What to keep on file, according to R. 146

11 April 2022. By FACTS in Regulatory & Nutrition

The labelling regulation under DoH (R. 146) requires that all information related to its requirements “shall be kept on record by the manufacturer, importer or seller, and failure to produce the relevant documentation within 2 (two) working days upon request by an inspector or employee of the Department shall constitute an offence”. This sounds quite scary; so what is included, as information that should be kept on file?

R. 146 (the Regulations Relating to the Labelling and Advertising of Foodstuffs (R. 146/2010 as amended)) does not specifically list what must be kept on record. However, there are sections of the regulation that allude to information that should be kept on file, and/or for which proof must be made available on request.

Use this checklist created by our team to ensure you have such documentation:

Country of origin: the origin of each of your ingredients, and whether they are considered ‘main ingredients’, will determine whether ‘product of’ or ‘produced in’ should be used.
Batch identification: a batch numbering system should be implemented so that each batch is easily identifiable and traceable.
Storage instructions: it is the manufacturer’s responsibility to determine the appropriate storage instruction relevant to the nature of the foodstuff, to ensure that any specific quality attributes for which tacit or express claims have been made are retained and preserved.
Endorsements: proof that any endorsements are in line with the regulations.
Uncommon allergens: must be disclosed on request, based on the information contained in the Supplier Ingredient Information File.
Allergen cross-contamination information: if there is a risk for cross-contamination of a common allergen and precautionary labelling is utilised, then the risk, the manner of assessing the risk, and the steps taken to avoid the risk of allergen cross-contamination must be documented.
Nutritional information: proof of the sources of information (testing or calculations, whichever is applicable).
Sampling procedure: a report on how the sampling was conducted must be compiled based on Guideline 5 of R. 146.
Serving size motivation: appropriate, scientific, evidence-based documentation justifying the serving size that was chosen.
Proof of claims: proof of testing for any nutrition- and/or allergen-related claims.