Association of Manufacturers and Formulators of Enzyme Products
AMFEP
The Association of Manufacturers and Formulators of Enzyme Products - Amfep - is a non-profit European industry association created in 1977.
ID: 25945099095-69
Lobbying Activity
Meeting with Vita Jukne (Cabinet of Commissioner Jessika Roswall)
30 Oct 2025 · The enzyme sector and views on the REACH revision, Bioeconomy strategy and Circular Economy act
Response to Circular Economy Act
28 Oct 2025
AMFEP, the Association of Manufacturers and Formulators of Enzyme Products, representing 90% of the EU enzyme market, welcomes the opportunity to comment on the Circular Economy Act call for evidence. This initiative represents an important opportunity to build on existing recognition of enzymes as key contributors to the EUs transition towards a circular and competitive economy. Contributing over 2 billion EUR to the EU economy, enzymes play a vital role as cross-sectoral enablers across numerous industries (food and feed, detergents, textile, pulp and paper, etc.). By enhancing efficiency in industrial processes and optimizing resource use, enzymes drive our transition from fossil to bio-based solutions. Enzymes directly support the Circular Economy Acts objectives by reducing reliance on raw materials, improving resource efficiency across value chains, reducing waste and enabling the use of byproducts in production cycles. Accelerating the EUs transition to circularity requires a risk-benefit approach that ensures innovative solutions are truly enabled and should stay coherent with existing legislation and upcoming key initiatives such as the Bioeconomy Strategy, Biotech Act, and revision of REACH. This will be critical to ensure EUs global leadership within the enzyme sector in the transition towards circularity. Please find our full response to the Call for Evidence attached.
Read full responseResponse to Food and Feed Safety Simplification Omnibus
14 Oct 2025
AMFEP, the Association of Manufacturers and Formulators of Enzyme Products, representing 90% of the EU enzyme market, welcomes the opportunity to comment on Commissions initiative to increase the competitiveness of EU farmers and the food and feed industry, as well as reduce the administrative burden on Member States authorities related to marketing authorisations of products. The food industry is one of the largest users of enzymes, with enzyme-enabled products representing a market worth more than 300 billion. Enzymes increase efficiency, reduce waste, and lower energy use in food processing and animal feed. The scoping document outlines several areas for targeted simplification measures, including the clarification related to the legal status of fermentation products manufactured using genetically modified micro-organisms (GMMs). AMFEP strongly supports this and calls for a targeted clarification to Regulation 1829/2003 indicating that food and feed products which are produced using GMMs in a contained used fermentation process (such as enzymes) constitute food and feed produced with GMOs and are therefore out of scope of the GM legislation. More generally, AMFEP supports the objectives of the Omnibus to enhance competitiveness and reduce the administrative burden. This requires a clear and consistent regulatory framework for enzymes, including a smooth implementation of the Food Enzyme Regulation (1332/2008) through the publication of the Union List of food enzymes and with appropriate transitional measures. Please read our full comments in the attachment.
Read full responseResponse to Towards a Circular, Regenerative and Competitive Bioeconomy
23 Jun 2025
AMFEP, the Association of Manufacturers and Formulators of Enzyme Products, representing 90% of the EU enzyme market, welcomes the opportunity to comment on the Bioeconomy Strategy call for evidence. The Bioeconomy Strategy is interlinked with other crucial pieces of EU legislation including the Life Sciences Strategy and the Biotech Act. Together, these present an opportunity to support the EU economy in its green transition by shifting from fossil to biological alternatives. Contributing over 2 billion EUR to the EU economy, enzymes play a vital role as cross-sectoral enablers across numerous industries (food and feed, detergents, textile, pulp and paper, etc.). By enhancing efficiency in industrial processes, optimizing resource use, and boosting biomass valorisation, enzymes drive key advances in the bioeconomy. This is particularly evident in sectors such as food production and detergents, where they enable more sustainable and cost-effective operations and make a significant economic contribution (300 billion in enzyme-processed food and beverages as well as 20 billion in enzyme-containing detergents). The attached document highlights the importance of recognising enzymes as distinct substances from other chemicals due to their unique role in supporting sustainable and biodegradable solutions. A balanced, risk-benefit regulatory approach is essential to fully realise their environmental and economic potential. To ensure a competitive and sustainable EU bioeconomy, the upcoming Bioeconomy Strategy should explicitly support the broader use and recognition of enzymes across value chains.
