere in the world and essential oils have become the new must-have.
They can be used in various ways: on their own but also in cosmetics products or food. As a manufacturer, supplier or brand you have to comply with the regulation. On a case-by-case basis, you'll have to assess which regulation is the one you need to follow. This assessment needs to take into account relevant elements such as the presentation of the products, the ingredient, the mode of action and the claims.
What are essential oils?
The International Organization for Standardization (ISO) in their Vocabulary of Natural Materials ISO 9:235:2013 defines an essential oil as “a product made by distillation with either water or steam or by mechanical processing of citrus rinds or by dry distillation of natural materials. Following the distillation, the essential oil is physically separated from the water phase.”
Essential oils can be produced from various plants or flowers and contain over 100 chemical compounds.
Essential oils used as Raw Materials in Finished Products
Please see below the various regulatory frameworks you might be facing.
REACH: Registration, Evaluation, Authorization and Restriction of Chemicals
The production and placing on the market of essential oils is bound by the chemical substances legislation. Therefore, they may need to be registered under the REACH regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals).
The REACH registration process requires EU manufacturers and importers of chemicals to submit a registration dossier to ECHA when they place more than 1 metric tonne per year of a chemical on the EU market. The REACH dossier includes information on substances such as physical and chemical properties, effects on human health, effects on the environment and the evaluations which prove the above statement.
If you’re located outside the EU you’ll need to designate an Only Representative, called OR.
CLP: Classification, labeling, and packaging of chemicals
The “CLP” acronym stands for Classification, Labeling and Packaging”. This regulation (EC No 1272/2008) came into force in January 2009 and builds on the Globally Harmonized System” (GHS). It requires placing symbols and phrases warning users and giving safety advice on the label of chemical substances packaging.
Labeling
If you intend to place your essential oils on the European Market your labels must include the following:
- Product name/INCI name
- Batch code
- Place of origin
- Name and address of exporter
- Date of manufacture
- Best before date
- Net weight
- Recommended storage conditions
- Organic products: certification number
Various essential oils are classified as hazardous (for example, tea tree oil); you should always include the relevant safety and risk phrases but also hazard symbols.
Packaging
To ensure an optimal preservation of essential oils, you must use containers made of material that does not react with the oil’s components and ensure that the packaging can be reused and/or recycled. Always use clean and dry containers before filling them with your essential oils and fill the headspace with a gas compatible with the oils components. You should respect the storage advice that is on the label (usually a dry and cool place to avoid any deterioration).
Note: Organic essential oils must be physically separated from conventional essential oils.
CITES: Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)
CITES is an international regulation, which aims to protect endangered species. Wild animals and plants products can be targeted by this Convention. Make sure you're not concerned by the CITES regulation. If your products fall under this regulation according to Annex A / B of Regulation EC 338/97 you must obtain exportation permits beforehand.
SDS: Safety Data Sheets
If you’re manufacturing or selling your essential oils throughout the EU market and they’re classified under CLP, then you must ensure that a safety data sheet has been created and is up to date for each product. This obligation is set by the article 31 of REACH regulation “a safety data sheet shall be provided free of charge on paper or electronically at the latest on the date on which the substance or mixture is supplied for the first time.”
The Safety Data Sheet provides:
- Details of the health risks associated with exposure or use of dangerous products
- All the information on the handling
- The document must be provided in the language of the country where the product will be used.
Additional requirements
Additional requirements can be asked by your buyer. The following list is non-exhaustive and given only for your information:
- Technical Data Sheet (TDS) or Specification, including CAS number. For new oils, exporters will need to apply for a CAS number
- Certificates of analysis, to support the claims of the specification, see the above examples
- GMO certificate (if requested)
- Certificate of origin
- Product information sheet
- Allergen declaration
- Good Manufacturing Practices (GMP) certificate
- Good Agricultural and Collection Practices (GACP) certificates
- Certification as organic or fair production certificate
- IFRA certificate
Essentials oils as Finished products
The claims you associate to your finished product determine the regulatory framework that applies to your product. See below a summary of the main requirements for each regulation.
• No specific claim: CLP & REACH Regulations
If you’re placing essential oils as finished products on the EU market and you do not associate any specific claim to them, then your products only need to comply with the REACH and CLP regulations. You can refer to the section “Essential oils as Raw Materials”.
• Cosmetic Regulation EC No 1223/2009
The EU Cosmetic Regulation must be followed if your essential oil is marketed as a cosmetic product. You’ll need to comply with the cosmetic regulation from the formulation to the label and packaging.
