Skip to Content Skip to Navigation

What requirements must natural ingredients for cosmetics comply with to be allowed on the European market?

Takes about 27 minutes to read

If you want to get your natural ingredients for cosmetics on the European market, you will have to source in a sustainable way. You also need to comply with international conventions on supply and trade in plants. Buyers expect detailed documentation on your company, process and product. This procedure is intended to ensure compliance with legislation on cosmetic products and their ingredients. Company-level certification in terms of quality assurance is increasingly important. Buyers can also have additional requirements for Corporate Social Responsibility (CSR).


1 . Which requirements must you comply with to export cosmetic ingredients to Europe?

You can only get your product on the European market if you:

  • comply with the European Union Cosmetics Regulation (Regulation (EC) 1223/2009);
  • provide the right documentation;
  • comply with legislation on Registration, Evaluation and Authorisation of Chemicals (REACH);
  • comply with rules for Classification, Labelling and Packaging (CLP);
  • follow rules for claim substantiation;
  • are able to demonstrate your ability to deliver sufficient quantities, on time, and at the right quality and price.

Below, you can find information on each of these requirements.

Check our Workbook on preparing a technical dossier for cosmetic ingredients for additional information.

Please note that this series of CBI market reports uses the definition of “natural” from the REACH regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals). This definition includes the one in Article 3(39), in conjunction with substances listed in Annex IV and substances that fall under the definitions of Annex V, especially but not exclusively Paragraphs 8 and 9.

Definitions of natural and synthetic

REACH defines natural as a naturally occurring substance as such, unprocessed or processed only by:

  • manual, mechanical or gravitational means;
  • dissolution in water;
  • flotation;
  • extraction with water;
  • steam distillation or heating solely to remove water;

or which is extracted from air by any means.

A synthetic ingredient is a substance that does not occur in nature. An ingredient, such as a botanical extract, can be a mixture of substances that occur in nature and substances that do not occur in nature.

Cosmetics Regulation (EC 1223/2009)

The Cosmetics Regulation covers the safety and efficacy of cosmetic products, including claims. Although it applies to finished cosmetic products, there are several implications for you as an ingredient supplier:

  • Check the lists of prohibited and restricted substances, allowed colourants, preservatives and UV filters to see whether your cosmetic ingredients can be used in cosmetics.
  • You need to give your buyers detailed product information. Buyers need to include this in a “Cosmetic Product Safety Report” and a “Product Information File”. You need to provide information on the physio-chemical (physical and chemical), microbiological and toxicological characteristics of your ingredients.
  • Since product safety and transparency on safety are essential in Europe, requirements on allergens are becoming stricter. Legislation covers an increasing number of allergens and additional labelling requirements (such as listing all allergens on cosmetic lists of ingredients). Allergen legislation might become stricter in future. The Scientific Committee on Consumer Safety (SCCS) has determined that the current regulations on fragrance allergens are insufficient. The SCCS identified more than 100 additional individual substances and natural extracts as likely contact allergens.
  • Data on efficacy (performance) increases the value of your raw material. Manufacturers are very interested in data that substantiate claims for certain cosmetic benefits resulting from a known concentration of the ingredient (or component of an ingredient) in a finished product. However, please note that not all customers want to buy ingredients with cosmetic claims.

Tips:

  • Consult the Trade Helpdesk for a full list of requirements. Select your specific product code under Chapter 12, 13, 15 or 33.
  • Ask your buyers which information they require and in which format they want it. Cosmetic manufacturers and ingredient producers may make you responsible for the information that they need in safety reports and information files. If you can provide all information needed, you can offer your buyer a better package. European buyers communicate their requirements in different ways. Some buyers have extensive “supplier manuals” which describe all requirements in detail, while others provide very little information.
  • Do not test your new ingredients on animals. Find alternative methods. Even though there are some exceptions to the marketing ban in the European Union, buyers usually want to avoid animal testing altogether.
  • Use the Raw Material Information Form published by the Personal Care Products Council as guidance on the requirements.
  • Use the Plan of the Toxicological Assessment file template published by UNITIS as a reference for the information that you need to give to your buyers.
  • Read more about marketing conditions for cosmetic products in the Trade Helpdesk.
  • If you produce botanical extracts, use suitable solvents and only use approved preservatives or no preservatives at all. If your ingredients are used in socalled preservative-free cosmetics, you need to gain expertise in microbiology, because these cosmetics have their own quality liabilities.
  • See our Workbook for preparing a technical dossier for cosmetic ingredients for additional information and tips.
  • Keep up to date with upcoming changes within European Union cosmetics legislation in terms of the labelling of natural and organic products. See the section on Natural cosmetics below.
  • Contact Open Trade Gate Sweden if you have specific questions regarding rules and requirements in Sweden and the European Union.