Read full responseResponse to Biotech Act
11 Jun 2025
AMFEP, the Association of Manufacturers and Formulators of Enzyme Products, representing 90% of the EU enzyme market, welcomes the opportunity to comment on the Biotech Act call for evidence. The Biotech Act is an opportunity to build on the earlier recognition of enzymes as contributing to sustainability and competitiveness in the March 2024 Commission Communication on biotechnology and biomanufacturing. These are even more relevant under the current geopolitical climate, in which the EU needs to remain competitive and resilient compared to other regions investing in biotech. Recognizing enzymes as distinct from other chemicals is vital for coherent, technology-neutral policy that aligns with the Biotech Act, bioeconomy goals, and supports a shift from fossil to biological alternatives. We address in the attached response several issues that are critical for the enzymes sector under the Biotech Act, to ensure there is no disruption in the current benefits to the EU bioeconomy, but also to encourage private sector investments remain in the EU - for keeping its global leadership in enzymes. Please find our full response to the Call for Evidence attached.
Read full responseMeeting with Taru Haapaniemi (Cabinet of Commissioner Christophe Hansen) and AB Enzymes
20 May 2025 · Role of enzymes in different production processes; regulatory changes affecting the enzyme sector
Meeting with Vilija Sysaite (Cabinet of Executive Vice-President Stéphane Séjourné)
13 May 2025 · Enzymes
Response to EU Life sciences strategy
17 Apr 2025
AMFEP, the Association of Manufacturers and Formulators of Enzyme Products, representing 90% of the EU enzyme market, welcomes the opportunity to comment on the EU Life Sciences Strategy. Enzymes are proteins produced in nature by all living organisms. They are a crucial element of life sciences and industrial biotechnology, with a scope of industrial applications across food, feed, and technical applications. Key challenges and barriers identified for the life sciences sectors include limited market uptake and commercialization as well as regulatory complexity. These barriers are also highly relevant for the enzyme sectors. Enzymes are widely used across sectors and so are subject to different legislation following their uses. The Life Sciences Strategy must provide a coherent way forward that is integrated with existing and future policies including the upcoming Biotech Act and Bioeconomy Strategy. Please find our full response to the Call for Evidence attached.
Read full responseResponse to Taxonomy Delegated Acts – amendments to make reporting simpler and more cost-effective for companies
26 Mar 2025
AMFEP, the representative association of manufacturers and formulators of enzyme products, support the option 1 proposed in Annex IX and Annex X - deletion of the additional requirement for substances of which CLP classification falls under Article 57 of the REACH Regulation. Respiratory sensitizers can be regarded as substances posing an Equivalent Level of Concern (ELoC) to substances listed in points (a) to (e) Article 57 (f) of the REACH Registration . Like many other proteins such as pollen and house dust, enzymes can act as respiratory allergens (i.e., if an enzyme is inhaled in dust or aerosol form, it may give rise to sensitization towards that specific enzyme). Despite of the hazard classification, enzymes have been safely used for more than 50 years in various applications. Throughout this period, AMFEP and its members, in collaboration with other trade associations, have been working to reduce and eliminate exposure to airborne enzyme dust or aerosols in order to minimize the risk of respiratory sensitisation. This includes developing guidance on the safe use and handling of enzyme products. Additionally, industry is continuously investing and investigating to minimize any risk at both consumer and industrial levels. We, therefore, support the option 1 proposed in Annex IX and Annex X deletion of the additional requirement for substances of which CLP classification falls under those hazard classes listed in Article 57 of the REACH Regulation. More generally, introducing uncertainty regarding uses of enzymes under Taxonomy would hinder Europes attractiveness for investments in enzyme supply chains at large and downstream user industries.
