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

Cosmetic regulations are becoming stricter in Europe. Thus, suppliers of natural ingredients from developing countries must ensure they comply with European regulations. It is essential for suppliers to keep up to date with regulatory changes to ensure they have access to the European market.

1. What are the requirements?

Legally mandated requirements

Safety of cosmetics ingredients

Ensuring consumer safety is a top priority of the European Union (EU), and this is expected to continue for the foreseeable future. The Cosmetics Regulation (EC 1223/2009) is the main regulatory framework for cosmetic products on the European market. The regulation affects manufacturers and importers of cosmetic products as well as suppliers of cosmetic ingredients.

Cosmetic ingredients are covered by this regulation from different angles. Cosmetic manufacturers must provide a Product Information File (PIF), which includes a Cosmetic Product Safety Report. The report should include data on any animal testing performed by the manufacturer, its agents or suppliers relating to the development or safety assessment of the cosmetic product or its ingredients. This also includes animal testing performed to meet the regulations of third countries. Cosmetic manufacturers also need to provide information on the toxicological profile of the ingredients, their chemical structure and their level of exposure.

Suppliers of natural ingredients from developing countries should be prepared to provide data supporting no-animal-testing claims. They should also inform manufacturers of any animal tests relating to a development or safety evaluation having been performed. Suppliers of cosmetic ingredients from developing countries need to provide buyers with information on the properties and attributes of their ingredients.

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

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is the strictest law to date regulating chemical substances. Companies headquartered outside of the EU do not have to abide by this protocol. Instead, the legal responsibility lies with the importers established in the EU, or with the sole representative of a non-EU manufacturer established in the EU. However, exporters in developing countries are expected to abide by this law because they supply to European buyers who must abide by this law.

Importers which import more than 1 tonne of natural ingredients must register them with a REACH central authority. Natural ingredients that are not registered cannot be used in the EU, unless they are exempt. Naturally occurring and chemically unmodified substances, such as vegetables, are exempt from registration.

As a supplier, you can register new cosmetic ingredients yourself by establishing your company as a sole representative in Europe. This will give you more protection as a supplier, as you are not dependent on a registered importer. Note that REACH Registration costs and fees are expensive and may put a lot of pressure on smaller suppliers from developing countries.

The European Chemicals Agency (ECHA) can assist you in this process. You can contact ECHA to find consortia for your product, and you can join such a consortium by signing a letter of access and paying a contribution fee.

The UK has officially left the EU, so the EU Single Market and the Customs Union with EU law no longer apply to the UK. However, EU REACH regulation was brought forward into UK law on 1 January 2021, also known as UK REACH. To enter the UK, exporters of natural ingredients for cosmetics from developing countries must meet both UK REACH and EU REACH requirements.

Labelling and packaging

The Classification, Labelling and Packaging (CLP) Regulation (CE 1272/2008) aligns previous EU legislation with the Globally Harmonised System of Classification and Labelling of Chemicals (GHS). It is expected to promote regulatory efficiency and facilitate the global trade of chemicals and harmonised communication of hazard information.

Natural ingredients must be labelled and packaged in a way that protects workers, consumers and the environment. It is up to the suppliers to decide the classification of a substance or mixture.

The CLP Regulation supplements the REACH Regulation. It regulates the notification of classifications, the establishment of a list of harmonised classifications and the creation of a classification and labelling inventory.

According to the CLP regulation, the label should include the following:

• The name, address and telephone number of the supplier;
• The nominal quantity of a substance or mixture in packages made available to the general public (unless this quantity is specified elsewhere on the package);
• Product identifiers;
• Where applicable, hazard pictograms, signal words, hazard statements, precautionary statements and supplemental information required by other legislation.

Suppliers of natural ingredients from developing countries must ensure their batches are labelled according to the CLP Regulation. Information on potentially dangerous substances must be included in the Safety Data Sheets (SDS), as specified in the REACH regulation. Failure to comply with the CLP Regulation when exporting to the European market will result in European buyers refusing to trade with you.

Efficacy claims

Cosmetic companies regularly make claims to market their products. However, to protect consumers and to help them make informed decisions, cosmetic claims are governed by strict regulations in the EU. The same rule applies to cosmetic ingredients, especially natural ingredients, as they may have functional and active properties that cosmetic companies may use in their marketing materials.

Commission Regulation (EU) No 655/2013 states that claims for a cosmetic product (explicit or implicit) have to be supported by adequate and verifiable evidence. Commission Regulation (EU) No 655/2013 sets criteria for this evidence, with which companies must comply.

This can be challenging as an ingredient supplier, because you will be required to provide extra documentation to buyers proving the effectiveness of new ingredients. You can substantiate your claims by using scientific and marketing data that have already been published, experimental studies or consumer perception tests.

The Cosmetics Regulation (EC 1223/2009) requires manufacturers to provide a Product Information File (PIF) with technical data necessary for substantiating claims. Suppliers of natural ingredients from developing countries should provide technical and scientific data on the characteristics of their ingredients. There are also specific requirements related to claims regarding sunscreen products.

