What requirements must natural food additives comply with to be allowed on the European markets?

Natural food additives must be safe for human consumption and packaged safely to enter the European market. This means you must have a food safety management system in place as an exporter to become successful in Europe. Offering traceable and sustainable products is also becoming more and more important in light of the European Green Deal. Expect buyers to demand proof of your product’s traceability, safety and quality before they will buy from you.

1. What are mandatory requirements for natural food additives?

As an exporter of natural food additives, you must ensure the safety of your products for use in the European market. When exporting to Europe, you must comply with the legally binding requirements of the European Union (EU). The most crucial requirements are related to safe trade in chemicals and food safety. 

Food safety

To enter the European food market, you must comply with several regulations that guarantee food safety. One of these is the General Food Law and its Regulation (EC) No 178/2002. This law mainly sets requirements for traceability, hygiene, and control. Compliance with this legislation ensures that your natural food additives are safe to eat and that legal limits for food contaminants are not exceeded. 

Important for the control of food safety hazards throughout the whole supply chain is the implementation of food safety management based on Hazard Analysis and Critical Control Points (HACCP) principles. HACCP planning consists of consecutive steps to:

• identify food safety hazards; 
• determine how you can control them (the so-called Critical Control Points or CCPs); 
• setting corrective measures for when you cannot guarantee the safety of the foods produced.

As part of its efforts to protect its consumers, the EU carries out regular official controls at the border and at all further stages of marketing. In case of non-compliance with the European food legislation, individual cases are reported through the Rapid Alert System for Food and Feeds (RASFF), which is freely accessible to the general public. In most cases of non-compliance, European importers will not pay for the product or demand their money back. Additionally, a food safety issue will damage your reputation on the market.

Be aware that repeated non-compliance with European food legislation by a particular country might lead to special import conditions or even suspension of imports from that country. Those stricter conditions include laboratory tests for a certain percentage of shipments from specified countries. 

For instance, the European Commission has banned titanium dioxide (E 171) as a food additive in the EU as of 2022. This is the result of an updated safety assessment by the European Food Safety Authority (EFSA) as it is not considered safe as a food additive and genotoxicity could not be ruled out. Other examples of banned food additives in the EU are brominated vegetable oil (BVO) and Sudan dyes.

Legislation on food additives and flavouring

Regulation (EC) 1333/2008 sets rules for the use of food additives, including definitions, conditions of use, labelling, and procedures. In addition to the regulation, two of its annexes require your attention:

1. Annex II contains a list of food additives approved for use in foods and their conditions of use.
2. Annex III contains a list of food additives including carriers approved for use in food additives, food enzymes, food flavourings, nutrients and their conditions of use.

Every EU-approved food additive gets an E number. Food additives with an E number have passed safety tests and have been approved for use. The safety evaluations of food additives are done by the expert panel on Food Additives and Flavourings (FAF) of the European Food Safety Authority (EFSA). They examine all relevant scientific data, considering chemical and biological properties, potential toxicity, and estimates of human dietary exposure. Using this information, the panel makes conclusions about the safety of the intended uses of the food additive for consumers.

Regulation (EC) 1334/2008 sets the rules for the use of flavourings in and on foods. Natural ingredients such as oleoresins, essential oils and some extracts are classified as flavourings and must comply with this regulation.

Note that European custom authorities will not allow food products on the market if they contain undeclared substances (i.e., adulterants) or additives or flavourings which are not permitted in the European Union.

Regulation on maximum levels for contaminants and pesticide residues

Your products must be safe for consumption and must not be contaminated by:

• physical elements (e.g., plastic residues, metal and dirt);
• chemical elements (e.g., pesticides); or 
• biological elements (e.g., bacteria). 

These contaminants could be substances unintentionally added to your product during the stages of production, processing, or transport, or due to environmental contamination. 

The European Union has implemented regulations to control and minimise the presence of contaminants in food. Of importance are:

• Regulation (EC) 396/2005 which sets Maximum Residue Levels (MRLs) for pesticides in or on food;
• Regulation (EU) 2023/915 which sets maximum levels for certain contaminants in food, including mycotoxins, metals and processing contaminants. 

These restrictions on raw materials also extend proportionally to derivative products, such as extracts and food additives. Products containing pesticides or contaminants above the permitted level will be withdrawn from the market. 

Conditions for the use of extraction solvents

To ensure safety for consumers, the use of extraction solvents in the production of foods is regulated by the European Union:

• Regulation (EU) No 231/2012 outlines specific guidelines for the use of extraction solvents in food additives with an E number. For instance, the regulation describes that guar gum (E 412) may be partially hydrolysed by either heat treatment, mild acid or alkaline oxidative treatment for viscosity adjustment. The regulation also sets purity criteria, establishing maximum levels for solvent residues, whether used individually or in combination.
• Directive 2009/32/EC establishes a list of permitted solvents for all other foodstuffs and food ingredients. Annex I contains a list of authorised extraction solvents, their conditions for use and maximum residue limits. 