Read full responseMeeting with Hildegard Bentele (Member of the European Parliament, Rapporteur) and EuropaBio and
27 Feb 2025 · Biotech
Response to Delegated act on primarily used components under the Net-Zero Industry Act
20 Feb 2025
AMFEP, the Association of Manufacturers and Formulators of Enzyme Products, warmly welcomes that enzyme-based applications are listed as primarily used components in the draft Annex to the delegated act amending Regulation (EU) 2024/1735 as regards as regards the identification of sub-categories within net-zero technologies and the list of specific components used for those technologies. Enzymes have already been contributing to the reduction of CO2 emissions and hold significant potential to further support Europe'ss net-zero goals. Enzymes are proteins that speed up biochemical reactions essential for life, functioning as natural catalysts. They work under mild conditions, offering sustainable solutions for both nature and industry. Understanding their role is crucial for policymaking, especially in food, environmental, and technological contexts. In the draft Annex, enzymes are mentioned as final products and primarily used components for the Biotech climate and energy solutions net-zero technology as follows: Enzymes (such as amylase and cellulase) that are used to pretreat and convert feedstock into biofuels, bio-based chemicals, bio-based materials and bio-based products The above description can be read in a way that signals that the primary component of enzymes is limited to feedstock conversion by enzymes. Enzymes as enablers can be primary components for the reduction of greenhouse gas emissions (GHGs) in other energy-intensive processes: by catalysing chemical reactions, enzymes help cut down energy consumption (e.g., natural gas or electricity) across a wide range of sectors, such as textiles and pulp & paper. We believe that the contributions of enzymes are broader than the above description . We propose that the Commission should consider including more examples to show the potential of enzymes (however not as an exhaustive list) as enablers under the biotech and climate solutions net-zero technology. Specifically, to account for the climate benefits of using enzymes as processing aids to catalyse chemical reactions, we propose several edits to the list of final products and main specific components for the biotech climate and energy solutions net-zero technology (please consult the attached pdf for more information). More generally, we would like to draw the Commission's attention to the need to protect and support the manufacturing processes used to produce enzymes, such as modern biotechnology and fermentation techniques, within the EU. AMFEP consists of 29 members, covering 90% of the European market for enzymes and 80% of the global enzyme market with more than 40 sites across 10 Member States for manufacturing sites and R&D centers. It is critical to enhance manufacturing capacity to ensure that the EU remains a global leader in enzyme production. This could be done by supplementing the list of final products and main specific components with the following element: "The manufacturing processes used to produce enzymes, such as modern biotechnology and fermentation techniques.
Read full responseResponse to List of net-zero technology final products and their main specific components
20 Feb 2025
AMFEP, the Association of Manufacturers and Formulators of Enzyme Products, warmly welcomes that enzyme-based applications are listed as main specific components in the draft Annex to the implementing act supplementing Regulation (EU) 2024/1735 as regards the list of net-zero technology final products and their main specific components for the purposes of assessing the contribution to resilience. Enzymes have already been contributing to the reduction of CO2 emissions and hold significant potential to further support Europes net-zero goals. Enzymes are proteins that speed up biochemical reactions essential for life, functioning as natural catalysts. They work under mild conditions, offering sustainable solutions for both nature and industry. Understanding their role is crucial for policymaking, especially in food, environmental, and technological contexts. In the draft Annex, enzymes are mentioned as final products and main specific components for the Biotech climate and energy solutions net-zero technology as follows: Enzymes (such as amylase and cellulase) that are used to pretreat and convert feedstock into biofuels, bio-based chemicals, bio-based materials and bio-based products The above description can be read in a way that signals that the primary component of enzymes is limited to feedstock conversion by enzymes. Enzymes as enablers can be primary components for the reduction of greenhouse gas emissions (GHGs) in other energy-intensive processes: by catalysing chemical reactions, enzymes help cut down energy consumption (e.g., natural gas or electricity) across a wide range of sectors, such as textiles and pulp & paper. We believe that the contributions of enzymes are broader than the