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

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The European Union’s (EU) regulations for natural health products are strict. Moreover, there are additional buyer requirements for natural ingredients. Suppliers of natural ingredients from developing countries must meet regulations and buyer requirements to access the European market.

1. What are the mandatory requirements?

This report provides an overview of requirements exporters of natural ingredients need to comply with when exporting to the European health products sector. Most natural ingredients for the health sector are used in supplements and herbal medicinal products. Exporters of natural ingredients from developing countries need to decide what segment they want to target and comply with the relevant regulations. You must follow requirements that apply to the cosmetics sector if you wish to be active in the aromatherapy sector.

Figure 1: Applications of natural ingredients for health products

Applications of natural ingredients for health products

Source: Ecovia Intelligence

Mandatory legal requirements for herbal medicinal products

You must comply with EU legislation (Directive 2004/24/EC) if your natural ingredients are to be used in herbal medicinal products.  If you fail to do this, you will not be able to enter the European market. You must also comply with ‘The rules governing medicinal products in the EU’ in addition to rules concerning any marketing claims that you make about the medicinal properties of the products.

The European Medicines Agency (EMA) is the agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in EU Member States. The EMA has a series of standards for the most widely used established ingredients for herbal medicinal products, known as community herbal monographs. You must comply with the EMA’s monographs if you are an established producer of an ingredient.

The EMA’s monographs state what claims European manufacturers can make about herbal medicinal products and ingredients used. You must therefore use the terminology of the claims made by manufacturers in your communication materials. When marketing your natural ingredients, give details about their use and advantages according to national legislation. This will help you make a stronger case in marketing your natural ingredients to European buyers.

New natural ingredients in the European market must be registered for use in traditional herbal medicinal products (THMP).  You must comply with this procedure if you are a supplier of new ingredients. If you fail to do so, you will be unable to enter the European market.

Tips:

  • Do not enter into an agreement with European buyers who have additional requirements if you cannot meet their requirements, as this will put your trading relationship at risk.
  • Check if your natural ingredients for health products are new. If so, you must register them. Visit the European Commission’s herbal medicines product page for information on how to do this.  
  • Visit the EPing website for an overview of country-specific measures that could affect the trade of natural ingredients for health products and that differ from the international standards. You can also find a list of contact persons per country appointed by the World Trade Organisation (WTO) here.
  • See CBI’s study on buyer requirements for natural ingredients for the cosmetics sector for more information on requirements for cosmetics.

Mandatory legal requirements for food supplements       

You must be compliant with EU food supplement legislation and the European General Food Law if your natural ingredients are to be used in food supplements. If you fail to do so, your natural ingredients will not be allowed on the European market.

Established ingredients for food supplements are listed in the Novel Food Catalogue, the Union List and the botanical list for food supplements. You must register your natural ingredients for use if they are not listed there. Natural ingredients not sold in Europe before 1997 fall under the EU’s Novel Food legislation. If this applies to your natural ingredients, you must have documentation in addition to safety and labelling approval before they can be used in food supplements.

You must also provide data on toxicological, microbiological and allergenic properties. The new Novel Food Regulation came into force in January 2018. You must follow this regulation. Ensuring food safety for consumers is extremely important to the EU, with EU regulation concerning food safety expected to become stricter in the coming years.

Tips:

Protection of Species and Biodiversity

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 plants and animals does not threaten their survival. The CITES convention became part of EU law under Regulation No 338/97.

If your natural ingredient is registered under Annex A and Annex B of EU Regulation (EC) No 338/97, you must obtain an export permit from your country’s CITES authority to trade it on the European market.

Companies in Europe also need to comply with legislation on Access and Benefit-Sharing (ABS). Suppliers of natural ingredients to the natural health products sector should ensure that they 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 for the foreseeable future. This can be a major challenge for natural ingredients suppliers in developing countries. However, it can also provide an opportunity if suppliers integrate biodiversity and species protection into their ethical sourcing programmes. This can help them access the European market.

Tips:

  • Visit the CITES website to learn more about CITES. This will give you a better understanding of what legal requirements are expected.
  • Determine whether your natural ingredients for natural products require import and export permits to enter the European market. Do this by checking if your natural ingredients are listed under CITES’ Appendices.
  • Contact the relevant CITES authority in your country if you require an export permit. Note that you might need an import permit from the country you are importing to. You can contact local CITES authorities for further assistance in such cases.
  • Regularly check for updates to EU Regulation No 338/97 because regulation is always subject to update and change. You can do this by visiting the eur-lex.europa.eu website.
  • Determine if the sourcing of your natural ingredients requires compliance with Access and Benefit-Sharing legislation in your country. You can do this by visiting the CBD website for information.
  • Visit the Species+ website which is designed to help implement CITES and use its features. Doing so will help you comply with a mandatory requirement that (if applicable) you must comply with to enter the European market.