European buyers usually verify compliance to the rules by checking information on extraction solvents and residue levels in your Certificate of Analysis (CoA - for an example, see this CoA of Grionia simplicifolia).

2. Classification, Labelling and Packaging (CLP)

Some natural ingredients such as certain essential oils are classified as hazardous. To ensure safety during transport and handling, special packaging must be used and warning labels must be included on the packaging. 

Regulation (EC) No 1272/2008 sets out the rules on classification, labelling and packaging (CLP) of substances and mixtures. This CLP regulation applies to food additives and flavours. The aim of this regulation is to identify hazardous chemicals, inform users about their hazards using standard symbols and phrases and provide rules on packaging. 

In December 2023, the European Commission reached some preliminary agreements on the revisions of the CLP regulation, including classifying essential oils as ‘potentially harmful chemicals’. The EU Parliament has already proposed an exemption for “renewable substances of botanical origin”, such as essential oils. The European Parliament is now in the process of adopting the new regulation. 

If your product is classified as hazardous, your Safety Data Sheet (SDS)  as well as your label must include the relevant safety phrases, risk phrases and hazard symbol. Risk phrases indicate the main risks and hazards, while safety phrases indicate the safety measures that need to be taken because of those risks and hazards.

Figure 1: Example of hazard symbol required for clove oil

Source: ECHA, 2023

Other labelling requirements

You are obliged to label your products if you want to export them to Europe. Your product needs to be labelled so European buyers as well as customs authorities, for example, can trace the origins of your product. Another reason is to ensure safety during transport and storage. 

In addition to complying with the CLP Regulation, you must apply common export labelling rules. EU’s labelling requirements are outlined in the EU’s food additives and flavourings legislation: Regulation (EC) No 1333/2008. Whether or not your product is intended for sale to the final consumer determines what labelling requirements you must comply with. This is outlined in chapter IV of the regulation, under Articles 21, 22 and 23.

In general, you must ensure that your labels include the following information in the English language, unless your buyer indicates otherwise: 

• Product name; 
• Batch code; 
• Whether the product is destined for use in food products; 
• Place of origin; 
• Name and address of exporter; 
• Date of manufacture; 
• Best-before date; 
• Net weight; 
• Recommended storage conditions. 

If you offer Organic certified ingredients, you should also add the name/code of the certifier and the certification number. 

International treaties to export natural ingredients: CITES and Nagoya Protocol 

If you want to export natural ingredients as food additives, you also need to comply with international treaties. These are especially important if you produce wild-collected ingredients. 

You need to comply with the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). CITES aims to protect endangered plants and plant products by regulating their trade. This convention 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 the EU wildlife legislation, 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 you are exporting to. For instance, if you want to export to the Netherlands, you can apply for the CITES import document (in Dutch) at the Netherlands Enterprise Agency, RVO.

European companies adopt diverse strategies when addressing CITES-related concerns. Certain companies avoid utilising raw materials enlisted in CITES, whereas others insist that species listed in CITES should originate from cultivation rather than wild collection. In all cases, suppliers are responsible for complying with current law and international standards, including CITES permits. As a supplier, it is also your responsibility to have the necessary documentation in place. European companies typically collaborate with you to acquire information and ensure adherence to EU regulations.

You also need to determine if and how the Nagoya Protocol of the Convention on Biological Diversity (CBD) applies to your product. This protocol aims to make sure the benefits of genetic resources and traditional knowledge are shared in a fair way. It provides guidelines for accessing and utilising genetic resources and traditional knowledge in Access and Benefit Sharing (ABS) agreements. ABS is especially important for wild-collected ingredients. 

The European Union is a signatory of the protocol. Regulation EU 511/2014 sets the rules for the implementation of the Nagoya Protocol at the EU level. Many other countries have signed this protocol and adopted it into national law. If your home country did as well, you need to comply with these national laws. European companies are legally required to follow those laws that are in force in your country regarding access and benefit sharing. Your buyers will expect you to be aware of and compliant with your country’s regulations on this topic.

Certain European companies require their suppliers to acquire the Internationally Recognized Certificate of Compliance (IRCC) from the Access and Benefit Sharing Clearing House (ABSCH). This certificate verifies that companies have legal access to genetic resources in accordance with the Nagoya Protocol. It is commonly required from suppliers in countries identified with a high risk of non-compliance with ABS regulations.

Figure 2: Video – The Nagoya Protocol and ABS, simply explained

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

Regulation (EC) No 1907/2006 is concerned with the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The REACH system aims to ensure a high level of protection of human health and the environment, including the assessment of hazards in substances. REACH is especially relevant for essential oil exporters.