above description (Figure 1 and Figure 2). We propose that the Commission should consider to include more examples to show the potential of enzymes (however not as an exhaustive list) as enablers under the biotech and climate solutions net-zero technology. Specifically, to account for the climate benefits of using enzymes as processing aids to catalyse chemical reactions, we propose several edits to the list of final products and main specific components for the biotech climate and energy solutions net-zero technology (please consult the attached pdf for more information). More generally, we would like to draw the Commissions attention to the need to protect and support the manufacturing processes used to produce enzymes, such as modern biotechnology and fermentation techniques, within the EU. AMFEP consists of 29 members, covering 90% of the European market for enzymes and 80% of the global enzyme market with more than 40 sites across 10 Member States for manufacturing sites and R&D centers. It is critical to enhance manufacturing capacity to ensure that the EU remains a global leader in enzyme production. This could be done supplementing the list of final products and main specific components with the following element: "The manufacturing processes used to produce enzymes, such as modern biotechnology and fermentation techniques.
Read full responseMeeting with Didier Millerot (Head of Unit Financial Stability, Financial Services and Capital Markets Union) and Novonesis A/S and International Flavors & Fragrances
9 Jan 2025 · Sustainable Finance framework, taxonomy
Meeting with Hildegard Bentele (Member of the European Parliament)
26 Sept 2024 · Enzymes
4 Apr 2024
AMFEP, the representative association of manufacturers and formulators of enzyme products, welcomes the Commissions ambition to remove legislative obstacles for the re-use of data and better streamline the flow of chemical data between EU and national authorities, in line with the objectives of the Chemicals Strategy for Sustainability. AMFEP would like to highlight some key issues identified in the proposal as laid out in the following considerations. Firstly, the co-legislators should set a clear and balanced scope for chemicals data disclosure through the platform, with appropriate confidentiality rules To this end, Article 16 and Article 5(2) should be amended to clarify that exposure scenarios leading to the precise use, function or application of a substance should not be made publicly available in the common data platform. Article 16 should also include a confidentiality claim mechanism for business operators. Secondly, the co-legislators should protect REACH registrants from the high administrative and financial costs that accrued to business operators from the food sector following the entry into application of the study notification obligation under Article 32 the General Food Law, in 2019. To promote a cost-effective study notification scheme, the scope of Article 22 should be limited to toxicological and ecotoxicological studies which are performed according to the Good Laboratory Practice Directive (2004/EC/10). Studies under Article 40, 41 and 46 of REACH should be excluded from the study notification obligation because they are carried out in response to requests from the authority.
Read full responseResponse to Streamlining EU scientific and technical work on chemicals through the EU agencies
3 Apr 2024
Many of the substances placed on the market by AMFEP members serve both food/feed and technical applications, thus falling under legislations (e.g. REACH, CLP, the Food Enzymes Regulation) positioned across food and chemicals regimes, therefore potentially subject to assessments conducted by both the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) separately. Thus, AMFEP has a particular interest in the proposed revision of Art. 23 and 30 of the GFL. Firstly, While harmonization of working methods across different EU agencies should be encouraged to increase the quality of risk assessments, the provisions of Article 30 regarding prospective or established diverging scientific opinions should remain at general level: the Commission and the EU agencies can at a later stage define the relevant procedures in detailed guidelines, which should be kept up to date. Secondly, EFSA's duty to cooperate with ECHA on the provision of relevant scientific opinions under the revised Article 23 of the GFL should be applied in a way that doesn't disregard the differences between the assessment priorities of each legislation (e.g. toxicity by inhalation may or may not be relevant endpoint) and the differences in how substances are identified and grouped across legislations (e.g. production strain vs catalytic activity). Indeed, ECHA and EFSA assess enzymes in different manners. Risk assessments under REACH should consider all exposure routes e.g. inhalation, skin and oral for all endpoints. Conversely, EFSA focuses on oral exposure. In addition, divergences in opinions due to different regulatory requirements between the agencies would cause confusions unless one is