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Food supplements need to be assessed for safety and for country-by-country regulatory compliance for all EU member states. TRC will perform the product/ingredients safety assessment according to EU Food Law and the US FSMA. Our expert team of toxicologists, chemists and experienced risk assessors will perform the assessments in-house and will monitor relevant changes.
For each client we appoint a dedicated expert who will assess all raw materials, formulas, packaging and products against the EU regulations and member state regulations that apply to food supplements such as in the areas of traceability, food additives, novel food, contaminants, food contact materials, labelling and claims. Particularly for vitamins, minerals, nutrients and additives, specific restrictions may apply at the individual member state level.
The regulations not only require assessment on compliance, but also the identification and management of any potential hazards, for example potential contamination in relation to individual substances, formulations and production.
It is important to realize that once a product has been assessed as compliant and safe, it can be become non-compliant and/or unsafe. Either through developments in the regulatory and scientific domain, and/or by developments initiated by you as a brand owner and your suppliers. For example, the use of specific substances can be further restricted or banned completely at individual member state level. As a brand owner you may decide to switch suppliers, reformulate your product, or adjust your product claims.
Hazards must be prevented, eliminated or reduced to acceptable risk levels. Critical Control Points (CCPs) need to be established and monitored at stages and for activities where food safety hazards may occur. Corrective measures must be in place to mitigate the impact whenever potential hazards occur.
To be confident about the safety and regulatory compliance of your portfolio it is important to include these aspects in the early stages of the product development process (NPD). Already in the early development stage our experts can assess your product formulas and prevent costly rework and delays in later stages.
At every stage in the product life-cycle and at any time a change takes place, the impact on safety and compliance against the regulatory and toxicological data at substance level can be assessed. This way you and our team can be confident at all times.