Cosmetic companies are increasingly making claims about natural ingredients in their products. It is expected that this part of EU regulation will become stricter.

Ensure you comply with Commission Regulation (EU) No 655/2013 when making claims about your ingredients if you want to export your products to the EU. All your claims must be substantiated by requested materials, such as experimental studies, consumer perception tests or already existing marketing materials.

Biodiversity and species protection

The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), also known as the Washington Convention, is a multilateral treaty. It aims to ensure that international trade in specimens of wild animals and plants does not threaten their survival. The CITES convention became part of EU law under Regulation (EC) No 338/97. You must therefore meet CITES requirements.

CITES has a list of plant species that you cannot export/import or for which export/import is restricted. Check if your product is listed in Annex A and Annex B of Regulation (EC) No 338/97. If it is listed, you must obtain an export permit from your country’s CITES authority.

Companies in Europe must also comply with legislation on Access and Benefit-Sharing (ABS). Suppliers of natural ingredients to the cosmetics sector must abide by ABS.

Biodiversity regulations such as CITES and ABS are becoming more important in Europe and other regions, and this is expected to continue. This can be a major challenge to natural ingredient suppliers in developing countries. However, it can also present an opportunity if suppliers integrate biodiversity and species protection into their ethical sourcing programmes, as this may help them gain access to the European market.

The UEBT Biodiversity Barometer describes the growing awareness among European consumers about the importance of biodiversity and species protection along with increasing demand for environmentally friendly products. As a result, cosmetic companies are focusing on the ethical sourcing of ingredients. This is resulting in biodiversity and species protection becoming more important to European buyers, and this is likely to become more important in the future.

Not legally mandated requirements

Technical documentation

Ensure your technical dossier is well organised and structured, as this is required under the regulations applying to exports to the EU. It is an important source of information about your ingredients and can be used as proof of compliance with relevant legislation.

A technical dossier contains documents such as Technical Data Sheets (TDS), Safety Data Sheets (SDS) and Certificates of Analysis (CoA). Table 1 shows what is contained in the SDS, TDS and CoA to help you prepare these 3 important pieces of documentation.

Table 1: Contents of SDS, TDS and CoA

Safety Data Sheet (SDS)	Technical Data Sheet (TDS)	Certificate of Analysis (CoA) which matches
Product description	Product description	Data mentioned in the TDS
Product classification	Product classification	Pre-shipment samples approved by the buyer
Hazard identification	Quality analysis	Contractual agreements with the buyer
Information on safety measures	Information on applications
	Certificates

Source: Ecovia Intelligence

Having a comprehensive technical dossier is essential for you if you want to export to the EU. Failure to have 1 may result in European buyers refusing to trade with you and your reputation as a credible supplier of natural ingredients being damaged. For example, when a European buyer of natural ingredients for cosmetics was asked about the importance of documentation, they stated “Yes of course, if you do not have them (technical documentation), there is not going to be a sale at all”. It is very important that you invest a substantial amount of time and resources to prepare a well-organised and structured dossier.

2. What additional requirements do buyers often have?

Sustainable sourcing & CSR

Sustainable sourcing is becoming increasingly important in the cosmetics industry. There is an increasing push towards sourcing raw materials according to ethical practices. Many cosmetic companies and ingredient buyers consider the traceability of natural ingredients and the extent to which they have been sourced sustainably. Some may also actively seek to improve the sustainability of the ingredients they use.

There are some voluntary standards catering to this trend. The Union for Ethical BioTrade (UEBT) certifies natural ingredients that are sourced with respect for biodiversity and the environment. The Roundtable on Sustainable Palm Oil (RSPO) has a standard for sustainable sourcing of palm oil. The Initiative for Responsible Carnauba is working to ensure the responsible production of carnauba, which is native to Brazil. The Responsible Mica Initiative was introduced in 2017.

Companies are expected to provide greater transparency regarding the traceability and sustainable production methods of their ingredients. In the coming years, ethical sourcing is expected to become more important in the cosmetics industry. For example, recent research has found that sustainability is increasing in importance for businesses, especially around environmental, social and ethical performance. Suppliers of natural ingredients from developing countries should ensure their ingredients are traceable. Those that do not will find this trend a risk, as they may not meet buyer requirements.