Buyer requirements

Documentation

European buyers of natural ingredients require exporters to provide them with well-structured and organised product and company documentation. Buyers use it to verify whether you meet their requirements.

For example, a buyer stated in an interview that “we require a lot of documentation from the suppliers to make sure that goods meet our specifications”. Additionally, when asked about the need for documentation, one buyer said that “documentation is important”, with another buyer stating, “we need to have these”, and yet  another stating: “yes, 100 percent”.

Providing well-structured and organised product and company documentation will give you an advantage when trying to establish yourself in the European market from which you can develop long-lasting trading relationships with buyers. It also gives your business credibility as it makes you look organised and business ready.

European buyers of natural ingredients for health products usually expect exporters to provide them with a Safety Data Sheet (SDS), Technical Data Sheet (TDS) and Certificate of Analysis (CoA). Table 1 shows what information is contained in the SDS, TDS and CoA to help you prepare these three 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 buyer

Hazard identification

Quality analysis

Contractual agreements with buyer

Information on safety measures

Information on applications

 

 

Certificates

 

Thus, you need to prepare an SDS, TDS and CoA for your natural ingredients and have them ready for European buyers. It is important to note that you will need to invest time and resources in preparing the documentation buyers require. You should let buyers know if you already have relevant documentation. Documentation is expected to remain important for European buyers for the foreseeable future, especially when EU regulation is getting stricter.

Tips:

  • Meet European buyer demands for documentation concerning your natural ingredients for health products.
  • Ensure that any samples that you send buyers match your documentation. This is because samples are assessed against documentation. For example, do not send samples of lower quality than what you have stated in your documentation.
  • Review the example Safety Data Sheet, Technical Data Sheet and Certificate of Analysis for organic baobab powder.

2. What additional requirements and certifications do buyers in the natural ingredients for health products sector ask for?

European buyers of natural ingredients for natural health products have additional requirements beyond the mandatory requirements set by the EU. You must meet additional buyer requirements to successfully enter and trade on the European market. Failure to do so will only make it difficult for you to enter and trade on the European market, which is becoming increasingly competitive. Table 2 lists the most important certifications requested by buyers in the European natural ingredients for health products sector.

Table 2: Most important certifications requested by buyers in the European natural ingredients for health products sector

Certification name

Type

Cost for companies

Most used in European end-market(s)

Further information on obtaining certification

ISO 22000:2018

FSSC 22000

Food safety

Certification costs will depend on factors such as your company’s business activities and location. 

Germany

France

Italy

The UK

See the ISO 22000:2018 food safety management systems webpage on the ISO website for further information on obtaining certification.

See the certification bodies section on the FSSC website for further information about obtaining certification.

ISO 9001: 2015

Quality management

Certification costs will depend on factors such as your company profile, sectors, annual turnover, number of sites and staff.  

Germany

France

Italy

The UK

See the ISO 9001:2015 quality management systems webpage on the ISO website for further information about obtaining certification.

EU Organic

Organic

Certification costs will depend on factors such as your company profile, business activity, number of sites, who you work with, and country/region.

Germany

France

Italy

The UK

See the organic agriculture Europe quotation section on the Ecocert website for further information about obtaining certification.

FairWild

Social aspects (wild harvested)

Certification costs will depend on factors such as location, size and complexity of operations.

Germany

France

Italy

The UK

See the approved control bodies and accreditation section on the FairWild website for further information about obtaining certification.

Fairtrade International

Social aspects

Certification and license costs will depend on factors such as the product standards, product, level of quality, form, product characteristics, country/region and producer scope.

Germany

France

Italy

The UK

See the get certified and get licensed section on the Fairtrade website for further information about obtaining certification.

Fair For Life

Social aspects

Certification costs will depend on factors such as the size and complexity of supply chain, type of certification sought, location of operations and producers and whether you have other certifications.

Germany

France

Italy

The UK

See the become certified section on the Fair For Life website for further information about obtaining certification.

UEBT

Ethical sourcing and biodiversity

Certification and claims fees will depend on the company’s turnover.

Germany

France

Italy

The UK

See the UEBT certification bodies section on the UEBT website for further information about obtaining certification.

