- Food supplements marketed in a EU Member State have to comply with all relevant aspects of EU food legislation and any specific EU Member State national legislation in terms of their composition, manufacture and control.
- Food Supplements are considered as “foodstuffs” under the EU General Food Law Regulation (EC) No 178/2002
- Required to comply with regulations for manufacture and control of foods
- Applies to Manufacturers, Distributors, and companies who have their Food Supplements manufactured under contract
- GMP Certification IS NOT a legal requirement in the EU for Food Supplements
- Only required for Medicinal Products
- Highly recommended – self-Regulated within the industry (Refer to FS Europe Guide)
- Without proper manufacturing controls, difficult to meet EFSA Claim Requirements
- Measured according to ISO Standards in the EU
- Objectives for QA met when processes have been defined which, when followed, yield a product that complies with its specifications and the quality expected, and when the finished product:
- Contains the correct ingredients in the correct proportions
- Has been correctly processed, according to defined procedures
- Is of the purity required
- Is enclosed in its proper container, which
- Bears the correct label (or is otherwise suitable marked or identified) and
- Is stored, distributed and recommendations given for its subsequent handling in accordance with the recommended storage conditions, so that its quality is maintained throughout its designated or expected life
Quality Assurance Covers Below Points:
- Procedures are written in instructional form, in clear and unambiguous language, and are specifically applicable to the facilities provided
- Records are made during manufacture (including packaging), which demonstrate that all the steps required by the defined procedures were in fact taken, and that the quantity and quality produced were those expected
- Records of manufacture and distribution which enable the complete history of a lot to be traced, are retained in a legible and accessible form
- A system is available to withdraw or recall from sale or supply any lot or product, should that become necessary
- The quality assurance procedures of the suppliers of raw and packaging materials should be monitored, preferably with regular audits. A Supplier Quality Assurance procedure should be developed to define the criteria for selection, approval, review and ongoing approval to ensure that purchased products and services meet the organization’s requirements
- There needs to be rapid feedback of information in the form of summaries of quality performance data (accompanied, where appropriate, by advice) to manufacturing personnel, enabling prompt adjustment or corrective action to be taken when necessary; and to the purchasing function in respect of raw material lots
- Customer/consumer complaint samples should be examined, the causes of defects investigated where possible, and appropriate measures advised for corrective action to prevent recurrence
- Due heed should be taken of new developments in EU food legislation, especially those requiring changes in compositional standards and labelling requirements which may necessitate changes to specifications for raw materials or finished products
A continual review of the Quality Assurance systems should be undertaken to ensure that they remain effective. This should be done by self-inspections.
Quality Control can be achieved by :
- The authority and responsibilities of the Production Management (Operations) and the Quality Control Management functions respectively should be clearly defined so that there is no misunderstanding. Where possible, the Quality Control Management should be on a separate reporting structure from the Production Management and be empowered to make independent decisions on the product quality
- Adequate facilities and staff should be available for sampling, inspecting and testing starting materials, packaging materials, intermediate, bulk and finished products, and where appropriate, for determining environmental quality
- Samples of starting materials, packaging materials, intermediate products, bulk products and finished products should only be taken by personnel and using methods approved by the person responsible for Quality Control
- Results of the inspection and testing of materials, and of intermediate, bulk or finished products should be formally assessed against specifications by the person responsible for Quality Control (or a person designated by them) before products are released for sale or supply
- Product assessment should include a review and evaluation of relevant manufacturing (including packaging) documentation
- Sufficient reference samples of starting materials and finished products should be retained (the latter in the final pack for the finished product) to permit future examination if necessary
Food Supplement Ingredients
- Food Supplement Directive only includes restrictions for vitamins and minerals
- National (MS) rules still apply for other ingredients:
- Amino Acids
- Essential Fatty Acids
- Plants/Botanicals
- Extracts/Isolates
- Lack of harmonization creates a complicated regulatory landscape/process
- Applying principle of Mutual Recognition is “legally” available
- In practice, however, MS make this process difficult
- Regulatory assessment and approval is on a case-by-case basis
- Food ingredients that naturally contain a nutrient can be included in a FS
- Ex. Cod Liver Oil – naturally contains Vitamin A
- Should list on product label as “Cod Liver Oil”
- Should be added to the total amount of that nutrient when determining nutrient values and declared amounts
- No additional purity criteria identified for Annex II Substances
- Directive allows for this in the future
- Must still meet purity criteria established for food additives
- Food Supplement Ingredients – Harmonization
- Member state specific requirements for ingredients may include:
- Restrictions or guidelines for additional vitamins/minerals
- Minimum/maximum levels for vitamins/minerals found in the Directive
- Positive/Negative lists for plants and other substances
- Member state specific requirements for ingredients may include:
- Food Supplement Ingredients – Annex I and II
- All vitamins and minerals permitted in Food Supplements are listed in Annex I of the Directive
- All vitamin and mineral sources (substance forms) permitted in Food Supplements are listed in Annex II of the Directive
- What if my product includes a vitamin or mineral not listed in the Annex?
- Not permitted to sell the product in the EU
- Can apply to EFSA for inclusion of a vitamin/mineral source in Annex II
- Administrative guidance document exists to help companies with application process for safety evaluation with EFSA