Algae related regulation & legislation

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===== Fertiliser product regulation and related topics =====

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:
  - Fertiliser Product Regulation EC 2019/1009 (FPR),
  - Animal By-Products Regulation EC 1069/2009 (ABPR),
  - Plant Protection Product Regulation EC 1107/2009 (PPPR),
  - REACH Regulation, Evaluation, Authorisation and Restriction of Chemicals EC 1907/2006 (REACH),
  - 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 (indirectly) 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.

===== Fertiliser Product Regulation =====

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 [[https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02019R1009-20251230|EURlex]]

==== Key Points ====

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.

==== Regulatory Hierarchy & Implementation ====

**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 [[https://single-market-economy.ec.europa.eu/document/download/5fbae838-7749-4828-a92a-73a0e4e489db_en?filename=FAQs%2011.0_revised%20on%2016%20June%202025.pdf|FAQ document]]

==== Relevance to Algae ====

**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.



===== Animal By-Product Regulation =====

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 [[https://eur-lex.europa.eu/eli/reg/2009/1069/oj|EC 1069/2009]]

==== Key Points ====
  * **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.
    * FIXME **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 [[https://eur-lex.europa.eu/eli/reg/2019/1009|EU 2019/1009]]).
    * **Traceability and record-keeping** obligations for operators handling ABPs.

==== Regulatory Hierarchy & Implementation ====
  * **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**:
    * [[https://eur-lex.europa.eu/eli/reg/2011/142|Commission Regulation (EU) No 142/2011]]: Implements detailed rules for ABPR, including processing standards and derogations.
    * [[https://eur-lex.europa.eu/eli/reg_del/2023/1605|Commission Delegated Regulation (EU) 2023/1605]]: Supplements EC 1069/2009 by determining end points for organic fertilisers and soil improvers, linking to [[https://eur-lex.europa.eu/eli/reg/2019/1009|EU 2019/1009]].

==== Relevance to Algae ====
  * **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.
    * FIXME 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.

===== Plant Protection Products Regulation, PPPR =====

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 [[https://eur-lex.europa.eu/eli/reg/2009/1107/oj|EC 1107/2009]]

==== Key Points ====
  * **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).

==== Regulatory Hierarchy & Implementation ====
  * **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**:
    * [[https://eur-lex.europa.eu/eli/reg_impl/2013/283/oj|Commission Regulation (EU) No 283/2013]]: Sets out data requirements for active substances.
    * [[https://eur-lex.europa.eu/eli/reg_impl/2013/284/oj|Commission Regulation (EU) No 284/2013]]: Sets out data requirements for PPPs.
    * [[https://eur-lex.europa.eu/eli/reg/2011/546/oj|Commission Regulation (EU) No 546/2011]]: Uniform principles for evaluation and authorisation of PPPs.
    * [[https://eur-lex.europa.eu/eli/reg_impl/2011/540/oj|Commission Implementing Regulation (EU) No 540/2011]]: List of approved active substances.

==== Relevance to Algae ====
  * FIXME **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.


===== REACH Regulation (EC) No 1907/2006 (REACH) =====

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [[https://eur-lex.europa.eu/eli/reg/2006/1907/oj|EC 1907/2006]]

==== Key Points ====
  * **Purpose**: Ensures a **high level of protection for human health and the environment** from risks posed by chemicals, while enhancing the **competitiveness and innovation** of the EU chemicals industry.
  * **Main Objectives**:
    * Require **registration** of all chemical substances manufactured or imported in the EU in quantities of **1 tonne or more per year**.
    * Promote the **evaluation** of chemical risks and the **authorisation** of substances of very high concern (SVHCs).
    * Restrict or ban the use of **hazardous substances** where safer alternatives exist.
    * Encourage the **substitution** of hazardous substances with safer alternatives.
    * Increase **transparency** and knowledge about chemical properties and uses.
  * **Notable Clauses**:
    * **Registration**: Manufacturers and importers must register substances with the **European Chemicals Agency (ECHA)** and provide data on their properties, uses, and safe handling (Articles 5–12).
    * **Evaluation**: ECHA and member states evaluate registration dossiers and substances to assess risks (Articles 40–54).
    * **Authorisation**: Substances of very high concern (SVHCs) require authorisation for specific uses (Articles 55–64).
    * **Restriction**: The use of certain hazardous substances can be restricted or banned if risks are unacceptable (Articles 67–73).
    * **Supply chain communication**: Obligations to communicate information on risks and safe use down the supply chain (Articles 31–36).
    * **Animal testing**: Testing on vertebrate animals is permitted only as a **last resort** (Article 25).
    * **Exemptions**: Some substances, such as **polymers** and **substances occurring in nature** (if not chemically modified), are partially or fully exempt from registration (Article 2).

==== Regulatory Hierarchy & Implementation ====
  * **Legal Status**: EU regulation—**directly applicable and compulsory in all member states** (no national transposition required).
  * **Previous Regulation**: Replaced Council Regulation (EEC) No 793/93 and several related directives.
  * **Delegated Acts / Subregulation**:
    * [[https://eur-lex.europa.eu/eli/reg/2008/340/oj|Commission Regulation (EC) No 340/2008]]: Fees and charges payable to ECHA.
    * [[https://eur-lex.europa.eu/eli/reg/2008/440/oj|Commission Regulation (EC) No 440/2008]]: Test methods for REACH compliance.
    * **Annex XVII**: Lists substances subject to **restrictions** (e.g., synthetic polymer microparticles, certain phthalates, heavy metals).
    * **Annex XIV**: Lists substances subject to **authorisation** (SVHCs).