familiar with them. Thus linking such information based on a simple chemical identification would not provide any value. The increased pressure to prevent potential divergences in opinions across agencies may lead EFSA and ECHA to find themselves in a situation where one entity is waiting for another's conclusions before delivering its own, delaying the timeframe for placing the substances under assessment on the market. This would be particularly unwelcome at a time when assessments are already protracted, resulting in delays that could affect the competitiveness of EU industries. When considering possible harmonisation of working methods across EFSA & ECHA, proper account should be taken of the differences in the way the same enzyme may be registered in food (or feed) legislations on the one hand and the REACH and CLP Regulation Regulations on the other hand. In some cases, a group of substances can be registered under one registration, while each individual substance must be registered separately under other legislations. Too big a pressure to harmonise assessments across regulatory regimes may cause a negative agency conclusion on a substance by a specific applicant in a particular regulatory scheme to affect evaluation in other regulatory schemes, if data and risk evaluations in various schemes are linked with simple identifiers like chemical name and CAS number. Differences in the way the same substances are identified across legislations may increase the risk of false divergences being established according to the proposed revised Art. 30 of the GFL. The application of the new paragraph (m) of Art. 23 should also be discrete enough to reflect such specificities. Overall, ECHA and EFSA conduct distinct risk assessments, each tailored to the specific goals of their respective legislation, with different endpoints of concern. The increased collaboration between authorities should be shaped in a way that doesn't lead to the harmonization of methods and assessments as well as to the application of risk assessments beyond their intended scope, and without considering the context of the substances registration and the objectives of the underlying legislation.
Read full responseResponse to Revision of EU rules on textile labelling
30 Sept 2023
AMFEP, the Association of Manufacturers and Formulators of Enzyme Products, supports the Commissions initiative to help consumers make sustainable choices. However, we warn against the inclusion of additional labelling domains linked with the organicity/ being of bio-origin, a property not linked with sustainability and likely to cause confusion with consumers. Enzymes produced with modern biotechnological methods offer a sustainable solution in textile production. The sustainable contribution of the use of enzymes to the manufacture of textiles is recognised in the Best Available Technology (BAT)1 Reference Document for the Textile Industry2 under the Industrial Emissions Directive. The use of enzymes allows savings in water, greenhouse gas (GHG) emissions, time, and energy. It also reduces the usage of chemical pollutants, thus improving workers safety as well as water quality meeting the ambitious climate goals like the commitment to achieve net-zero emissions by 2050 (UN COP 26 climate summit), achieving a 45% reduction in GHG emissions by 2030 (Paris Agreement), or other targets under the EU Green Deal. The GMMs (Genetically Modified Microorganisms) produced with state-of-art biotechnological methods are used to manufacture high quality enzyme products that are safe for both the users and environment. Using GMMs also allows high yields of enzymes from manufacturing process which reduces production costs, allowing green technologies to compete with cheaper alternatives. They meet the criteria for Safe Strain Lineage which refers to a cluster of related strains that have all been derived by genetic modification from a single isolate (parental strain) that was thoroughly characterised and shown to be non-toxic and non-pathogenic before the modifications to improve enzyme function were initiated. However, textile manufactured with the GMMs cannot be certified as organic because the modern technology used for the GMMs is not accepted even for auxiliary chemicals like enzymes. Establishing an EU-wide labellingdomain on organicity/bio-origin would lead to confusing labelling information to consumers. We strongly propose that the Commission focuses on sustainability elements in the context of ESPR and carefully explores how these elements shall be conveyed to consumers, preferably through electronic information. About AMFEP AMFEP is a non-profit European industry association created in 1977. AMFEP currently has 30 members, representing over 90% of the European and over 80% of the world enzyme market. AMFEP serves as a hub for information exchange and dialogue between enzymes producers and formulators, industry organisations, the scientific community and policy-makers and promotes co-operation on regulatory and safety aspects of enzymes. For further information about AMFEP, please visit our website.