Documentation

To comply with legal requirements, buyers need well-structured product and company documentation. Buyers make increasing demands in terms of traceability, sustainability and quality, which all need to be documented. This documentation acts as an insurance to buyers. You need to supply detailed:

  • Technical Data Sheets (TDS);
  • Certificates of Analysis;
  • Safety Data Sheets (SDS).

These data sheets are becoming increasingly large and complicated because of all the information that they need to comply with legislative requirements. European standards for SDS are likely also used in other regions. See the section on Classification, Labelling and Packaging below for more information on SDS requirements.

European buyers also need you to fill out supplier questionnaires. Buyers use these questionnaires to audit their suppliers. The questionnaires also provide a documented record of statements made by suppliers on a wide range of topics about the company, its products and its standards. As compliance with legal requirements becomes more complicated, these questionnaires are becoming longer. Topics cover:

  • the type and origin of ingredients;
  • the way that ingredients are produced;
  • labour and environmental policies and practices (see also Social and environmental responsibility below).

If you supply essential oils, you also need to compose an allergen declaration in accordance with the European Union Cosmetics Regulation and the standards of the International Fragrance Association (IFRA). If you supply vegetable oils, you need to pay attention to the protein content (which can cause allergic reactions) as well as to other undesirable components that may be present. See our Workbook for preparing a technical dossier for more information and examples of such a declaration.

Tips:

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

REACH refers to the European chemicals legislation aimed primarily at European manufacturers and importers. It is designed to manage the risks of chemicals manufactured and used in the European Union.

Cosmetic ingredients (including natural ingredients) are chemical substances or chemical mixtures and, unless exempted, need to be registered with European authorities by the importer or manufacturer of the ingredient. To register new substances, their hazards need to be evaluated before they are authorised for use on the European market.

If your cosmetic ingredient (substance) is not registered, it cannot be sold in the European Union. However, not all cosmetic ingredients need to be registered. European producers or importers of cosmetic ingredients need to prove that their ingredient meets the exemption criteria. Ingredients that do not need to be registered are:

  • naturally occurring and chemically unmodified substances, such as vegetable oils;
  • ingredients that are imported in quantities of less than 1 tonne annually per importer.

Since 31 May 2018, all products in the EU above 1 tonne need to be registered.

You can register new cosmetic ingredients yourself by setting up your company as an “Only Representative” of your company in Europe. This procedure gives you more protection as a supplier, because you do not depend on one importer who holds the registration. However, registration will cost over ten thousand euros. It can even reach up to several hundreds of thousands of euros, depending on the safety and environmental profile as well as the import volumes.

Common ingredients are probably already registered under REACH by an importer or manufacturer or by a consortium of companies. The registration of new ingredients is the responsibility of a European company or “Only Representative”. It is a costly process, where your business partner might also require you to supply safety data. Joining a consortium reduces costs. By establishing a European entity to act on your behalf, you can also “buy into” those consortia and join their registration, but you will need to contribute to the costs. The European Chemicals Agency (ECHA) can help you with this process. You can contact the ECHA to find consortia for your product. By signing a letter of access and paying a contribution, you can join the consortium.

How to deal with REACH:

  • If your ingredient is registered under REACH, ask the European Federation of Essential Oils (EFEO) which company is allowed to import the ingredient. These are potential buyers for your ingredient. Alternatively, determine whether it is worth to join the registration through consortia that have completed the registration.
  • If your ingredient is not registered under REACH, find out whether it needs to be.
  • Is your product exempted from registration? Have a look at Annex IV of the REACH regulation and the guidance for exemptions (Annex V), published by the European Chemicals Agency.
  • If it does need to be registered, decide whether registering the ingredient yourself is worth the investment. What volumes could you supply, what is the value of your ingredient? Are they sufficient to pay for your high investments? Discuss with your potential European business partner whether they are willing to form an alliance to go through the registration process with you. Be aware that your partner is likely to ask exclusivity to be the first to market.