==== Relevance to Algae ====
  * **Inclusion in Scope**: Algae and algal products are **not automatically exempt** from REACH. The regulation applies to **chemical substances** derived from algae if they are manufactured or imported in quantities of **1 tonne or more per year**.
  * **Why It Matters**:
    * **Algal extracts, pigments, oils, and other chemical substances** derived from algae must be **registered** if they meet the tonnage threshold.
    * **Substances of very high concern (SVHCs)** in algal products may require **authorisation** for continued use.
    * **Restrictions** (Annex XVII) may apply to certain algal-derived chemicals (e.g., if they contain restricted heavy metals or synthetic microparticles).
    * **Substitution principle**: Algal-based chemicals may be favoured if they offer **safer alternatives** to hazardous substances.
    * **Supply chain obligations**: Companies using algal chemicals must communicate safety information to downstream users.
  * **Special Clauses**:
    * **Not chemically modified substances**: If algal substances are **not chemically modified** (e.g., whole-cell algae, natural extracts), they may be exempt from registration, but **processing aids or solvents** used in extraction may still be regulated.
    * **Polymers**: Algal polysaccharides (e.g., alginate, agar) are **polymers** and generally exempt from registration, but their **monomers or additives** may require registration.


===== Waste Framefork Directive (WFD) ====

Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives [[https://eur-lex.europa.eu/eli/dir/2008/98/oj|2008/98/EC]]

==== Key Points ====
  * **Purpose**: Establishes measures to **protect the environment and human health** by preventing or reducing the adverse impacts of waste generation and management, and by improving resource efficiency.
  * **Main Objectives**:
    * Introduce a **five-step waste hierarchy** (prevention, preparing for re-use, recycling, other recovery, disposal) to prioritise sustainable waste management (Article 4).
    * Promote **high-quality recycling** and set binding targets for recycling rates (e.g., 55% of municipal waste by 2025, 60% by 2030, 65% by 2035).
    * Require **separate collection** of waste streams (paper, metal, plastic, glass, bio-waste) where technically, environmentally, and economically practicable (Article 11).
    * Encourage **extended producer responsibility (EPR)** schemes to shift financial and operational responsibility for waste management to producers.
    * Support the transition to a **circular economy** by reducing waste generation and improving resource efficiency.
  * **Notable Clauses**:
    * **Definition of waste**: Any substance or object the holder discards, intends to discard, or is required to discard (Article 3).
    * **End-of-waste criteria**: Waste may cease to be waste if it undergoes a recovery operation and meets specific criteria (Article 6).
    * **Waste management plans and prevention programmes**: Member States must establish waste management plans and waste prevention programmes (Articles 28–29).
    * **Hazardous waste**: Special provisions for the management of hazardous waste, including separate collection and treatment (Article 19).
    * **Selective demolition**: Requirements for selective demolition to facilitate re-use and recycling of construction and demolition waste (Article 11).

==== Regulatory Hierarchy & Implementation ====
  * **Legal Status**: EU directive—**requires transposition into national law** by member states.
  * **Previous Directive**: Replaced Directive 2006/12/EC and consolidated previous waste legislation.
  * **Amendments**:
    * **Directive (EU) 2018/851**: Introduced new recycling targets and strengthened provisions for waste prevention and management.
    * **Directive (EU) 2025/1892**: Added binding food waste reduction targets and extended EPR schemes to textiles.
  * **Delegated/Implementing Acts**:
    * Commission decisions and guidelines on **end-of-waste criteria** for specific waste streams.
    * Member States must adopt **national waste management plans** and report progress to the European Commission.

==== Relevance to Algae ====
  * **Inclusion in Scope**:
    * Algal biomass and residues from algal production or processing **may be classified as waste** if discarded or intended for disposal.
    * **Algal biomass produced in bioremediation facilities** (e.g., grown on wastewater, industrial effluents, or contaminated sites) is **subject to waste regulations** if the biomass is **considered a residue** of a waste treatment process.
  * **Why It Matters**:
    * **Circular economy opportunities**: Algal residues can be valorised as **biofertilisers, biostimulants, or feedstock for biogas/bioplastics**, aligning with the waste hierarchy and recycling targets.
    * **End-of-waste status**: Algal-derived products (e.g., compost, biochar, biofuels) may achieve **end-of-waste status** if they meet EU criteria, facilitating their marketability.
    * FIXME **Hazardous waste considerations**: Algal residues from bioremediation (e.g., contaminated with heavy metals, pollutants, or chemicals) may be classified as **hazardous waste**, requiring special handling, treatment, and disposal according to Article 19.
    * FIXME **Bioremediation residues**: Algal biomass grown on wastewater or contaminated materials must be assessed for **contaminant levels** (e.g., heavy metals, organic pollutants). If contaminants exceed safe thresholds, the biomass may be subject to **hazardous waste regulations** and require specific treatment before further use or disposal.
  * **Special Clauses**:
    * **By-product criteria**: Algal residues may be considered **by-products** (not waste) if their further use is certain, they are produced as part of a production process, and they meet legal product standards (Article 5).
    * **Bio-waste**: Algal biomass used for composting or anaerobic digestion falls under **bio-waste** provisions, subject to separate collection and recycling targets.
    * **End-of-waste**: Algal biomass from bioremediation may qualify for **end-of-waste status** if it undergoes a recovery process (e.g., extraction, purification) and complies with relevant EU product standards (Article 6).