Animals > Livestock Feeds > Trade Memoranda  

T-3-148 - REGULATORY STATUS OF ENZYME BEARING PRODUCTS

September 1, 1997

Since specialized products designed only to be sources of enzymes in feeds were introduced into the marketplace, the Animal Health and Production Division has clarified the status of these products under the Feeds Regulations. Enzyme sources are currently approved and listed in the Schedule IV of the Feeds Regulations.

Presently, most enzymes added to feeds are in the form of non-viable fermentation by-products. There are three basic fermentation products containing enzyme activity. These are:

As enzyme products used in the feed industry are covered by what is listed in the Feeds Regulations and as, to date, there is no "pure" enzyme product available, there has been no reason to include a description for purified enzymes.

The following policy has been agreed upon after consultation with the stakeholders:

When an ingredient list is shown on any product label, the enzyme bearing ingredient(s) (i.e. fermentation product, as for example Aspergillus niger fermentation solubles, from which the enzyme activity is derived) rather than the enzyme derived (e.g. cellulase) will be listed.

When a product is marketed for its enzyme content, guarantees for the enzyme activity(ies) will have to be made on the label. Such products will be registered as "enzyme supplements". It should be noted that products bearing enzyme guarantees on the label are not exempted from registration, as no nutrient ranges have been set forth for them in Table 4 of the Feeds Regulations (Section 5(2) (iii) and (iv).

Prior to applying for registration at the Feed Section, companies must submit the following information:

• A sample of each enzyme bearing product submitted for registration;
• The product formulation;
• The description of the analytical methods for determination of the enzyme activity (ies) guaranteed (including supporting data). The proposed methods will be reviewed and tested individually, according to the protocol described in the trade memorandum T-3-148 suppl., outlining the Guidelines for the Evaluation of Methods to Determine the Activity of Enzyme Ingredients Used in Animal Feed;
• Certificates of analysis for three different lots of the product showing that, using the analytical methodology(ies) submitted, the product meets the guarantees shown on the labels;

The above required information should be submitted directly to this address:

Laboratory Services Division
Room 230
Building # 22
Central Experimental Farm
960 Carling Avenue
Ottawa, Ontario
K1A 0C6

Once the method has been validated by LSD, companies will then have to apply for registration under the Feeds Act and Regulations at the Feed Section.  To support registration, companies will only be required to submit the standard registration documents (i.e. application form CFIA 0009, application fees, proposed label and accompanying letter).

As always, registration is subject to the submission of acceptable information on the safety and efficacy of the product. In developing the 1996 "Guidelines for the Safety Assessment of Novel Feeds: Microbial Products", the expert advisory committee recognized the potential of microbial products (including fermentation products) to cause dermal and respiratory irritation and/or sensitization. Registrants are therefore required to:

• conduct dermal/respiratory sensitization/irritation studies;
• include the following label statement on all enzyme bearing product labels:
  "This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling."; or
• provide scientific rationale as to why the above are not necessary.

Questions regarding this memorandum may be forwarded to:

Feed Section
Animal Health and Production Division
Canadian Food Inspection Agency
59, Camelot drive
Ottawa, Ontario
K1A 0Y9

tel: 613-225-2342 
fax: 613-228-6614