E.G.: Citrus oil bath perfumer that leaves your skin perfumed
To be fully compliant follow the 5 steps below:
- Designate a Responsible Person
- Check the compliance of your formulas
- Collect necessary data and draft the Product Information File (PIF)
- Update your labels to a compliant format
- Ensure CPNP notification before placing products on the market
• Biocides Regulation EC N° 528/2012
The biocides regulation will apply if your product contains “any substance or mixture, in the form in which it is supplied to the user, consisting of containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action”
Also, the claims made on the products will affect the categorization of your products: E.G. Citrus oil as mosquito repellent will be a biocide.
You must label your product in accordance with the biocides requirements:
- Identify of Active substance and its concentration
- Nanomaterials [nano]
- Authorization number of biocides products
- Name and address of the authorization holder
- Type of formulation
- Uses authorized
- Directions for use, frequency of application and dose rate
- Adverse side effects and any directions for first aid
- The sentence: Read attached instructions before use
- Direction for safe disposal of the biocidal product and its packaging
- Batch number and expiry date
- Period of time needed for biocidal effect, precautionary measures, etc.
- Categories of users
- Information on any danger to environment/non-target organisms/water
- Micro-organisms, labeling in accordance with Directive 2000/54/EC (protection of worker)
All information must appear clearly on the label in indelible, legible and visible lettering.
If you advertise your product, you must write the following sentence: “use biocides safely. Always read the label and product information before use” (you can replace the word biocide with the product-type being advertised).
• Detergent Regulation EC No 648/2004
According to the definition provided by the EU regulation, a “detergent” means any “substance or mixture containing soaps and/or other surfactants intended for washing and cleaning processes. Detergents may be in any form (liquid, powder, paste, bar, cake, molded, piece, shape, etc.) and marketed for or used in household, or institutional or industrial purposes”.
E.G.: Citrus oil as window cleaner
You must follow the detergent regulation to properly label your essential oil if you’re claiming so. The label must contain:
- The name and trade name of the product
- The name or trade name or trademark and full address and telephone number of the party responsible for placing the product on the market
- The address, email, where available, and telephone number from which the referred datasheet can be obtained
- This information must appear in legible, visible and indelible characters on the packaging for consumers. The packaging must indicate the content, in accordance with the specifications provided in Annex VII A for general public. It shall also indicate instructions for use and special precautions if required.
The label of a detergent product must also comply with the Classification, Labeling, and Packaging (CLP) Regulation.
Introduction
For the last 5 years, we have seen the preeminence of healthy lifestyle everywhere in the world and essential oils have become the new must-have.
They can be used in various ways: on their own but also in cosmetics products or food. As a manufacturer, supplier or brand you have to comply with the regulation. On a case-by-case basis, you'll have to assess which regulation is the one you need to follow. This assessment needs to take into account relevant elements such as the presentation of the products, the ingredient, the mode of action and the claims.
What are essential oils?
The International Organization for Standardization (ISO) in their Vocabulary of Natural Materials ISO 9:235:2013 defines an essential oil as “a product made by distillation with either water or steam or by mechanical processing of citrus rinds or by dry distillation of natural materials. Following the distillation, the essential oil is physically separated from the water phase.”
Essential oils can be produced from various plants or flowers and contain over 100 chemical compounds.
Essential oils used as Raw Materials in Finished Products
Please see below the various regulatory frameworks you might be facing.
REACH: Registration, Evaluation, Authorization and Restriction of Chemicals
The production and placing on the market of essential oils is bound by the chemical substances legislation. Therefore, they may need to be registered under the REACH regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals).
The REACH registration process requires EU manufacturers and importers of chemicals to submit a registration dossier to ECHA when they place more than 1 metric tonne per year of a chemical on the EU market. The REACH dossier includes information on substances such as physical and chemical properties, effects on human health, effects on the environment and the evaluations which prove the above statement.
If you’re located outside the EU you’ll need to designate an Only Representative, called OR.
CLP: Classification, labeling, and packaging of chemicals
The “CLP” acronym stands for Classification, Labeling and Packaging”. This regulation (EC No 1272/2008) came into force in January 2009 and builds on the Globally Harmonized System” (GHS). It requires placing symbols and phrases warning users and giving safety advice on the label of chemical substances packaging.
Labeling
If you intend to place your essential oils on the European Market your labels must include the following:
- Product name/INCI name
- Batch code
- Place of origin
- Name and address of exporter
- Date of manufacture
- Best before date
- Net weight
- Recommended storage conditions
- Organic products: certification number
Various essential oils are classified as hazardous (for example, tea tree oil); you should always include the relevant safety and risk phrases but also hazard symbols.
