Algae related regulation & legislation

Algae or their derived products may be used in agriculture as biofertilizers, biostimulants, or biopesticides. Algae may also be considered plants and are thus grown on fertilisers and other products primarily intended for use on plants.

We will examine the following legal sources in this section:

1. Fertiliser Product Regulation EC 2019/1009 (FPR),
2. Animal By-Products Regulation EC 1069/2009 (ABPR),
3. Plant Protection Product Regulation EC 1107/2009 (PPPR),
4. REACH Regulation, Evaluation, Authorisation and Restriction of Chemicals EC 1907/2006 (REACH),
5. Waste Framework Directive 2008/98/EC (WFD).

WFD (among others) establishes the basic framework for the circular use of waste resources and defines the concept of End-of-Waste (EoW). As a directive, it has to be transposed to the member-state level, leading to inconsistent local implementation that has already been an obstacle to various bioremediation projects.

FPR is the first (and, so far, the only) EU-level regulation implementing EoW. Algae are a valid Component Material Category (CMC) #2, included among plant materials, but the same clause excludes cyanobacteria. Algae can also enter as substrates for anaerobic digestion, producing CMC #4 and CMC #5. Algae might also be used unchanged as microorganisms directly applied to soil (CMC 7). FPR does not mention algal fertilisers (fertilisers used as nutrients for algal growth), but this option may be inferred from considering algae as plants.

ABPR is (among others) relevant to fertilising products of animal origin, such as manure. Algae can also be grown on ABP, such as pig manure, or on ABP-derived products, such as biogas digestate (from manure and other materials). In both cases, “grown” means that algae may be used in a bioremediating step of such streams.

PPPR is relevant as a frame regulation for (future) use of algae and algal extracts as plant protection products. Such use is emerging and is under research.

REACH is a general framework for all kinds of (bulk) chemicals. It is a general regulation also relevany e.g. for algal biomass or algal extracts.

Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 EU 2019/1009

Purpose: Establishes harmonised rules for the manufacturing, marketing, and use of fertilising products in the EU, ensuring quality, safety, and environmental protection.

Main Objectives: Unify and update rules for fertilising products, including fertilisers, soil amendments, and plant biostimulants. Facilitate intra-EU trade and reduce legal uncertainty by replacing fragmented national regulations. Ensure high standards for human, animal, and plant health, as well as environmental safety.

Notable Clauses:

• CE marking requirement for compliant products, demonstrating conformity with EU standards.
• Mandatory labelling with minimum information (functional category, components, safety precautions, etc.).
• Harmonised limit values for contaminants (e.g., cadmium) to protect health and the environment.
• Conformity assessment procedures for manufacturers, including EU declarations of conformity.

Legal Status: EU regulation—directly applicable and compulsory in all member states (no national transposition required).

Previous Regulation: Replaced Regulation (EC) No 2003/2003.

Delegated Acts / Subregulation:

• Annexes I and II define technical requirements for component materials and product categories.
• Member states may maintain or adopt additional provisions for environmental or health protection, provided they do not conflict with EU 2019/1009.
• there is a very informative FAQ document

Inclusion in Scope: Algal products used as plant biostimulants, soil amendments, or fertilisers are subject to this regulation if placed on the EU market. Specific Mention: Algae are explicitly named as CMC 2 and CMC 4 together with plant material and mushrooms; cyanobacteria is explicitly excluded; algal extracts, biostimulants, and biofertilisers derived from algae are covered as “fertilising products” if they meet the functional criteria in Annex I or II.

Why It Matters:

• Ensures market access for algal-based fertilising products across the EU, provided they comply with safety and labelling requirements.
• Supports the sustainable use of algae in agriculture, aligning with EU goals for the circular economy and reduced chemical inputs.
• CE marking and conformity assessment provide consumer and farmer confidence in algal product quality and safety.

Special Clauses: None specific to algae, but the regulation’s focus on contaminant limits (e.g., cadmium) and environmental safety is particularly relevant for algal products used in organic or sustainable agriculture.

Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 EC 1069/2009

• Purpose: Establishes public and animal health rules for animal by-products (ABPs) and derived products not intended for human consumption, to prevent and minimise risks to public and animal health and protect the safety of the food and feed chain.
• Main Objectives:
  • Classify ABPs into three risk categories (Category 1, 2, and 3) and define approved uses and disposal methods for each.
  • Ensure safe handling, processing, and traceability of ABPs and derived products.
  • Prevent the spread of transmissible spongiform encephalopathies (TSEs) and other zoonotic diseases.
• Notable Clauses:
  • Strict processing standards for ABPs, including rendering, composting, biogas production, and incineration.
  • Derogations for certain low-risk materials (e.g., milk, eggshells, and fish by-products) under specific conditions.
  • End points in the manufacturing chain: ABPs processed into organic fertilisers or soil improvers may be exempt from further ABPR requirements if used as component materials in EU fertilising products (as per EU 2019/1009).
  • Traceability and record-keeping obligations for operators handling ABPs.

