If you sell into both the EU and US, your food safety system should be built once and meet both sets of requirements. This package combines FDA FSMA and EU food law compliance into a single coordinated programme.
Food producers exporting between the EU and US face two separate regulatory frameworks: FDA FSMA in the United States, and the EU Hygiene Package, principally Regulation 852/2004, in Europe. Treated as separate projects, this means two gap assessments, two food safety plans, and two sets of training.
This package takes a different approach. We start with a single dual-market gap analysis covering both frameworks at once, then build one underlying food safety management system based on a hazard analysis that satisfies both HARPC under FSMA and HACCP-based requirements under EU food law. Market-specific additions, such as FSMA 204 traceability or EU food safety culture, are then layered on top of that shared foundation.
The result is a single set of documentation, a single set of records, and a single internal team that understands both frameworks, not two parallel systems that drift apart over time as each is updated independently.
This is Confi Food's most requested consulting package, reflecting how common dual-market trade has become for food producers of every size, from small specialty exporters to established manufacturers expanding into a second market for the first time.
FSMA and EU food law overlap significantly, but each market also has requirements the other does not. The package addresses both sides explicitly.
HARPC and HACCP share the same preliminary steps: assembling a food safety team, describing the product, identifying intended use, constructing a process flow diagram, and confirming it on-site. Both then apply a preventive, hazard-based approach with monitoring, corrective action and verification. Allergen cross-contact is an explicit requirement in both frameworks, just under different regulatory references. Building the hazard analysis once, to the slightly broader US standard which includes economically motivated adulteration, generally satisfies both frameworks' core requirements, leaving only the market-specific additions to be layered on separately.
This package is built for businesses operating across, or expanding into, both the EU and US markets.
European food producers seeking to register a facility for US export and meet FSMA's Preventive Controls requirements for the first time, while maintaining existing EU compliance.
US-based producers supplying European customers and needing to meet EU Hygiene Package requirements, including the food safety culture obligations under Regulation 2021/382, alongside their existing FSMA compliance.
Producers in other countries exporting to both the EU and US, who need a single system that satisfies both sets of import-country requirements instead of maintaining parallel compliance programmes.
Companies already compliant in one market and now expanding into the other, who want their existing food safety system extended efficiently and not rebuilt from scratch.
Facilities producing for brand owners who sell into both the EU and US, where the facility itself needs to demonstrate compliance with both frameworks independently of the brand owner's own certifications.
Companies that, in addition to baseline regulatory compliance in both markets, need or want GFSI-recognised certification such as FSSC 22000 or BRCGS, which both EU and US retail buyers increasingly require.
The EU-US Export Compliance Package is fixed scope, with clear deliverables for each stage. The components below cover the full programme.
A single gap analysis covering both FDA FSMA's 21 CFR Part 117 and the EU Hygiene Package, identifying shared requirements, market-specific gaps, and any conflicts requiring adjustment between the two frameworks.
Guidance on FDA facility registration under section 415 of the FD&C Act for EU producers exporting to the US, and confirmation of exemption status where applicable.
A single hazard analysis and food safety plan built to satisfy both HARPC under FSMA and HACCP-based requirements under EU food law, covering biological, chemical, physical, allergen and economically motivated hazards.
For businesses handling foods on the FDA's Food Traceability List, planning for Key Data Element and Critical Tracking Event recordkeeping ahead of the July 2028 deadline.
Implementation of the five mandatory pillars under Regulation 2021/382: communication, leadership commitment, staff awareness, supportive environment, and continuous review, with a framework for generating observable evidence.
Allergen management addressing both the 14 EU and UK allergens under Regulation 1169/2011 and the 9 US allergens under FALCPA, with cross-contact controls satisfying both Regulation 2021/382 and modernised CGMP requirements.
Training covering PCQI-aligned competencies for the US side and food safety culture awareness for the EU side, delivered as a single coordinated programme and not two separate courses.
A mock FDA inspection structured around 21 CFR Part 117, and a mock EU or UK competent authority inspection structured around Regulation 852/2004 and food safety culture, both conducted against the same underlying documentation.
Support drafting responses to findings from either an FDA inspection or an EU or UK competent authority inspection, including corrective action plans that update the shared documentation for both markets.
Like all Confi Food consulting packages, the EU-US Export Compliance Package is fully productized: fixed scope, clear deliverables, defined timelines. No open-ended retainers, no scope creep. You receive a written proposal covering every component above before work begins.
