Feed additives in GMP+ FC scheme
15 April 2016
In addition to compound feed, premixtures and feed materials, feed additives are part of a large group of feed products. The EU legislation includes an individual definition for feed additives. The GMP+ Feed Certification scheme has individual requirements for the safe production and trade of feed additives. Companies that produce or trade feed additives in accordance with these GMP+ requirements are given a separate scope on their GMP+ certificate. In this newsletter we will discuss several GMP+ requirements that apply to feed additives. In doing so, we wish to resolve some misunderstandings. In addition, we would like to draw your attention to processing aids. These are products that may be added during the process in small amounts.
What are feed additives?
The standards in the GMP+ FC scheme are based on the EU definition established for feed additives. GMP+ A2 Definitions and Abbreviations states:
Substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more of the functions. The feed additive shall:
a) favorably affect the characteristics of feed,
b) favorably affect the characteristics of animal products,
c) favorably affect the color of ornamental fish and birds,
d) satisfy the nutritional needs of animals,
e) favorably affect the environmental consequences of animal production,
f) favorably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feeding stuffs, or
g) have a coccidiostatic or histomonostatic effect.
Can only the production of EU authorized feed additives ben GMP+ certified?
No. Not only products authorized in the EU as feed additive can be certified under Production of Feed additives. Products that are authorized as feed additives in countries outside of the EU can be certified under it as well. The relevant producer is to guarantee with its Feed Safety Management System the safety of the feed additive, such as an antibiotic, or veterinary medicine such as Flubendazole or virginiamycin or a growth promoter such as Olaquindox.
A GMP+ certificate states that the production of a product meets the GMP+ requirements. That does not mean that the product can be sold on the EU market as feed additive. If the product is not authorized as feed additive in the EU, it cannot be sold as such. For authorized feed additives, please see the EU Register of Feed Additives.
Must the raw materials used in the production of feed additives, also be purchased from certified?
Producers of feed additives are considered to be the first link in the GMP+ chain. The suppliers of the raw materials the feed additive is made of, fall outside of the GMP+ chain and outside of the scope of the GMP+ FC scheme. As such, they do not have to be GMP+ certified. This also applies for the suppliers of the molasses used in the fermentation process for instance or the corn flour that are added to the feed additive in small amounts (in accordance with the EU authorization of the feed additive).
A producer of an feed additive is required to make a sound assessment and selection of suppliers based on HACCP principles and to make sure that all ingredients fall under an entry check system.
This is required in the standard GMP+ B2 Production of feed ingredients. Article 7.1.2 states the following under d):
‘Prior to the purchase of other products (than the above-mentioned feed) or the purchase of services other than those mentioned above, the participant must carry out a hazard analysis based on the HACCP principles. Based on this hazard analysis and the quality assurance provided by the suppliers, the participant must pick a supplier and adjust its entry check accordingly.‘
In this case ‘other products’ are understood to mean ingredients used in the production of the feed additive.
What about processing aids:
(please also see GMP+ A2 Definitions and Abbreviations or EU Regulation 1831).
Examples of this are anti-foam agents, hexane in extraction or products that are required in filtration processes or to improve fermentation processes, nickel as catalyst in the oleo chemical sector.
The purchase of the processing aids i is also covered under the above-mentioned article 7.1.2.d. GMP+ certification is not required. However, these processing aids must be specified (specifications). Please make sure that any legal food/feed safety limits are included in the specification. If these are not defined in legislation, the company must think about this and define and substantiate them. In addition, the purchase of processing aids must be included in the selection of suppliers and they must be included in the system of entry check, sampling and verification. The analysis results must be reliable. For that reasons, there are requirements with regard to the laboratory and the method used. Please see the relevant GMP+ B2 standard.
How do I label an feed additive?
This strongly depends on the market or the country where this feed additive is sold. Please see the local, applicable legislation.
I am producing a product that is not designated as an feed additive in my country, but as a feed material. How should I apply the GMP+ requirements?
The legal classification or definitions of feed (ingredients) differs per country, region or continent. A product may be classified as feed additive in the EU, but as a feed material elsewhere in the world.
A company that makes such a product – regardless of what the legal definition of the product is to be – can find all relevant requirements for assurance of the feed safety in the standard GMP+ B2 Production of feed ingredients.
The GMP+ FC scheme is largely based on the EU legislation. This is reflected in the classification of a product (feed additive or feed material), in the limits, the FSP registration etc.
We advise a company that produces a product that – depending on the continent – is classified as feed additive or feed material to do the following:
- Establish an assurance system, in accordance with GMP+ B2 Production of feed ingredients.
- A useful tool may be GMP+ D1.2 GMP+ Guidance (available for order via the GMP+ web shop), in which the establishment of a feed safety system in accordance with the GMP+ B2 standard is explained step by step.
- Adhere to the strictest limits.
- In case of certification, ask for 2 scopes to be mentioned on respectively the GMP+ certificate and in the GMP+ Company database: ‘Production of Feed material’ and ‘Production of Feed additive’. In addition, use the free section of the GMP+ certificate for additional information that may be of interest to the market or buyers.
- Check with GMP+ International whether publication in the FSP (Feed Support Products) is required., This is only the case of the product is considered to be feed material.
- Label het product in accordance with the applicable legislation on the market.
If you have any additional questions following this newsletter please ask them via firstname.lastname@example.org. We are at your service!