However, from a legal point of view, essential oils for food are not subject to the same REACH documentation requirements as essential oils for other applications, such as fragrances. The European Union legislation on REACH requires suppliers of essential oils for these alternative applications to provide a lot more documentation. Essential oils for flavourings are exempt from REACH. 

Nonetheless, in practice, European buyers of essential oils for flavourings often have the same documentation requirements as buyers of essential oils for other uses. Since they do not know how their customers will use the essential oil, they need to have all the documentation required for different potential applications, including flavourings and fragrances. 

Note that exporters that supply less than 1 tonne annually do not need to register their product under REACH. This saves them a considerable administrative burden. The reason that these exporters can still supply to Europe is related to an underlying safety principle of REACH: greater quantities that are manufactured or imported pose greater risks to human health or the environment. A chemical substance that is imported or manufactured by a European company at less than 1 tonne per year falls outside the scope of REACH.

3. What additional requirements and certifications do buyers ask for in the natural food additives sector?

Many buyers have additional requirements which go beyond legislation. These are mainly focused on documentation requirements, sustainability, food safety management, and quality. 

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 and specifications. 

European buyers of natural ingredients 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 you need to include in these documents.

Table 1: What is contained in the Safety Data Sheet (SDS), Technical Data Sheet (TDS) and Certificate of Analysis (CoA)

Source: ProFound 

Quality management and food safety certifications

Food safety is a top priority in all European food sectors. You can therefore expect European buyers to request extra guarantees in the form of certifications. European buyers of natural food additives often require their suppliers to have the ISO 9001 certification on quality management systems and the ISO 22000 certification on food safety management. 

In addition, for many European buyers the implementation of standards and certifications recognised by the Global Food Safety Initiative (GFSI) is a minimum requirement. The most commonly used food safety management systems in Europe are FSSC 22000, BRCGS and IFS.

For some buyers, especially for large European companies, quality management requirements also apply to the production of the raw materials. In such cases, buyers want to ensure that the raw material used to produce the corresponding natural food additive is cultivated under Good Agricultural Practices (GAP). One of the most common certification schemes used in this regard is Global G.A.P. The Farmer Sustainability Assessment (FSA) of the SAI Platform is another popular tool used by European companies to evaluate quality management in raw materials production.

Figure 3: Examples of food safety certification

Source: standards websites

Table 1: Most important food safety and quality management certifications requested by European buyers

Source: ProFound

Quality requirements: adulteration, purity and consistency

Adulteration (the intentional addition of undeclared substances to a product) is a serious issue in the natural food additives trade. Adulteration causes the product to become unusable for the buyer. It loses the necessary properties to fulfil its intended function, and purification is usually either impossible or too costly. Strict controls are in place in Europe to detect potential adulterants. If adulteration is detected, you as a supplier will not be paid for your products and you will lose business with your buyer.

For instance, essential oils for food must be 100% pure (i.e., not mixed with any other essential oils that have similar characteristics) and 100% natural (i.e., not adulterated through the addition of any chemicals). If you dilute an essential oil with solvents, the product must be called a flavour or you must state that the oil is diluted (e.g., 20% in Propylene Glycol). When you have mixed your essential oils, you should call them a blend of essential oils. 

European buyers generally send samples to laboratories to analyse them. These laboratories continuously improve their techniques to determine the purity of products. In case there are undeclared substances in your product, it is very likely they will be detected.

In addition, buyers appreciate quality consistency over the year through standardisation. They expect suppliers to standardise products by establishing Standard Operating Procedures (SOP) for collection/harvesting and processing practices (e.g., timing of harvest and blending early and late crops). Often buyers prefer a large volume with a consistent quality level over smaller batches of different qualities.

Packaging requirements 

Packaging requirements can differ from buyer to buyer, and therefore must always be agreed with your buyer. In general, European buyers demand high-quality ingredients. To meet these high requirements, you should preserve the quality of your products by always: 

• Using packaging materials that do not react with your product. 
• Storing your product in a dry, cool, and odour-free environment. 

In the specific case of handling essential oil, make sure to always use United Nations approved packaging for dangerous goods.

Transparency and sustainability requirements

The EU is committed to environmental sustainability and sustainable growth, something it has made clear in the European Green Deal (EGD). As part of the EGD, new laws are proposed to increase the responsibility of European manufacturers to explain where and how products are produced and what impacts these have on people and the environment. 

An example of these legislative changes is the proposal for a Directive on corporate sustainability due diligence, which was adopted by the European Commission in February 2022. The new rules will ensure that businesses address adverse human rights and environmental impacts of their actions, including their value chains inside and outside Europe. This directive proposal is in line with the Farm to Fork strategy, part of the European Green Deal. The Farm to Fork strategy aims for fair, healthy and environmentally friendly food systems across Europe.