• Legal Status: EU regulation—directly applicable and compulsory in all member states (no national transposition required).
• Previous Regulation: Replaced Regulation (EC) No 1774/2002.
• Delegated Acts / Subregulation:
  • Commission Regulation (EU) No 142/2011: Implements detailed rules for ABPR, including processing standards and derogations.
  • Commission Delegated Regulation (EU) 2023/1605: Supplements EC 1069/2009 by determining end points for organic fertilisers and soil improvers, linking to EU 2019/1009.

• Inclusion in Scope: Algae are not directly regulated as animal by-products under EC 1069/2009. However, fish by-products (including those from aquaculture) are covered, which may indirectly affect algal production systems using fish processing waste (e.g., as nutrient sources for algal cultivation).
• Why It Matters:
  • If algae are cultivated using animal-derived nutrients (e.g., fish hydrolysates, manure), the source materials must comply with ABPR rules.
  • Algal products used as fertilisers or soil improvers may benefit from the end point derogation if processed according to EU 2019/1009, exempting them from further ABPR requirements.
  • Ensures safe and legal use of co-products in algal biorefineries, especially when integrating animal by-products into circular economy models.
• Special Clauses: None specific to algae, but the regulation’s traceability and processing standards are critical for any algal value chain using animal-derived inputs.

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC EC 1107/2009

• Purpose: Establishes harmonised rules for the authorisation, placing on the market, use, and control of plant protection products (PPPs) within the EU, ensuring a high level of protection for human and animal health and the environment.
• Main Objectives:
  • Harmonise the rules for approval of active substances, safeners, synergists, and adjuvants used in PPPs.
  • Ensure that only safe and effective PPPs are placed on the market, based on scientific risk assessment.
  • Promote sustainable use of pesticides and reduce risks to health and the environment, in line with Directive 2009/128/EC (Sustainable Use Directive).
  • Facilitate the internal market for PPPs by streamlining authorisation procedures across member states.
• Notable Clauses:
  • Approval of active substances: Active substances must be evaluated and approved at the EU level before they can be used in PPPs (Articles 4–24).
  • Mutual recognition: PPPs authorised in one member state can be recognised in others, provided the agricultural, plant health, and environmental conditions are comparable (Article 40).
  • Low-risk PPPs: Special provisions for the approval and authorisation of low-risk active substances and PPPs, with accelerated procedures (Articles 22, 47).
  • Minor uses: Rules to ensure availability of PPPs for minor uses (e.g., niche crops) to support agricultural diversification (Article 51).
  • Substitution principle: Active substances that are candidates for substitution (due to high risk) must be phased out if safer alternatives are available (Article 24).
  • Labelling and packaging: Mandatory requirements for clear and accurate labelling, including safety instructions and conditions of use (Article 65).

• Legal Status: EU regulation—directly applicable and compulsory in all member states (no national transposition required).
• Previous Regulation: Replaced Council Directives 79/117/EEC and 91/414/EEC.
• Delegated Acts / Subregulation:
  • Commission Regulation (EU) No 283/2013: Sets out data requirements for active substances.
  • Commission Regulation (EU) No 284/2013: Sets out data requirements for PPPs.
  • Commission Regulation (EU) No 546/2011: Uniform principles for evaluation and authorisation of PPPs.
  • Commission Implementing Regulation (EU) No 540/2011: List of approved active substances.

• Inclusion in Scope: Algae and algal products are not directly regulated under EC 1107/2009, as the regulation focuses on chemical and biological plant protection products (e.g., pesticides, herbicides, fungicides).
• Why It Matters:
  • If algal extracts or metabolites are used as active substances in PPPs (e.g., as biopesticides or biostimulants with pesticidal properties), they must comply with the approval and authorisation procedures outlined in EC 1107/2009.
  • Algal-based PPPs must undergo risk assessment for human health, animal health, and environmental safety before being placed on the market.
  • The regulation supports the development of low-risk and biological PPPs, which may include algal-derived products if they meet the criteria for low-risk active substances (Annex II, Point 5).
  • Substitution principle: Algal-based PPPs could be favoured if they offer safer alternatives to conventional chemical pesticides.
• Special Clauses: None specific to algae, but the regulation’s focus on sustainable and low-risk PPPs aligns with the use of algal products in integrated pest management (IPM) and sustainable agriculture.