Tips:

Classification, Labelling and Packaging (CLP)

Cosmetic ingredients are chemicals. Because of this fact, you need to label and package them in a way that shows their potential dangers to workers who use them in the supply chain. This procedure is regardless of REACH legislation and the volumes exported to Europe per year. Specific requirements which apply depend on the classification of the ingredients that you export.

The European Union has set packaging and labelling requirements of chemicals based on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS). You can use these requirements to find out how your ingredient is classified and which pictograms and other notices you need to include on its label.

You also need to include information on potentially dangerous characteristics of chemical substances on your Safety Data Sheet (SDS). This information needs to match the requirements of REACH regulation; see our Workbook for preparing a technical dossier for cosmetic ingredients for more information. The SDS gives workers and emergency personnel information on procedures to handle or work with that chemical safely. Here, you also need to include information on:

  • physical data (melting point, boiling point, flash point, and so on);
  • toxicity;
  • health effects;
  • first aid;
  • reactivity;
  • storage;
  • disposal;
  • protective equipment;
  • spill handling procedures.

You need to have in-house competences in order to prepare the necessary SDS for your ingredients. If you do not have this competence, you must use the services of properly qualified parties to help you prepare the SDS.

Tips:

  • Look at the websites of natural ingredients companies for examples of an SDS, such as The Soap Kitchen.
  • You can also seek qualified advice in preparing an SDS from specialised service providers.
  • Check the website of the European Chemicals Agency, which includes a classification and labelling database. In this database, you can search for a substance and find out the symbols and warning phrases that you need to add to your labelling. You can look for substances by their name and by the European Inventory of Existing Commercial Chemical Substances (EINECS) or Chemical Abstract Service (CAS) numbers.
  • On the SpecialChem INCI Directory, you can find information on cosmetic ingredients by using either the relevant INCI name (International Nomenclature of Cosmetic Ingredients) or the CAS Number.
  • Read more about Classification, Labelling and Packaging (CLP) on the Trade Helpdesk website.
  • See our Workbook for preparing a technical dossier for cosmetic ingredients for additional information and tips.

Claim substantiation (Regulation 655/2013)

You can only make claims for cosmetic products if you can substantiate these claims. The Cosmetics Regulation sets criteria for this proof, with which you need to comply. Cosmetic manufacturers are increasingly looking for ingredients with a proven efficacy. This leads to a stronger focus on efficacy, especially for active extracts.

This can be a threat for you, as you will need to provide additional documentation to new buyers to prove the efficacy of new ingredients. Validated product claims give cosmetic manufacturers the chance to bring innovative products to the market with a clear marketing story. It provides consumers with more security, which should support the product sales and drive demand for the ingredients used in the claim. However, there are significant costs to preparing a dossier on efficacy claims. Furthermore, specific efficacy claims for an ingredient may not translate easily into claims for different finished products. To this end, carefully weigh up the pros and cons of obtaining efficacy data.

Tips:

  • Study the criteria for the justification of claims for cosmetics. These will have important implications for what evidence you need to support your claim.
  • Analyse labelling and wording possibilities to ensure that you “sell an appropriate claim”. Look for product examples already sold in Europe through online retailers.
  • Provide in vitro data (from cell research in a laboratory) on the efficacy of your product to raise interest in Europe. With these data, processors or manufacturers can more easily include your ingredient in a product development process. They can also use your data as an intermediary to approach manufacturers themselves.
  • Go beyond documentation on traditional use to justify the claim that you make. Although this factor has a strong marketing value and adds backing to the dossier, it is not sufficient by itself to justify a cosmetic claim.

