This page provides information about the role of end points, especially their connection to:
- alternative methods
- fertilisers, pet food, biofuels, textiles, cosmetics, and pharmaceuticals.
It also guides stakeholders on the procedures for proposing alternative methods to be assessed by the European Food Safety Authority (EFSA).
What Are End Points?
An end point in the manufacturing chain of animal by-products is the stage where a derived product no longer poses any significant risk to public or animal health, as:
- The product is no longer subject to ABP regulations, and can be traded without animal health restrictions in the EU
- It becomes governed by other EU legislation relevant to its final use, such as for fertilisers, pet food, biofuels, textile, cosmetics, or medical devices.
Key Legislation Related to End Points:
- Regulation (EC) No 1069/2009, Article 5(2): End points may be determined for safe derived products intended for specific end uses, following EFSA’s risk assessment on animal and public health risk, in accordance with Article 29 of Regulation (EC) 178/2002. An end point may be determined only by the Commission Delegated Regulation
- Regulation (EC) No 1069/2009, Article 20: Provides the procedure for the risk assessment of a new alternative method for the production of new derived products (e.g., intended for the EU fertilising products)
- Regulation (EU) No 142/2011, Article 3: Lists certain end points for uses outside the feed chain and fertilisers
- Regulation (EU) No 142/2011, Annex VII: Provides formats for applying for the authorisation of alternative methods or disposal of ABPs
- Commission Delegated Regulation (EU) 2023/1605: Specifies conditions under which derived products intended for fertilisers can reach an end point.
The Role of End Points in Animal By-Products Regulation
- Ensure safe transition of derived products to sectors like fertilisers, pharmaceuticals, pet food, textile, cosmetics, and energy
- Support innovation by allowing flexibility for alternative processing methods
- Promote sustainability by encouraging the reuse of ABPs in various industries.
End Points and Their Impact on Different Sectors
1. Fertilisers and Soil Improvers
- Fertilisers derived from animal by-products play a crucial role in sustainable agriculture and the circular economy. Products such as compost, organic fertilisers, and processed manure can reach an end point once they meet strict safety and processing standards, after which they are regulated under Regulation (EU) 2019/1009 (Fertilising Products Regulation).
- Relevant Regulation: Commission Delegated Regulation (EU) 2023/1605 aligns with the requirements for EU fertilising products as outlined in Regulation (EU) 2019/1009.
- Delegated Regulation (EU) 2023/1605 always refers to a processing method set out in Regulation (EU) No 142/2011, either to the standard or alternative processing method.
- Safe Use: Fertilisers must undergo approved processing methods (e.g., composting or anaerobic digestion) to ensure they no longer pose risks to health or the environment.
- Determination of an end point for derived products intended for EU fertilising products is possible
- after an application for an EFSA assessment validated by the national competent authority and
- listing of a new alternative method into Regulation (EU) No 142/2011.
2. Pharmaceuticals
Certain animal-derived pharmaceuticals can reach an end point if they meet safety standards for medicinal use. Example: heparin, extracted from pig intestines, is widely used as a blood thinner and is regulated under pharmaceutical laws rather than ABP rules.
3. Biofuels
Rendered fats and animal-derived oils used for biodiesel production may be granted an end point, making them subject to renewable energy regulations. Example: biodiesel derived from Category 3 animal fats can be sold and used as fuel under EU Renewable Energy Directive rules.
4. Cosmetics and Medical Devices
Ingredients such as lanolin (from wool grease) used in skincare products can be considered safe and regulated under cosmetic legislation. Example: medical-grade collagen extracted from animal tissues may reach an end point and be regulated under medical device legislation.
5. Pet Food and Animal Feed
In certain cases, processed animal proteins (PAPs) and other ABP-derived feed ingredients can reach an end point, allowing them to be used in pet food or livestock feed. Example: fish oil refined to a high standard may exit ABP controls and be regulated under animal nutrition laws.
Applying for end points
Operators interested in applying for end points or introducing new alternative methods for processing ABPs must follow these steps, in application of Article 20 of Regulation (EC) No 1069/2009:
1. Consult their national competent authority for guidance.
2. Application Preparation:
- Applications must comply with the formats outlined in Regulation (EU) No 142/2011, Annex VII. The standard format for the application for authorisation of alternative methods can be found in Article 16 of, and Annex VII to, Regulation (EU) No 142/2011
- EFSA instructions
- Work closely with your national competent authority to ensure all required documentation, analyses, and tests are prepared
- The application should be evaluated by that competent authority.
3. EFSA Risk Assessment:
- That competent authority is to submit the application for EFSA’s assessment, together with a report on its evaluation and inform the Commission. EFSA will assess the public and animal health risks associated with the proposed method or derived product.
4. Incorporation into Legislation:
- Following a positive EFSA assessment, the method or product may be included in Regulation (EU) No 142/2011 via amendment.
Key Resources:
Additional Information and Links
- The Animal By-Products legislation provides for the necessary flexibility for introduction of a new alternative processing methods, and provides for end points in the manufacturing chain
- EU legislation and EFSA guidance documents detail how to compile dossiers for submission and the information and studies required for the evaluation. EFSA’s guidance is updated regularly so applicants should check they are using the latest version before applying
- Operators who wish to use alternative methods or propose for an end point, should
- Follow the procedure referred to in the rules explained above
- Always work in close cooperation with the relevant competent authority which will lead and advise in discussion with EFSA, and represent you in discussion(s) with the Commission.
- External links:
Contact Us
For further inquiries, please contact:
European Commission - Animal By-Products Team
This webpage is regularly updated to reflect changes in EU regulations and best practices.