A transparent supply chain is key to deal with sustainability concerns. Since 2021, Regulation (EU) 2019/1381 sets the rules on the transparency and sustainability of the EU risk assessment in the food chain. While this regulation brings notable changes to the approval process for items such as food additives and flavourings, its direct impact on your company is improbable. 

Nevertheless, European buyers face growing pressure to ensure their supply chains are sustainable. As such, one of the main aspects for European buyers to choose product suppliers is a traceable and transparent supply chain. They want to have guarantees that a product they buy matches product specifications and can be traced back to the source. This might mean that you need to put more rigorous traceability systems in place to be able to deliver the information that your buyers demand of you. It also means you should have information on production and labour practices, as well as environmental issues in your chain. 

Buyers expect their suppliers to provide them with all the necessary information. Remember that such information is increasingly digitalised, making it important to follow this trend. Digitalising sourcing information provides improved transparency, increases access to information and statistics, and allows for more efficient purchase and payment processes. At the same time, it puts additional demands on your company to collect and disclose data.

European buyers may also specifically request that you comply with their code of conduct. Most such codes are based on the UN Global Compact principles or Ethical Trading Initiative Base Code and focus on issues such as human rights and fair working conditions and wages. Buyers expect their suppliers to follow these codes of conduct and often require confirmation in writing as part of business contracts.

Companies with global supply chains use EcoVadis and/or the Sedex Members Ethical Trade Audit (SMETA) to assess and audit their suppliers. Both sustainability reporting systems are recognised worldwide. EcoVadis covers four sustainability topics: environment, labour and human rights, ethics and sustainable procurement. As a company, you are either asked by your customers to undergo an EcoVadis assessment or you do it voluntarily. Doing it voluntarily serves as a check and external recognition of your sustainability status as a company. The assessment consists of a questionnaire tailored to the size and products of your company.

SMETA on the other hand is a social auditing methodology. Becoming a Sedex-certified member can give you a big competitive advantage if you wish to supply these large companies. Although SMETA is still a voluntary standard, it is likely to become a basic industry requirement in the coming years.

4. What are the requirements and certifications for natural food additives niche markets?

Verifying and/or certifying sustainable production represents a niche market in the natural food industry. However, it can add value to your product. Organic certification is the most common standard in the EU market for natural food additives. Other social and environmental sustainability standards and requirements include fair trade standards. 

Certifying your ingredients may help you to prove the traceability of your products, as this is verified and documented by an independent third-party auditor. See the main certification standards in the table below. 

 Table 2: Most important product certifications requested by European buyers

Source: ProFound

Although the above-mentioned certifications are the most commonly used in the natural food additives industry, requirements may vary by buyer. Therefore, before getting certified you should talk to your buyers and verify their needs.

Organic

For certain European companies, organic certification is a prerequisite to enter the market, as they only deal with organic products. Other companies may provide a range of products including both conventional and organic ingredients.

If you want to market organic ingredients to Europe, you need to comply with European requirements on production and labelling of organic products. In January 2022, the new EU organic regulation (EU) 2018/848 entered into force. This regulation adds new checks for imported organic products. Compliance can entail a major shift in your company’s processes. You need to move to permitted pesticides and fertilisers, control weeds naturally, implement a full traceability and internal control system and switch to only use permitted solvents during extraction (water, steam, or organic alcohol).

In the European Union, a product can have the organic production logo if it has been certified, and only if at least 95% of the ingredients from agricultural origin are organically produced . Note that only certain food additives may be used: check the positive list of additives (Part A of Annex V).

Kosher and Halal

Although actual demand for Kosher and Halal products is small, demand for certification of compliance against these religious standards is increasing. Kosher and/or Halal Certification allows food manufacturers to use the ingredients in Kosher and Halal products. European buyers aim to prevent exclusion from these markets. Many European buyers therefore now require Kosher and/or Halal certification. 

For instance, Halal certification for gum arabic requires cleaning procedures according to Islamic law. Alcohol cannot be used in the processing. Certified Halal products must also be kept separated from “impure” products, such as products from pigs. A unified standard for Halal does not yet exist.

Social and environmental standards

European consumers and retailers are putting increasing pressure on companies to ensure their products are made according to social and environmental standards. Some European product manufacturers have made meeting environmental and social standards part of their policy and strategy. 

Whether or not European buyers of natural food additives are interested in certified ingredients depends on the type of product they produce and how they communicate their sustainability to their customers. If an ingredient makes up only a small share of an end-product, it is difficult to communicate its sustainability to consumers. This means that, in general, standards are used only incidentally for natural food additives.

ProFound – Advisers In Development carried out this study on behalf of CBI.

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