Table 2: Most important certifications requested by buyers of natural ingredients for cosmetics

Name of certification	Type	Cost for companies	Most used in these European end market(s)	Further information on getting certification
COSMOS	Natural and Organic	Dependent on factors such as the type of certification, the number of natural ingredients and company sales figures.	Germany France Italy The UK	See the applying for certification part of the certification section of the COSMOS website for further information about getting certification.
NaTrue	Natural and Organic	The label fee is EUR 220 per certified product for a 2-year certificate. If more than 100 products are certified, the label fee is EUR 170 per certified product for a 2-year certificate.	Germany France Italy The UK	See the certification and approval process section on the NaTrue website for more information about getting certification. See the NaTrue approved certifiers section on the NaTrue website to find approved certifiers.
Fairtrade International	Social aspects	Certification and license costs are dependent on factors such as product standard, product, quality, form, product characteristics, country/region and producer scope.	Germany France Italy The UK	See the get certified and get licensed sections on the Fairtrade website for further information about getting certification.
Fair For Life	Social aspects	Certification costs are dependent on factors such as the size and complexity of the supply chain, the type of certification sought, the location of operation and producers and whether you have other certification.	Germany France Italy The UK	See the become certified section on the Fair For Life website for further information about getting certification.
FairWild	Social aspects (wild harvested)	Certification costs are dependent on factors such as location, size and complexity of operations.	Germany France Italy The UK	See the approved control bodies and accreditation sections on the FairWild website for further information about getting certification
UEBT	Ethical sourcing and biodiversity	Certification and claims fees are dependent on company turnover.	Germany France Italy The UK	See the UEBT certification bodies section on the UEBT website for further information about getting certification.

Source: Ecovia Intelligence

Quality management

Quality management standards are becoming increasingly recognised by European buyers of natural ingredients for cosmetics. By adopting a specific quality management standard, you will gain credibility, as it shows buyers that you are trustworthy and that you consider the quality of your ingredients important. Adopting quality standards can also help suppliers of natural ingredients from developing countries ensure batch-to-batch consistency and help to show compliance with mandatory requirements.

Examples of standards which help to demonstrate the good quality of natural ingredients for cosmetics include:

• Good Agricultural and Collection Practices (GACP);
• Good Manufacturing Practices (GMP) developed by the European Federation for Cosmetics Ingredients; and
• If natural ingredients such as essential oils are used in perfumes you make, be required to follow International Fragrance Association (IFRA) standards.

Additionally, consider adopting quality standards for production methods, as they will help you enter the European market. Examples include:

• ISO 22000 and ISO 9001:2015 from the International Organization for Standardization (ISO);
• Food Safety System Certification (FSSC); and
• The Hazard Analysis and Critical Control Points system.

The importance of quality standards will increase in the future. European buyers face a lot of pressure from their customers to deliver high-quality raw materials. With stricter EU regulations and increasing demand for high quality products, buyers are looking for suppliers of raw materials that can ensure a consistent level of quality. Suppliers of natural ingredients for cosmetics should therefore consider adopting quality management standards and certification, as this is likely to increase their chances of entering the European market.

3. What are the requirements and certifications for natural ingredients for cosmetics niche markets?

Natural and organic cosmetics

Demand for natural and organic cosmetics is increasing in Europe. According to Ecovia Intelligence, the market was valued at EUR 3.9 billion in 2019. Cosmetic companies are increasingly developing certified products and/or incorporating certified ingredients into their formulations. Many cosmetic products and raw materials are becoming certified according to natural and organic standards.

The most common natural and organic standards are COSMOS and NaTrue. These standards have certification schemes for finished products and raw materials. There are about 25 other natural and organic cosmetics standards in Europe; they include Nature & Progrès, CCPB, Organic Farmers & Growers and Demeter. Most are adopted on a national basis, and the adoption rates are relatively low compared to COSMOS and NaTrue.

European buyers have reported a growing demand among cosmetic manufacturers and formulators for certified ingredients to meet the consumer demand for natural products. Natural and organic standards for raw materials will continue to become important in the future. Certifications, such as NaTrue and COSMOS, add credibility to raw materials and are seen as proof of quality. Ingredient buyers and cosmetic manufacturers often use these labels on their marketing materials and packaging.

Suppliers of natural ingredients for cosmetics should consider if there is a business case for them to get natural and organic cosmetics certification. Doing so is likely to increase their chances of entering the European market, as certification is attractive to European buyers.

Figure 1: Logos of popular natural and organic cosmetics certification schemes

Source: COSMOS and NaTrue

Fair trade

The fair trade standard was originally an agricultural standard. However, it is increasingly used on cosmetic products. For fair trade products, Fairtrade International has the most popular certification schemes. The Fairtrade standard is popular among suppliers in developing countries, as it is mainly designed for north-south trade. Other certification schemes include Fair for Life/For Life Certification, Ecocert Fair Trade and FairWild.

Suppliers of natural ingredients from developing countries should consider a fair trade standard, as it covers the social aspect of sustainable production. These claims are becoming increasingly popular among European consumers.

The trends of ethical certification will continue to increase in the future. Suppliers of natural ingredients in developing countries should therefore seek to have their products fair trade certified. Guru Nanak Oil Mills (U) Ltd., Uganda is an example of an exporter of fair trade certified shea butter to the European market.

In recent years, there has also been increasing demand for FairWild certified ingredients. Thus, suppliers are advised to consider obtaining FairWild certification for wild-harvested ingredients. EcoProducts is an example of a South African exporter of FairWild certified baobab oil to the European market.

Figure 2: Logos of popular fair trade certification schemes

Source: Various

This study has been carried out on behalf of CBI by Ecovia Intelligence.

Please review our market information disclaimer.