By Dr Shirley Heron, Ecosyl Products Ltd, Stokesley, North Yorkshire, UK.
A number of agricultural health issues over the past decade have resulted in the European agricultural industry facing huge increases in legislation. Feed additives is one area that is getting a lot of attention, the main focus being on food safety and security. This has led to the creation of the European Food Safety Authority (EFSA), an independent body tasked with risk assessment of food and feed.
Regulation 1831/2003
Regulation 1831/2003 is the key new legislation affecting feed additives which for the first time includes silage additives. All feed additives must now be approved before being allowed on the market which requires the submission of an extensive dossier covering quality, safety and efficacy.
Additives notified to the EU by the end of November 2004 were allowed to remain on the market but a full dossier had to be submitted by 8th November 2010. Of over 2,600 feed additives notified originally only 43% (1116) submitted dossiers in time.
Those not meeting the deadline were placed in Annex II. We are still awaiting the regulation that will formally remove them from the permitted additive register; until then they can still be sold.
Feed Additive Categories
Regulation 1831/2003 identifies four main groups of additive (Technological, Sensory, Nutritional, Zootechnical), sub-divided into a total of 23 individual categories. The Technological group contains additives that affect the characteristics of a feed or forage, including silage additives.
Silage additive dossiers can be submitted for individual active agents (feed additives), eg a single microorganism, mixtures of active agents or even final products as sold. Most companies have chosen the individual actives route as the approved additive can then be used in many final products, offering greater flexibility.
Silage Additives
Silage additives authorised as Technological additives can only make claims relating to improved fermentation, aerobic stability and effluent production. For performance improvement claims a Zootechnical authorisation must be obtained, a process that is even more rigorous and expensive.
Of the 307 silage additives registered originally only 95 have submitted dossiers. The high drop-out rate is not surprising in view of them being largely unregulated until now. Three possible reasons are: 1) the high cost of preparing a dossier - minimum £50,000 estimated for a simple one; 2) some microorganisms and chemicals would find it difficult to get approval on safety grounds so not worth trying; 3) lack of evidence for efficacy claims.
Labelling
The new legislation has a big impact on product labelling. All silage additive labels must conform to the requirements listed in both Regulation 1831/2003 and the new Feed Marketing Regulation 767/2009. Currently, most labels are still not compliant.
Most silage additives as bought will comprise either a single authorised silage additive or a premixture of individually authorised silage additives. Each of these must now be identified specifically on the label, eg for each microorganism a recognised culture collection strain designation must be given as well as the cfu/g product. This allows you to check if it is in the Feed Additives Register. The seller and the user are both legally responsible for ensuring products are fully authorised.
Assessment
Silage additives have been ear-marked by EFSA as high priority because they have never been characterised before and, for inoculants in particular, there may be safety issues, eg relating to antibiotic resistance.
If approval is given, an E number is assigned which must go on the label of all products containing that additive. Additives not authorised must be removed from the market, although there will be a transition period to allow products already on the market to be used.
Consequences
The new legislation is likely to impact silage additives in a number of ways:
There will be fewer truly different additives to choose from and more 'white label' products - identical but sold under different names. More detailed labels should make this more transparent.
Additives will be thoroughly tested before they are commercialised which is good but it could also prevent good ideas being developed due to the higher costs of bringing them to market.
It should prevent unsubstantiated efficacy claims being made, particularly around animal performance. Bearing in mind that animal performance is key to profitability, this should help differentiate the better additives.
Silage additive label requirements
- The product must be labelled 'SILAGE ADDITIVE' or 'PREMIXTURE of Silage Additives', as appropriate
- Detailed composition under the heading 'COMPOSITION'
- A list of feed additives under the heading 'Feed Additives'
- Functional groups of additives must be indicated, eg silage additives, colourants
- Additives must be named as per the Register listing (see Table 3)
- Identification (E) Numbers of additives must be given
- Minimum cfu/g must be stated for microorganisms and activity units/g for enzymes
- Weight per g for other feed additives
- A list of 'Carriers (feed materials)' in descending order by weight, eg yeast product
- Batch number
- Net quantity
- Expiry date expressed as 'Use before {date}' or, if the date of manufacture is indicated, the minimum storage life expressed as 'Use before {no.} months after the date of manufacture'
- Directions for use, any safety recommendations and, where applicable, categories for which the additive is intended
- Name and address of business responsible for labelling
- Suppliers establishment registration or approval no. (Regulation 183/2005)
If you haven't already booked your silage additive yet - give the office a call to discuss ECOSYL. Our sales of Ecosyl have continued to increased tenfold over the last 2 years - surely those customers who choose to use it can't be wrong. We would like you to join our increasing list of very happy and satisfied customers.
If you haven't already booked your silage additive yet - give the office a call to discuss ECOSYL. Our sales of Ecosyl have continued to increased tenfold over the last 2 years - surely those customers who choose to use it can't be wrong. We would like you to join our increasing list of very happy and satisfied customers.