Read full responseResponse to Ecodesign for Sustainable Products - Product priorities
12 May 2023
AMFEP, the Association of Manufacturers and Formulators of Enzyme Products, welcomes the European Commissions consultation on the new product priorities under the upcoming Ecodesign for Sustainable Products Regulation (ESPR). AMFEP members represent 90% of the European enzymes market, accounting for around 80% of the global enzymes market. The preliminary report of the Joint Research Centre (JRC) identifies detergents as one of several product groups for which ecodesign requirements under the ESPR should be introduced. AMFEP would like to echo the JRC reports points on the important role enzymes play in enhancing the sustainability of product groups that will be covered by the ESPR, such as in detergents, where they improve the cleaning performance and enable washing at lower temperatures. Enzymes are biodegradable proteins that act as biological catalysts in various chemical reactions. Per definition, enzymes reduce the use of energy, raw materials and water, as well as the formation of waste. The reactions catalysed by enzymes are specific and often happen under low temperatures and moderate pH levels. As enzymes remain unchanged during reactions, they can continue catalysing reactions at very low concentrations. So even small amounts of enzymes can carry out industrial-scale chemical reactions.Therefore, enzymes reduce energy, chemicals and waste, water and CO2. Enzyme use in detergent formulations significantly contributes to the reduction of energy consumption and CO2 emissions. One of the main innovations enabled by the use of enzymes is the compaction of detergent products. Compaction means that the product is more concentrated and the chemical load on the environment is reduced. Water use is also reduced and there are savings in fuel as less product is transported. For example, the average dosage was reduced by half and the aggregated saving of detergent has been estimated as 30 million tonnes in the period from 1997 and 2017 . AMFEP fully supports the Commissions intention of not duplicating existing chemicals legislation in the ESPR product category measures, unless those have a negative impact on the sustainability aspects of products. We encourage the Commission to use the same approach across Circular Economy legislation.
Read full responseResponse to Initiative on EU taxonomy - environmental objective
3 May 2023
AMFEP, the European Assocition of Manufacturers and Formulators of enzyme products, wishes to draw attention to the place of enzyme-based innovation of plastics from the perspective of Activity CC 1.1 (manufacture of plastic packaging). According to paragraph 3 of Activity CC 1.1, when packaging material is produced, substances meeting the criteria for classification as respiratory sensitisers category 1 in accordance with Regulation (EC) No 1272/2008 should not be added to the feedstock. Bio-based substances such as enzymes fall under the hazard classification of respiratory sensitisers, thus their use in the manufacture of plastic packaging would prevent the corresponding activity from being recognised as contributing significantly to the transition to a circular economy according to the draft delegated act. This is in stark contradiction with the positive role enzymes play in the production of different types of plastic packaging, including biodegradable and compostable packaging for sustainable applications listed in point 4 of the same draft Environmental Delegated Act (lightweight plastic carrier bags, tea bags, coffee pads and sticky labels attached to fruit and vegetables). Enzymes are proteins and are readily biodegradable. There have been many innovations with enzymes on various plastics. Enzymes can be feedstock to plastic packaging goods so an enzyme accelerates the degradation of biodegradable and compostable plastics. Enzymes can be used in several other processes enabling a circular economy for plastics. Considering the clear sustainability benefits of the use of enzymes in the manufacturing of plastic packaging goods, the exclusion based on hazard properties is not relevant. Enzymes safety in relation to consumer exposure has been demonstrated in studies that show sensitisation to enzymes is not an issue for the general or for the most susceptible part of a population. Furthermore, the industry has improved enzyme products to suppress exposure through product design, such as low-volatile liquid formulation and low-dust enzyme granulate, which reduce exposure to a controlled level. General as well as industry specific guidelines are publicly available from the websites of various trade associations as well as from the website of ECHA where all available guidelines can be found via the link to AMFEP. Additionally, a Derived Minimal Exposure Level (DMEL) was established covering all industrial enzymes: Defining occupational and consumer exposure limits for enzyme protein respiratory allergens under REACH - ScienceDirect . This DMEL is based on 40 years of exposure and medical surveillance in the enzyme producing as well as the enzyme handling industries, and it shows that compliance to this DMEL will provide a safe and acceptable working environment for enzyme handling. Remarkably, enzymes are the only respiratory sensitisers which have DMELs. The ability of enzymes to make process designs inherently safer and more sustainable has been already recognized in the EU Ecolabels scheme. While respiratory sensitising substances are banned in several EU, German and Nordic Ecolabels, enzymes are specifically derogated from these requirements in ecolabels for both cleaning products (i.e. detergents and other cleaning products), and textiles due to the safety and benefits which cannot be achieved by other substances. In light of the above, AMFEP strongly encourages the Commission to re-evaluate the exclusion of given substances from the substantial contribution criteria for reasons based solely on hazard classification and that would mistakenly neglect evident, science-based benefits of enzymes deployment in the sustainable plastics value chain.
