Update: culture media and antibodies subject to additional Border Inspection Post controls

Please see below update from Medtech Europe regarding the proposal to include new CN codes in the EU Animal By-products legislation. See also the EC response to the issues posed by MedTech Europe.

Please note that these requirements will also impact shipments from GB to Northern Ireland, as well as shipments from third countries to Northern Ireland, and shipments from GB to the EU.

I understand that finished IVDs are exempted, as long as animal by-products they contain have meet adequate processing requirements.

MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health.

We are writing to follow up on your correspondence with our national association member VDGH (copied below). The European in vitro diagnostic medical devices (IVD) industry is deeply concerned with the proposed inclusion of certain CN codes in Regulation (EU) 2021/632, necessitating border inspection of the products covered under those codes.

We support the technical comments made by VDGH and wish to highlight the following considerations:

1. Antibodies and culture media are critical to the medical in vitro diagnostics sector including our healthcare systems. Such products are in frequent use in medical tests for microbiological or bacterial infections including for example diagnosing the strain of bacteria, detecting which antibiotic will work against drug-resistant tuberculosis, molecular biology research, immunophenotyping, detection of hepatitis and so on. Any blockage to trade in antibodies and culture media which affects several companies, would have an immediate and devastating impact on Europe’s healthcare (both diagnostic tests and healthcare research) especially given the short shelf-life of many diagnostic tests and reagents. Therefore, great care must be taken to avoid blockages.
2. This proposal appears to deviate from what MedTech Europe understands to be the original intent of the Animal By-Products Regulations (to regulate true animal-by products or animal-derived products i.e. singular substances). Cell culture media “containing animal derived products” are combined products with multiple (sometimes hundreds) of other ingredients including water, amino acids, salts, indicators etc., the vast majority of which are not of animal origin, via several production/filtration/mixing. They cannot be considered “ABPs” in their own right. Existing harmonised model health certificates are mostly either written to identify exclusivity of single animal material composition (which would not be relevant for this code) or prescribe specific treatments that are not applicable to maintain the viability of the final product for technical use purposes.
3. The impact of the proposed inclusion includes considerable increase in paperwork and risk of delays:

1. • Hundreds of thousands of products are expected to be impacted without clear and mitigating criteria conditions to render them exempt
   • Additional import requirements and documentation (health certificates, material origin documents, or processing details) to be provided for each batch
   • Border inspection delays for veterinary checks
   • Potential refusal of entry, destruction or return of goods
   • Specific labelling transport and traceability obligations could apply. If so, this would necessitate a massive undertaking to ensure compliance.
   • Increased compliance cost for inspections
   • Additional resources needed, staff training
2. Antibodies and culture media either as components or finished products intended for IVD examination, should not be included in proposed amendments. Either these CN codes should not be included or the Border Inspection Post should be directed only to products which qualify (and are labelled as) as being intended for food and feed. Components or finished products intended for IVD examination are technical products which are not intended for the food and feed chain. Furthermore, the extensive processing to combine for example, antibodies within blood, including quality testing and safe sourcing of the original animal-derived material and quality release testing of the final technical use product should omit any significant perceived biosecurity risk. We ask the European Commission to regulate those sectors where concern has arisen (such as in the food and feed sector) rather than proposing a blanket inclusion which would impact also our sector, which however poses a low risk to the food and feed sector.
3. Should the European Commission nonetheless include our products in scope of the border inspection, it is vital that the following steps be taken with meticulous care to avoid blocking supply of critical materials and commercial products used in the medical diagnostic sector. This is because any deviations in the paperwork which accompanies products subject to Border Inspection Post controls will result in full blockage at Europe’s borders. This means that the European Commission should ensure that there is 100% coherence between certificates and also that sufficient implementation planning and transition time is provided:

1. • All relevant health certificates listed under Regulation (EU) 142/2011 must be amended to enable trade to take place. All scenarios, accounting for the format of components and technical products, should be carefully identified and accounted for to ensure they can unambiguously be covered by an appropriate health certificate, including for materials, unfinished and finished products. This includes:

1. Listing of the CN codes on all relevant certificates (except the Chapter 20 certificate, since it does not contain tariff codes).
2. Checking the scope of existing certificates to ensure that relevant certificates exist with appropriate fields and are usable for importers and manufacturers. For example, some certificates do allow for import of blood – but from one species only rather than import of raw blood which is combined with antibodies from another species. Another example is that manufacturers may use the Chapter 20 certificate to import intermediate products – but raw products and finished products cannot be imported this way and importers cannot use the Chapter 20 certificate at all. 

• Checking and aligning of definitions such as ‘raw blood of animal origin’ which exists on no health certificates today.

1. • An assessment must be carried out whether this amendment would require manufacturers and importers to register their establishments before trade in the impacted materials and products can take place. If establishments must be (re)registered, a lead time of 12 months would need to be provided.
   • Should this amendment go forward: a sufficient transition period of at least 12 months, would need to be provided to ensure that training of border inspection posts is provided, the necessary templates are available and incorporated into corporate procedures.