Blackhead in Turkeys - Questions and Answers
Q1. What is blackhead?
A. Blackhead is a serious condition that can cause high mortality rates in young birds. It is caused by a protozoan parasite. The disease does not affect people.
Q2. How is blackhead treated?
A. No product is currently licensed specifically for the treatment or control of blackhead. Two products, dimetridazole (DMZ) and nifursol were formerly licensed but the use of these substances was banned under Commission Regulation 2205/2001 in May 2002 and 1756/2002 in March 2003.
Q3. Why have DMZ and Nifursol been banned from use in Turkeys?
A. Both substances were subject to review under Directive 70/524. These reviews can be routine, designed to bring product authorisations up to modern standards, or to address a specific concern. Companies consider whether it is economic for them to go to the expense of producing additional data to support the continued authorisation of a substance as a feed additive.
The authorisation for DMZ was withdrawn in May 2002 because insufficient data had been presented by the company during the review.
For Nifursol, the European Commission asked the Scientific Committee for Animal Nutrition (SCAN) to make a new scientific risk assessment. SCAN adopted an opinion that on the basis of mutagenicity, genotoxicity and carcinogenicity studies provided by the manufacturer and because of a lack of data on developmental toxicity, it was not possible to set an Acceptable Daily Intake (ADI). Consequently, it was not possible to provide adequate assurances of the safety of the product to consumers.
Q4. What did the companies who manufactured the products do to try to address the problems?
A. The manufacturer of Nifursol provided additional data that they hoped would satisfy the requirements of SCAN and prevent the withdrawal of the product. However, SCAN identified a number of gaps in these data and concluded that they still could not provide assurances of the safety of the product to consumers. The Commission, therefore, decided to apply the precautionary principle and to withdraw the authorisation.
The manufacturer for DMZ decided not to produce the necessary data.
Q5. What was the UK's position on DMZ and Nifursol?
A. Without the data to support DMZ and with Nifursol available for the prevention of blackhead, the UK supported the proposed ban.
For Nifursol, the UK, along with other Member States, accepted the validity of the concerns that SCAN raised. However, the UK expressed concern at having reached a position where the last available authorised treatment for blackhead was lost for use in turkeys. We emphasised the very serious consequences that this was likely to have for the turkey industry in the UK and across the EU. The UK also gained a six-month grace period between the date the Regulation banning the product was published and implementation of the ban.
Q6. What is being done to address the problem of there not being an authorised treatment for blackhead in turkeys?
A. The UK, as rapporteur for Nifursol, wrote to the company to advise them that should they wish to have Nifursol re-authorised they will have to make a new application and provide the necessary data. Ultimately, this is a commercial decision for the company. To date no application has been received.
Meanwhile, the UK is encouraging the Commission to review the balance between banning products that present a hypothetical risk to human health and at the same time creating known animal health and welfare problems by the lack of availability of suitable treatments for serious conditions.
The Commission has accepted an application under Regulation (EC) No.
1831/2003, Article 15 for an urgent authorisation. This is currently
going through the assessment process.
Reviewed: 1 February
2006
Page published:
August 28, 2008