CITES (Convention on International Trade in Endangered Species of wild fauna and flora)

You need to comply with requirements on trading plant resources as agreed internationally under CITES. The European Union has translated this convention into European law. Most likely, your own country is also a signatory, meaning that you also need to comply with it to meet national law. CITES aims to protect endangered plants and plant products by regulating their trade. It provides a list of plant species that you cannot export/import or where export/import is restricted. If your product is listed in Annex A and Annex B of Regulation (EC) No 338/97, you need to get an export permit from your country’s CITES authority. You will also need an import permit from the country to which you are exporting.

Tips:

Convention on Biological Diversity (CBD)/Access and Benefit-Sharing (ABS)

International treaties and protocols on using plant resources within the scope of the Convention on Biological Diversity are part of European Union law, but most likely also of your national law. This situation means that you will also need to comply with them to meet national law.

The goal of the Nagoya Protocol of the Convention on Biological Diversity (CBD) is to make sure that the benefits of genetic resources and traditional knowledge are shared in a fair way. This is called Access and Benefit-Sharing (ABS).

ABS is especially important for wild-collected ingredients.

The Nagoya Protocol provides guidelines for accessing and utilising genetic resources and traditional knowledge as well as the fair and equitable sharing of the benefits. Many countries have signed this protocol and have adopted it into national law. If your home country has done so as well, you need to comply with these national laws. European companies are legally required to ensure that the ABS legislation has been complied with in the country of origin and followed downstream to their business.

Tips:

  • Find out the status of Access and Benefit-Sharing legislation in your country, as well as whether sourcing and processing your ingredients falls within the scope of that legislation.
  • Find out how your country defines the “utilisation” of resources, which determines whether legislation applies. Does the definition include all uses of plant materials or only the use of genetic resources for research and development (R&D)?
  • Develop a procedure to check whether ABS applies to every new genetic resource or traditional knowledge that you want to develop. This includes knowing the local context and officials. Have a look at the CBD website for more information, which also includes country profiles.
  • Demonstrate that you comply with CBD principles and offer security to partners/buyers. Contact local officials for more information.
  • Show that you are well connected to national focal points of the CBD in order to win the trust of buyers and to make you a more attractive business partner.

2 . Which additional requirements do buyers often have?

Many buyers have additional requirements for natural ingredients for cosmetics. You need at least a basic level of compliance to find a buyer in Europe, but some suppliers may demand that you meet many more of these requirements.

Regardless of the type of ingredient that you supply, European buyers demand sustainable sourcing in terms of quantity and quality, as well as compliance with basic CSR principles.

Quality management

European buyers expect you to have good and reliable quality standards in raw material production and manufacturing:

  • If you cultivate or collect raw materials, you should follow Good Agricultural and Collection Practices (GACP) before processing.
  • At the least, buyers expect you to follow Hazard Analysis & Critical Control Points (HACCP) principles in your processing facilities. Using these principles prevents hazards to food safety but also helps ensure product safety for cosmetic applications. While HACCP certification is not obligatory, it will give you a competitive advantage. If your product is also used in the European food industry, you will already need to have HACCP certification as a minimum standard. Your own country may have more stringent requirements independent of European requirements.
  • If you want to do more, you can use the Good Manufacturing Practices (GMP) developed by the European Federation for Cosmetic Ingredients.
  • Certifying your quality management system according to ISO 9001:2015 assures buyers that you can manage all relevant quality management processes in your company.
  • Food sector certification such as ISO 22000, BRC or similar build additional trust that you can manage product safety.
  • If buyers refer to product quality standards in their product specifications, they expect you to comply with them. Examples include standards from the International Organization for Standardization (ISO) or the International Fragrance Association (IFRA, for essential oils).

Tips:

  • Monitor the quality of raw materials before they arrive at your processing facility. This is crucial to ensure consistent quality.
  • Implement a good management system. At least follow HACCP principles. If you use the Good Manufacturing Practices (GMP) of the European Federation for Cosmetic Ingredients, you can create a competitive advantage.
  • Make sure that you and your suppliers comply with the GACP guidelines of the World Health Organization in all your operations and activities. Also show that you follow GACP guidelines in your marketing materials. This can give you an edge over your competitors.
  • Prepare analysis reports with information on the quality of your product. Depending on the ingredient, European buyers may ask for this information.

Sustainable sourcing

Most buyers will only do business with sustainable suppliers. Consumers want to know more about the sustainability and traceability of the products which they buy, while buyers want to ensure that they are “safe” in terms of compliance with sustainability expectations of consumers. To answer these questions, your buyers may demand that you provide additional proof of sustainable sourcing.

