Supplement regulatory support in Ireland. From notification to batch release.
Food supplement registration in Ireland requires FSAI notification, EFSA-compliant health claims, accurate labelling and QP batch release before any product reaches the market. Our regulatory team handles all of it. Whether you are launching a new supplement in Ireland, adapting a product for the EU market, or maintaining compliance for an existing range, regulatory support is built into every manufacturing contract.
Compliance is not an add-on. It is built in.
Every supplement we manufacture goes through our regulatory team before it reaches the market. FSAI food supplement notification, health claim review, labelling compliance and QP batch release are part of the manufacturing process, not a separate service you source elsewhere.
- 01
FSAI food supplement notification
Every food supplement sold in Ireland must be notified to the Food Safety Authority of Ireland. Our team prepares and submits the FSAI notification for each product, including ingredient declarations, dosage information and intended use. - 02
EFSA health claims compliance
Health claims on supplement labels and marketing must comply with EFSA authorised claims under Regulation (EC) No 1924/2006. We review every claim on your label and marketing materials against the EFSA register to confirm compliance. - 03
QP batch release in Ireland
Qualified Person batch release is required before any supplement batch can be placed on the market in Ireland and the EU. Our QP reviews batch records, test results and manufacturing documentation, then issues formal release for every batch we produce. - 04
Food supplement labelling compliance
Labels must meet EU FIC Regulation requirements: ingredient lists in descending order, allergen declarations, nutrient reference values, batch codes, best-before dates and statutory warnings. Food supplement labelling compliance in Ireland is checked by our team before any label goes to print.
Why Choose Bioreva Sciences?
Our goal is to contribute to the solution by delivering higher quality products to consumers. As a key player in the Healthcare and Dietary Supplement Industry, we serve as Fillers, Packers, Regulatory Services Provider, Manufacturer, and Solution Provider - 01
Accredited
We hold numerous Pharmaceutical, Nutraceuticals, and Healthcare licences, accreditations & marketing authorisation throughout the globe and are always adding to our portfolio. - 02
Experience
Backed by a Group established in 1993 providing pharmaceuticals & healthcare services to various markets across the globe, with Bioreva established in 2019 to provide contract packing & regulatory support to the regulated markets. - 03
Multi-Site
We operate and work along with multiple production, packing, and regulatory sites across the globe. Bioreva operates sales, marketing and distribution offices across 4 continents, whereas our parent group owns and operates 8 pharmaceuticals and healthcare manufacturing units with multiple lines. - 04
Global Regulatory
We maintain regulatory understanding of and presence in South America, Africa, Asia, East & West Africa and Middle East. Our vast team can fulfil your contract packing, outsourcing and regulatory support in shortest lead times.
The regulatory services that our team delivers alongside every manufacturing project. Food supplement registration in Ireland and beyond.
FSAI notification
Preparation and submission of food supplement notifications to the Food Safety Authority of Ireland. Required for every product placed on the Irish market. Our team handles the full submission and any follow-up correspondence with FSAI.Health claim review
Review of all health claims against the EFSA authorised claims register. We confirm which claims are permitted, advise on wording, and flag any claims that require modification or removal before labelling.QP batch release
Formal Qualified Person batch release for every production batch. The QP reviews manufacturing records, in-process controls, finished product testing and certificate of analysis before issuing release. QP batch release in Ireland is included in our manufacturing service.Labelling review
Full review of label artwork against EU and Irish food supplement labelling requirements. We check ingredient declarations, allergen statements, health claims, statutory warnings and formatting requirements before the label goes to print.Why in-house regulatory support matters
No separate regulatory agency needed
Our regulatory team works inside the manufacturing operation, not in a separate consultancy. This means faster turnaround, fewer miscommunications and regulatory review that runs in parallel with production, not after it.
Catch issues before production
Formulation, ingredient and labelling issues are caught during development, not after you have paid for a production run. Supplement regulatory support that prevents costly rework.
Multi-market expertise
Our team handles regulatory requirements for Ireland, the EU, the UK and international markets. If you are selling in multiple countries, we manage the regulatory differences between them.
Ongoing compliance support
Regulations change. Ingredient approvals are updated. Health claim rulings are revised. Our team monitors changes that affect your products and advises on any updates needed to maintain compliance.
Regulatory support for new products
Launching a new supplement? Our regulatory team handles FSAI food supplement notification, EFSA health claim review, labelling compliance and QP batch release as part of the manufacturing project. Food supplement registration in Ireland, handled from formulation through to market release. .Ongoing regulatory support
Already on the market and need help maintaining compliance? We offer ongoing regulatory support for existing product ranges, including periodic label reviews, health claim updates, regulatory change monitoring and annual FSAI notification renewals.
Regulatory Support FAQs
Do I need to notify FSAI before selling a supplement in Ireland?
Yes. Every food supplement placed on the Irish market must be notified to the Food Safety Authority of Ireland. FSAI food supplement notification is a legal requirement, and our team handles the full submission process as part of our manufacturing service.
What health claims can I put on my supplement label?
Only health claims that have been authorised by EFSA under Regulation (EC) No 1924/2006 can appear on supplement labels and marketing materials in the EU and Ireland. Our team reviews every claim against the EFSA register and advises on compliant wording.
What is QP batch release?
Qualified Person batch release is the formal sign-off that a batch of supplements meets all quality and regulatory requirements and can be placed on the market. QP batch release in Ireland is a legal requirement, and our QP issues release for every batch we manufacture.
Can you help with regulatory requirements outside Ireland?
Yes. Our team handles regulatory submissions for Ireland, EU member states, the UK and international markets. Each market has different requirements for ingredient approvals, labelling, health claims and notification procedures. We manage the differences so your product is compliant wherever you sell i
Providing global supply chain, connectivity, storage, packing and transport solutions in the healthcare industries. We are globally licenced and approved.
Our Company
Links
Contact
Unit A4, Gem Park, Athlone Road, Longford, Republic of Ireland Eircode: N39 T8Y7
- © Copyright 2026 by biorevasciences.com