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State of feed additives in new legal environment

Regulation (EC) no. 1831/2003 concerning additives for feed stipulated that all feed additives had to be reassessed by 8 November 2010. A short time after that, the Commission made a distinction in the Online European Feed Additive Database.

The first part of the Feed Additives Database (Appendix 4, Annex 1) includes all feed additives which were admitted between 2003 and 8 November 2010 and the feed additives for which a file had been received for reassessment on 8 November 2010.
 
The second part (Annex 2) lists all feed additives for which no file for reassessment had been received by 8 November.
 
This latter group of feed additives will be prohibited within a foreseeable period of time. It is not clear yet whether a so-called withdrawal will be issued.
 
At any rate, there will be regulations about selling out periods and the Commission will explore measures to prevent these prohibited additives from reaching the market as feed material.
 
Grey list
Within this context also the work of the Commission on the "grey list products" has been of relevance.
 
"Grey list” products are products which on the one hand consist of feed additives which are also used as feed (double listing) and on the other hand of products about which there has been a great deal of discussion in recent years whether they are feed additives, feed materials or even veterinary medical products.
 
This discussion was completed in October with the publication of Regulation(EU) no. 892/2010.
 
This regulation includes two lists: one with former additives which from now on are considered as feed materials, and a second list with products which had not been categorised before.
 
The products on both lists can be considered as feed materials. In order to avoid future discussions as much as possible, the Commission approved a recommendation in November in which guidelines are included for the distinction between feed additives, feed materials and other products which can be used in feed.
 
These guidelines must be followed in the assessment of "new" or "not-categorised" products. The Recommendation by the Commission will be published before long.
 
Consequences within the GMP+  FSA scheme

Product
New status
GMP+ consequences
A. Feed additive for which no re-authorisation file has been submitted.
Prohibited
This product can no longer be sold under the GMP+ certificate (the selling out period will be taken into account)
B. Product in the "Grey list"*): List 1: former feed additives and
List 2: products without categorisation
Feed materials
This product is admissible under the GMP+ certificate.
C. Former premixes
Compound feeds
This product is admissible under the GMP+ certificate.
*) A new version of the Catalogue will be published before long in which the products of List 1 and List 2 are included
 
A number of GMP+ certified companies will be confronted with the modified legal status of their products (as described above).
 
Consequences for companies
Companies which are confronted with this situation will have to reckon with the following changes:
Producers of the products referred to above now produce feed materials and/or compound feeds rather than feed additives and/or premixes.
 
For feed materials and compound feeds other standards and monitoring conditions apply in a number of cases.
 
Purchasing changes
Not only the GMP+ certified producers of these products will be faced with changes, this also goes for GMP+ certified companies which purchase these products.
 
The GMP+ FSA scheme includes different conditions for the purchase of feed additives than for the purchase of feed materials.
 
An important difference is that feed additives can also be purchased via the so-called Gatekeeper option and that feed materials can not.
 
When GMP+ certified companies (traders, processors) purchase the products referred to above, they must taken into account this difference.
 
A transitional period has been determined for the compliance with these conditions as well.
 
FAMI-QS qualification
A special item deserving attention is the purchase of former feed additives (from List 1) from FAMI-QS certified companies.
 
At this moment it is being examined to what extent acceptance of FAMI-QS certified companies can continue to apply for these products.
 
The current acceptance will continue to apply until there is more certainty about this.
 
Feed Safety Database (FSD)
Within the GMP+ FSA scheme it is required that a risk assessment is included in the FSD for each type of feed material to be purchased or received.
 
This obligation also applies for the new feed materials which are included in the Catalogue of Feed Materials.
 
An application for inclusion of a risk assessment can be filed by means of the model available for that purpose. More information about this model and the acceptance procedure can be found on the GMP+-website.
 
The above also goes for the products which were covered by the legislation relating to ‘special nitrogenous substances' and which are now included in the Catalogue of Feed Materials. These products were already included in the Catalogue of 19 March 2010 (Regulation (EU) 242/2010).
 
A transitional period has been determined for the compliance with these conditions as well.
 
Transitional period
The IEC (GMP+ International Expert Committee) has decided to create a transitional regulation for these new feed materials.
 
For these products a transitional period of 3 years applies as of the official inclusion of these products in the Catalogue of Feed Materials as published by the European Commission.
 
This transitional period thus matches the transitional period determined by Brussels and gives all participants and the certification bodies concerned an opportunity to realise GMP+ FSA scheme changes carefully and timely.
 
To participate in this transitional scheme, GMP+ certified producers of / traders in these new feed materials must register themselves with GMP+ International for the purpose of publication of a risk analysis in the FSD database.
 
This registration must take place within 3 months after publication of the new Catalogue.
 
More info can be obtained by email from GMP+
 
 

Dick Ziggers

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