Buyers indicate that sustainability is a key trend which will only become more important in future. In the long term, buyers may no longer want to work with suppliers that fail to improve the sustainability of their company and ingredients.

You do not need to certify your sustainable practices. However, certification can help you to enter niche markets and support the credibility of your sustainability claims. Read more about relevant sustainability standards in the section on niche markets below. Additionally, buyers want you to be transparent in the sustainability of your products and support this transparency with data on local impact.

If you collect plants from the wild, your sourcing practices need to avoid overharvesting to ensure the future availability of your products. You also need to provide living wages to your collectors.

European buyers increasingly demand their suppliers to follow sustainable collection practices, because they are facing supply shortages for a growing number of plant species. The main reasons for these shortages are overharvesting, habitat destruction and fewer collectors.

Tips:

  • Conduct a resource assessment and implement a resource management system; for example, as prescribed by FairWild certification. Detailed information on availability is crucial for buyers.
  • If you supply cultivated ingredients, demonstrate sustainability by producing according to organic principles.
  • If you supply wild-collected ingredients, check the status of regulations in your own country regarding the Convention on Biological Diversity.
  • Check the conservation status of your species to determine their availability and sustainability threats. For example, see the red list of the International Union for Conservation of Nature (IUCN).
  • Show that you practise sustainable wild collection. Show how your company impacts biodiversity and provide documentation of sustainable collection practices.
  • Show sustainable wild collection by implementing Good Agricultural and Collection Practices (GACP) through FairWild certification, collecting according to BioTrade Principles and Criteria or documenting sustainable collection practices.
  • Determine your options to domesticate species that are insufficiently available in Europe. Always determine the economic viability of such trajectories first with a feasibility study.

Social and environmental responsibility – Corporate Social Responsibility (CSR)

European buyers are looking for suppliers who comply with good standards of social and environmental responsibility. Although buyers are looking for CSR compliance, not all of them have set requirements for CSR. In general, they select suppliers who have a code of conduct and who aim to improve their performance in key areas, such as child labour and limiting damage to the environment.

You can demonstrate CSR policies by:

  • following company-specific policies (for example, of large manufacturers);
  • implementing international initiatives from the industry (for example, the Business Social Compliance Initiative);
  • developing your own code of conduct.

Industry sources claim that social responsibility systems will become a basic market entry requirement in the near future. You need to show potential buyers that you know how you score on CSR and that you set targets to improve it.

Tips:

  • At the very least, build awareness of CSR in your company and comply with the basic principles (such as no child labour).
  • If you want to do more, develop a code of conduct for your company as well as your suppliers that covers social and environmental performance.
  • Have a look at social responsibility platforms such as the Supplier Ethical Data Exchange (SEDEX). These platforms provide a template of the typical information required. They also facilitate the sharing of this information with potential customers.
  • Assess your CSR performance; for example, by doing a self-assessment. Check your performance against publically available standards such as FairWild or SA 8000. You can also consider certifying according to such standards.
  • Read more about the United Nations Global Compact. Some buyers demand compliance with the ten principles of this initiative. These cover human rights, labour standards, the environment and anti-corruption.

3 . What are the requirements for niche markets?

If you want to sell your ingredients to manufacturers of natural or organic cosmetics, your production needs to follow the guidelines for natural and organic standards. You can also certify your ingredients as Fairtrade.

Tips:

Natural cosmetics

Natural cosmetics is a growing niche market segment which represents another opportunity for suppliers of natural ingredients. What classifies as natural cosmetics is currently defined by private-sector standards, specifically COSMOS and NATRUE. More recently, the International Organization for Standardization (ISO) has started to develop its own definitions.

Virtually all cosmetics, those that are certified as natural and those that are not, can use natural ingredients. Nevertheless, certain companies may see marketing advantages to using certified Natural cosmetics and certifying the finished products.

Essentially, cosmetics can be certified Natural if they contain a certain amount of natural ingredients. They also need to follow the guidelines that the aforementioned standards set for permitted ingredients. The standards also specify guidelines for the processes and additives that companies can use to develop natural cosmetics. As a supplier, you need to follow these guidelines so your buyers can use your ingredients in natural cosmetics.