Read full responseResponse to Streamlining EU scientific and technical work on chemicals through the EU agencies
11 Apr 2022
The Association of Enzyme Manufacturers and Formulators of Enzyme Products (AMFEP) is an EU-based association created in 1977 and consisting of 30 members. Members of AMFEP produce and sell enzyme products for use in food, feed and technical industries. AMFEP member companies produce innovative products destined to a large variety of industries which contribute to sustainability challenges.
Since the start of the commercial production of enzymes, their use in different commercial applications has been continuously growing. Enzymes used for industrial applications are proteins generally existing in nature and are produced by controlled and contained fermentation. They work under mild conditions as they can function at low temperatures and mild pH. In addition, enzymes are only required at low doses to be effective. Enzymes are also readily biodegradable, resulting in no negative environmental impact.
Enzymes therefore actively contribute to the Green Deal objectives incl. the Farm to Fork strategy by improving the efficiency of use of natural resources, reducing energy consumption and reducing waste, in their Food, Feed and Technical uses.
AMFEP focuses on legislation in the area of food and feed safety, occupational safety, registration of substances under REACH and CLP, in relation to enzymes. Such existing legislation is either cross sectorial or very specific to enzymes. Against this background, AMFEP members are used to the current assessment procedures by the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA).
AMFEP is overall satisfied with the way the European agencies deal with our dossiers and evaluate substances. In particular, EFSA and ECHA have gained a lot of experience on enzyme dossier assessment, which led to a rather smooth process.
AMFEP has not noted any particular “inconsistencies” as mentioned by the European Commission document on “Chemicals – making best use of EU agencies to streamline scientific assessments”. The requirements in the various legislations applicable to enzymes are complementary, not overlapping. So are the various assessments performed on enzymes by the EU agencies. All aspects of enzyme safety, as substances and in their various uses, are adequately covered by legislations and evaluations, and we do not observe “duplication” or “inconsistent outcomes” in assessments.
Given the above and as far as enzymes are concerned, AMFEP considers that an in-depth reorganization of the assessments across agencies would not streamline processes or reduce costs and timelines. We do not agree with the statement that the initiative will have “no significant economic […] impact”, and call for a real impact assessment to be conducted. We are deeply concerned that on the opposite, the initiative is likely to create more complexity, as well as a transition period which will considerably affect substance evaluation and authorization processes and timelines, as well as applicants’ burden. This burden will come on top of the increased complexity created by the recent implementation of the Transparency Regulation and its requirements related to confidentiality justification and the new IT tools to be used for notification and submission of dossiers to EFSA and the Commission.
All in all we are not opposed to the one substance - one assessment (OSOA) concept per se, but call the Commission to take more time to concretely evaluate the consequences of this very significant initiative together with stakeholders that are involved in the production, placing on the market and use, of regulated substances.
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