Source: Ecovia Intelligence

Ensuring quality

If you are an exporter of natural ingredients for food supplements, compliance with Hazard Analysis and Critical Control Points (HACCP) is an additional  requirement that is frequently imposed by buyers. This is because compliance with this demonstrates that your natural ingredients are of high quality. Thus, consider becoming HACCP compliant, as it will give you an advantage when you are seeking to enter the European market.

A second common additional buyer requirement from European buyers of natural ingredients is certification of a food management system based on HACCP. This is because having certification suggests high quality of natural ingredients for health products. You should therefore consider obtaining certification, with the most relevant being:

  • International Organization for Standardization (ISO) 22000 food safety management system certification and ISO 9001:2015  and quality management systems certification;
  • Food Safety System Certification (FSSC 22000) which is based on ISO 22000 and is aimed specifically at food manufacturers.

Additionally, European buyers often require natural ingredients for natural health products to meet:

  • British Retail Consortium Global Standard for Food Safety (BRCGS) standards which provide technical standards for food safety;
  • International Featured Standards (IFS) which provide several standards concerning food safety.

As such, you should try to determine whether you could benefit from compliance with meeting BRC and IFS standards. Note that such compliance will make you more appealing to European buyers.

Consumers are demanding natural health products and the natural ingredients used in them to be of higher quality. In turn, European buyers of natural ingredients require high-quality natural ingredients. Furthermore, EU legislation ensuring the quality of natural ingredients for natural health products is getting stricter. You must therefore meet additional buyer requirements concerning good quality.

Quality is very important to European consumers and health product manufacturers who want to ensure they meet consumers’ needs. The importance of quality management in the health products sector is expected to increase in the future.

Figure 2: Examples of certifications and standards

Examples of certifications and standards

Source: Various

Tips:

  • Review the FAO Guidelines for the implementation for HACCP as it provides useful guidance about implementing HACCP.
  • Inform prospective European buyers about your compliance with standards and certification you hold demonstrating quality as it will make you more appealing to them.
  • Ensure you clearly highlight your compliance with standards and certification you hold in your sales and marketing materials. For example, by displaying the certification logos on your company website, marketing materials and product catalogue.

European consumers and retailers are putting increasing pressure on companies to ensure their products are made according to social and environmental standards. Regarding social standards, a European buyer of natural ingredients for health products commented: “we’ve got a lot of customers who require it… it gives us a bit of legitimacy and it’s something we value ethically”.

Additionally, meeting environmental and social standards is often part of a company’s policy and strategy. For example, when asked about the importance of meeting social standards, a European buyer commented: “we want to build a long-term relationship with our partners and that is why it is important that they earn fair money for their work, reflecting the value of their work”. Buyers have also stated that they use environmental and social standards in their marketing stories.

European buyers of natural ingredients are therefore requesting suppliers meet social and environmental standards. As an exporter, you can do this by gaining verification and certification proving you meet social and environmental standards.

One way to demonstrate environmental sustainability is to meet:

To prove you meet social standards acquire:

  • Fairtrade International standards which requires producers and traders to meet a range of economic, environmental and social criteria;
  • Ecocert Fair Trade which concerns adequate and safe working conditions, fair pricing and the empowerment and independence of producers along with good environmental practices;
  • Fair for Life standards which concerns certification programmes for fair trade, responsible supply chains and Corporate Social Responsibility.

Across Europe, there is growing consumer demand for ethically produced products. For example, in the UK ethical spending has hit record levels. The sector reached GBP 41 billion in 2019. According to Twenty Years of Ethical Consumerism Report, the sector is ten times larger than in 1999. This trend is expected to continue. As such, there is greater demand for natural ingredients for health products that meet social and environmental standards.

Figure 3: Examples of fair trade certification schemes

Examples of fair trade certification schemes

Source: Various

Tips:

  • Acquire verification and certification demonstrating your natural ingredients for health products meet social and environmental standards. This will help you find opportunities in the European market.
  • Inform prospective European buyers if your natural ingredients already meet social and environmental standards as it will give you an advantage in your bid to enter the European market.
  • Consider whether there is a business case for you to invest in social and environmental standards. This is especially important given that the demand for natural ingredients that meet social and environmental standards is expected to increase in the future. 

Ethical sourcing

Ethical sourcing is becoming important in the export of natural ingredients to the European market, offering an effective way to demonstrate that you are a sustainable supplier of natural ingredients. You can do this by meeting Good Agricultural and Collection Practices (GACP) guidelines.

GACP guidelines are important if your natural ingredients are collected from the wild. This is especially important if your natural ingredients are used in food supplements.

The importance of ethical sourcing is expected to increase in the future. The increasing awareness of European consumers about ingredients in health & natural products is a key driver of this trend. Exporters of natural ingredients from developing countries should ensure that they meet the principles of ethical sourcing.