There is no formally adopted legal definition of a natural ingredient. The REACH regulation has come closest to such a definition and may be used as a reference for a minimum legal definition. ISO and the private standards have developed their own non-legally binding definitions.

There are initiatives to develop an international standard for natural and organic standards; for example, as developed by NATRUE and COSMOS.

The International Organization for Standardization (ISO) has launched its standard for Natural and Organic Cosmetic Ingredients and Products (ISO 16128, Parts 1 and 2). This development means that you can use the standard for self-certification as well as future independent certification. Part 1 of this standard provides guidelines on definitions of natural ingredients. Part 2 was launched in 2017 and defines eight different indicators to standardise the measurement of natural and organic content.

Some buyers of cosmetic ingredients expect that private-sector standards will continue to remain the standard in the European Union until it introduces European legal standards. The ISO standards are not yet widely used. However, these standards are an option for small producers to whom certification is too expensive. Moreover, upcoming changes in EU cosmetics legislation will incorporate rules on organic and natural product labelling which might be based on ISO standards.

Tips:

  • Include the natural character of your product in your marketing tools. Buyers are interested in products with a story. Make sure that it is a true story: do not make any claims without scientific evidence.
  • You can bypass the need for Organic and Natural certification if you adopt good practices in your supply chain and communicate this fact clearly. Not every customer is willing to pay extra for certification. However, you have to find out what your customer wants.
  • Make sure that your product is traceable and your production process transparent. You need to show a deep understanding of your value chain. A certificate of origin can also increase security for buyers.
  • Take a look at the list of companies that have already obtained finished product certification. These lists are provided on the standard websites. Match the list to the ingredient that you offer to help you decide whether you want to get ingredient approval or certification.
  • Use the ISO standard for self-certification if Natural or Organic certification is beyond your current capacities. This standard is less demanding than the certification standards and can be a first step towards certification.

Organic

As is the case for natural cosmetics, organic cosmetics represent a niche segment. They are also defined by private-sector standards. Cosmetics are organic if they contain a specified amount of organic ingredients.

The COSMOS standard is becoming the dominant standard for cosmetic products in Europe. According to industry sources, 80–90% of organic brands use the COSMOS standard.

Apart from certifying a cosmetic end product, producers can also choose to use Organic certified ingredients. An added advantage to Organic certification is that buyers can trace the ingredients back to the source. However, you do not need Organic certification to achieve traceability. Organic certification is less important for some segments, such as fragrances.

Private-sector standards use European Union legislation on organic production and labelling of food products as a basis for organic labelling of cosmetic ingredients. Certifiers for ingredients for cosmetics include:

The difference between organic and natural cosmetics is not always clear. Even though the market for organic cosmetics is growing strongly, the market for Organic certified cosmetic ingredients remains limited. This means that you might need to sell your certified ingredients without the organic premium if you cannot find a buyer interested in Organic certification.

Tips:

  • Determine the buyer interest in an Organic certified version of your ingredient before complying with Organic certification. Visit and participate in trade fairs such as Vivaness in Germany to test whether the market is open to your product, obtain market information and find potential business partners.
  • Determine the potential size of the market for your Organic certified ingredient. Try to find out whether you can recover investment costs coming from the certification of the ingredient.
  • See the websites of certification standards, such as the authorised certifiers list from COSMOS for an overview of monitoring bodies.
  • See our study of Trends for natural ingredients for cosmetics for additional information on the organic trend.

Fair production

Fairtrade is increasingly popular in cosmetics, also because consumers recognise Fairtrade labels from food products. Cosmetic manufacturers can certify the final product but more often choose Fairtrade certified ingredients to support their brand image. In that case, the final cosmetic product is not certified.

Especially in the United Kingdom, consumers increasingly demand natural cosmetic ingredients with certified Fair production. They are more and more interested in social sustainability. Examples include:

More importantly, European consumers want to know where cosmetic ingredients come from. They want to hear stories about the people producing these ingredients. You can exploit this trend by using fair production methods in your marketing story.

Tips:

Please review our market information disclaimer.

Follow us for the latest updates