Simplification of rules on transmissible spongiform encephalopathy (TSE)

Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements

Update

The European Commission proposes to simplify the rules on transmissible spongiform encephalopathy (TSE), including “mad cow disease” and scrapie. The objective is to reduce regulatory and operational burdens for authorities and operators by allowing the Commission to adapt control measures to the current level of risk in the European Union (EU), and to align them with international standards. It also proposes to consider gelatine and collagen derived from ruminant bones as safe from bovine spongiform encephalopathy (BSE), in line with the latest scientific knowledge.

Impacted Products

Products from ruminants

What is changing?

The European Commission proposes to simplify the procedure to adapt certain provisions of Regulation 999/2001 on transmissible spongiform encephalopathies (TSEs), including bovine spongiform encephalopathy (BSE) (“mad cow disease”) and scrapie (sheep and goats).

The proposal allows for faster amendment of the requirements on:

• approval of rapid tests and alternative tests
• defining the groups of animals to be tested
• the list of specified risk material (SRM) that must be removed and cannot be exported to the EU (Regulation 999/2001, Annex V)
• the date of effective enforcement of the feeding bans to apply to non-EU countries
• the list of commodities safe from BSE/TSE.

It is also proposed to add gelatine and collagen derived from ruminant bones to the safe products list.

Why?

The EU aims to align its TSE requirements with recognised international standards, and to adapt them to the current level of risk of BSE in the EU (the epidemiological situation). It also needs to consider the opinion of the European Food Safety Authority (EFSA 2024) that ruminant collagen and gelatine derived from bones are BSE safe.

Timeline

This proposal will be discussed by the Council of the EU (Member States) and the European Parliament, a process that can take up to 2 years. So its application is possible in the second half of 2027.

What are the major implications for exporting countries?

Producers of gelatin and collagen from ruminant bones, and producers of composite products using such gelatin, will no longer have to comply with BSE requirements. Producers will be able to source the raw material from any country, with no need to provide guarantees on the raw material used as currently required. If the proposal is adopted, the relevant official health certificates will be amended accordingly (see EU official health certificates for exports to the EU – explained).

Ruminant meat production will be simplified, with lower costs for both official controls and operators.

Background

The most known TSE disease is BSE, known as “mad cow disease”. Other TSE diseases monitored are scrapie in small ruminants (sheep and goats), and chronic wasting disease (CWD) in cervids. These diseases spread mainly in the 1990s in the EU, which adopted strict rules – Regulation 999/2001 – to monitor and eradicate them, with measures on:

• monitoring (compulsory tests in all EU countries and annual report)
• development of detection tests
• removing the tissues at risk in ruminants (the SRM list), such as the skull, spinal cord, tonsils
• adopting a feed ban (a ban on feeding ruminants with animal proteins, and a ban on feeding pigs and poultry with proteins from the same species).

Since 2020, monitoring reports (summarised in EFSA 2025) have shown a sharp decrease in BSE cases.

In 2023, the World Organisation for Animal Health adapted its Terrestrial Code (Art. 11.4) on the BSE surveillance scope (bovine populations and their age). In 2024, EFSA considered ruminant collagen and gelatine derived from ruminant bones to be safe from BSE.

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