Packaging
To ensure an optimal preservation of essential oils, you must use containers made of material that does not react with the oil’s components and ensure that the packaging can be reused and/or recycled. Always use clean and dry containers before filling them with your essential oils and fill the headspace with a gas compatible with the oils components. You should respect the storage advice that is on the label (usually a dry and cool place to avoid any deterioration).
Note: Organic essential oils must be physically separated from conventional essential oils.
CITES: Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)
CITES is an international regulation, which aims to protect endangered species. Wild animals and plants products can be targeted by this Convention. Make sure you're not concerned by the CITES regulation. If your products fall under this regulation according to Annex A / B of Regulation EC 338/97 you must obtain exportation permits beforehand.
SDS: Safety Data Sheets
If you’re manufacturing or selling your essential oils throughout the EU market and they’re classified under CLP, then you must ensure that a safety data sheet has been created and is up to date for each product. This obligation is set by the article 31 of REACH regulation “a safety data sheet shall be provided free of charge on paper or electronically at the latest on the date on which the substance or mixture is supplied for the first time.”
The Safety Data Sheet provides:
- Details of the health risks associated with exposure or use of dangerous products
- All the information on the handling
- The document must be provided in the language of the country where the product will be used.
Additional requirements
Additional requirements can be asked by your buyer. The following list is non-exhaustive and given only for your information:
- Technical Data Sheet (TDS) or Specification, including CAS number. For new oils, exporters will need to apply for a CAS number
- Certificates of analysis, to support the claims of the specification, see the above examples
- GMO certificate (if requested)
- Certificate of origin
- Product information sheet
- Allergen declaration
- Good Manufacturing Practices (GMP) certificate
- Good Agricultural and Collection Practices (GACP) certificates
- Certification as organic or fair production certificate
- IFRA certificate
Essentials oils as Finished products
The claims you associate to your finished product determine the regulatory framework that applies to your product. See below a summary of the main requirements for each regulation.
• No specific claim: CLP & REACH Regulations
If you’re placing essential oils as finished products on the EU market and you do not associate any specific claim to them, then your products only need to comply with the REACH and CLP regulations. You can refer to the section “Essential oils as Raw Materials”.
• Cosmetic Regulation EC No 1223/2009
The EU Cosmetic Regulation must be followed if your essential oil is marketed as a cosmetic product. You’ll need to comply with the cosmetic regulation from the formulation to the label and packaging.
E.G.: Citrus oil bath perfumer that leaves your skin perfumed
To be fully compliant follow the 5 steps below:
- Designate a Responsible Person
- Check the compliance of your formulas
- Collect necessary data and draft the Product Information File (PIF)
- Update your labels to a compliant format
- Ensure CPNP notification before placing products on the market
• Biocides Regulation EC N° 528/2012
The biocides regulation will apply if your product contains “any substance or mixture, in the form in which it is supplied to the user, consisting of containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action”
Also, the claims made on the products will affect the categorization of your products: E.G. Citrus oil as mosquito repellent will be a biocide.
You must label your product in accordance with the biocides requirements:
- Identify of Active substance and its concentration
- Nanomaterials [nano]
- Authorization number of biocides products
- Name and address of the authorization holder
- Type of formulation
- Uses authorized
- Directions for use, frequency of application and dose rate
- Adverse side effects and any directions for first aid
- The sentence: Read attached instructions before use
- Direction for safe disposal of the biocidal product and its packaging
- Batch number and expiry date
- Period of time needed for biocidal effect, precautionary measures, etc.
- Categories of users
- Information on any danger to environment/non-target organisms/water
- Micro-organisms, labeling in accordance with Directive 2000/54/EC (protection of worker)
All information must appear clearly on the label in indelible, legible and visible lettering.
If you advertise your product, you must write the following sentence: “use biocides safely. Always read the label and product information before use” (you can replace the word biocide with the product-type being advertised).
• Detergent Regulation EC No 648/2004
According to the definition provided by the EU regulation, a “detergent” means any “substance or mixture containing soaps and/or other surfactants intended for washing and cleaning processes. Detergents may be in any form (liquid, powder, paste, bar, cake, molded, piece, shape, etc.) and marketed for or used in household, or institutional or industrial purposes”.
E.G.: Citrus oil as window cleaner
You must follow the detergent regulation to properly label your essential oil if you’re claiming so. The label must contain:
- The name and trade name of the product
- The name or trade name or trademark and full address and telephone number of the party responsible for placing the product on the market
- The address, email, where available, and telephone number from which the referred datasheet can be obtained
- This information must appear in legible, visible and indelible characters on the packaging for consumers. The packaging must indicate the content, in accordance with the specifications provided in Annex VII A for general public. It shall also indicate instructions for use and special precautions if required.
The label of a detergent product must also comply with the Classification, Labeling, and Packaging (CLP) Regulation.