Tips:

  • Meet industry standards for ethical sourcing. You can get details on the website of the Union for Ethical BioTrade
  • Meet and implement GACP guidelines. Additionally, ensure you have the relevant documentation proving that you meet GACP guidelines. This will make it easier for you to establish trading relationships with European buyers and enter the European market.
  • Find out if there is a business case for you to acquire FairWild certification.

Transparency and traceability of sourcing

European companies with health & natural products face a lot of pressure to ensure their supply chains are transparent and traceable. Many finished product manufacturers need to provide information related to ingredient authenticity, raw material origins and social risks in supply chains. Thus, buyers often choose suppliers with transparent supply chains as they need to be able to trace ingredients back to their source.

As an exporter of natural ingredients or health products to Europe, you should have information on production practices, labour practices and environmental issues. European buyers may request that you comply with their code of conduct or sign industry charters. Buyers expect their suppliers to provide them with all the necessary information.

Increasing demand for transparency and traceability puts additional demands on exporters from developing countries with regard to data collection and the disclosure of information. However, this can improve business relationships and create a sense of trust between suppliers of natural ingredients from developing countries and European buyers.

The importance of transparency and traceability in supply chains in the health products sector is expected to increase in the future. Growing awareness of European consumers is putting pressure on health products companies. Exporters from developing countries should expect this requirement to become even more important in the future.

Tips:

  • Acquire detailed information about the sources of your natural ingredients, particularly from growers and farmers. Know the exact sources of your natural ingredients and the people involved in handling them. European buyers want to know about the origins of natural ingredients and the processes and working practices involved in their production in addition to information about growers and farmers involved.
  • Use data gathering tools and systems to improve the traceability and reliability of your natural ingredients.
  • Be prepared to provide data on raw materials sources, processes and companies involved in the supply chain.
  • Register your company with the Supplier Ethical Data Exchange (SEDEX). This online platform provides a template of the typical information required. It also facilitates sharing this information with potential customers.
  • Use the transparency and traceability of your natural ingredients to create a marketing story for your products. For example, you could create a section on your website that gives  buyers an overview of your natural ingredients supply chain from farmer to European export destination. Indian exporter of turmeric Suminter India Organics is an example of a company doing this.

3. What are the requirements and certifications for natural ingredients for health products in niche markets?

Organic Ingredients

Across Europe, there is increasing consumer demand for organic products, a trend which is expected to continue. To meet that growing demand, many European buyers are demanding organic ingredients for their natural health products. Furthermore, organic certification is also viewed as a sign of quality.

Indeed, when asked about the need for organic certification, one European buyer stated, “organic certification is always needed”, with another buyer stating: “yes 100 percent, I don’t think any client would buy from us if it was not organically certified”. Another buyer said: “the vast majority of things we buy are organic, so they would need to be organic certified”. Producers in developing countries should therefore consider obtaining organic certification.

Certified organic ingredients are produced and processed using organic farming techniques, such as crop rotation, biological crop protection and the use of green manure and compost. You must meet EU regulations to trade and market your ingredients as organic on the European market. You can find information about EU organic certification on the website of the European Commission.

In January 2022 the new EU organic regulation (EU) 2018/848 will enter into force. This new regulation adds new checks for imported organic products. As a producer from a third country you must comply with this new regulation if you are supplying organic ingredients.

Several certification agencies can help you with the conversion to organic production. Once you are certified, many buyers will request a Certificate of Inspection (COI). Your natural ingredients cannot be marketed as organic products if you do not have a COI.

The demand for certified ingredients for health products in the European market is expected to continue to grow in the future. Indeed, sales of organic products in Europe have increased during the COVID-19 pandemic. Thus, exporters of natural ingredients from developing countries should consider organic certification when targeting the European market.

Figure 4: EU organic certification logo

Organic certification logo

Source: ec.europa.eu

Tips:

  • Consider converting to organic production methods and getting certification. This is particularly important due to the increasing demand for organic health products, a trend which  expected to continue.
  • Ensure you are compliant with the new EU organic regulation that comes into force in January 2022.
  • Ensure you have a Certificate of Inspection (COI) which proves your natural ingredients are organic is mandatory if you want to trade them on the European market.  Additionally, you should ensure your COI is up to date in light of the upcoming changes to be made by the EU that will come into force in February 2022.

  • Let prospective European buyers know if your natural ingredients already have a COI, as it makes you more appealing to them.
  • See the ITC Sustainability Map for a full overview of certification schemes in the sector.

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

Please review our market information disclaimer.

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