The package follows a defined sequence, building the shared foundation first and then layering on market-specific requirements. Our part of the process typically takes 4 to 6 weeks.
| Stage | What happens | Our role | Duration |
|---|---|---|---|
| 1. Dual-market gap analysis | Your current food safety system is reviewed against both 21 CFR Part 117 and the EU Hygiene Package, identifying shared, market-specific and conflicting requirements. | We conduct the analysis and deliver a single written action plan covering both markets. | 3 to 5 days |
| 2. Registration and exemption review | FDA facility registration status is confirmed for US export, and exemption status under both frameworks is established. | We review registration status and confirm exemptions for both markets. | 2 to 3 days |
| 3. Team and process mapping | The food safety team is assembled. Process flow diagrams are constructed and confirmed, serving as the foundation for both frameworks. | We facilitate team setup and construct the process flow diagrams. | 2 to 3 days |
| 4. Unified hazard analysis | A single hazard analysis covering biological, chemical, physical, allergen and economically motivated hazards, built to the broader US standard so it satisfies both frameworks. | We facilitate the hazard analysis workshop and document the outputs. | 3 to 5 days |
| 5. Preventive controls and CCP determination | Preventive controls and critical control points are determined, with monitoring, corrective action and verification documented to satisfy both HARPC and HACCP requirements. | We determine and document controls under PCQI-aligned oversight. | 3 to 5 days |
| 6. Market-specific additions | FSMA 204 traceability planning and EU food safety culture framework are developed and layered onto the shared foundation. | We design both market-specific additions in parallel. | 1 to 2 weeks |
| 7. Documentation | The complete unified food safety management system is documented, covering both frameworks with market-specific sections clearly flagged. | We write the full documentation in collaboration with your team. | 1 to 2 weeks |
| 8. Training and mock inspections | Staff are trained on the unified system. Mock inspections for both FDA and EU/UK authority assessment are conducted. | We deliver training and conduct both mock inspections, issuing findings reports. | 3 to 5 days |
| 9. Ongoing support | Regulatory monitoring for both jurisdictions, since FSMA, EU law and UK assimilated law can each change independently. | We provide a retainer covering both frameworks' regulatory updates. | Ongoing |
The package begins with a single gap analysis that maps your current system against both frameworks at once, instead of running two separate assessments that produce two separate action plans.
The dual-market gap analysis reviews your food safety system against FDA FSMA's Preventive Controls for Human Food rule under 21 CFR Part 117 and the EU Hygiene Package, principally Regulation 852/2004, alongside Regulation 2021/382 and Regulation 1169/2011.
The output structures findings into three categories: requirements shared between both frameworks, where one piece of work satisfies both. Requirements unique to one market, which need market-specific attention. Any conflicts, where a practice acceptable in one jurisdiction needs adjustment for the other.
We confirm FDA registration status and exemption status under both frameworks before any documentation review begins.
We review existing food safety plans, HACCP documentation and records against 21 CFR Part 117 and the EU Hygiene Package side by side.
We assess the physical operation against documented procedures, including allergen handling relevant to both the 14-allergen and 9-allergen frameworks.
We produce a single gap analysis report structured around shared, market-specific and conflicting requirements, with a prioritised action plan.
If you already have a HACCP or HARPC plan for one market, the gap analysis identifies exactly what needs to be added for the other, instead of starting again.
When EU and US compliance are handled as two unrelated projects, the same issues come up repeatedly.
A HARPC plan and a HACCP plan built independently, by different consultants or at different times, inevitably diverge as each is updated for its own market. A process change made for FSMA compliance may never be reflected in the EU documentation, and vice versa, creating two systems that no longer describe the same operation.
Because HARPC and HACCP share the same preliminary steps and preventive approach, running separate hazard analyses for each market duplicates a large amount of work that could be done once, to the broader of the two standards, and then adapted.
The 14 EU and UK allergens and the 9 US allergens overlap but are not identical. Labels designed for one market without considering the other often need a complete redesign and not a simple addition when expanding into the second market.
When two separate consultants or teams handle each market, internal staff often end up with two disconnected sets of knowledge, neither of which gives a complete picture of what the business needs to do, or why a requirement exists in one market and not the other.
EU producers sometimes build out a full FSMA-aligned food safety plan before realising the facility itself was never registered with the FDA, which is a prerequisite for the Preventive Controls requirements to even apply in the intended way. Registration status should be confirmed at the start, not discovered partway through.
Consultants focused primarily on FSMA compliance often have limited familiarity with Regulation 2021/382's food safety culture requirements, which are assessed very differently, through observation and interview and not documentation. This gap is invisible until an EU or UK inspection occurs.
If you only trade in one market, our standard single-market consulting may be the better fit. The comparison below helps clarify which applies to you.
| EU-US Export Compliance Package | FDA FSMA consulting only | EU food law consulting only | |
|---|---|---|---|
| Best for | Businesses trading in or expanding into both markets | Businesses trading only in the US market | Businesses trading only in the EU or UK market |
| Gap analysis | Single dual-market analysis | 21 CFR Part 117 only | EU Hygiene Package only |
| Food safety plan | One unified plan covering both frameworks | HARPC food safety plan | HACCP-based food safety plan |
| Our consulting | EU-US Export Compliance Package | FDA FSMA | EU food law |
What drives the timeline and cost of the EU-US Export Compliance Package. As with all our packages, you receive a written proposal with a fixed fee after the initial consultation.
Timeline
How long our consulting work takes
Cost factors
What drives the consulting fee
No existing food safety plan for either market. Our consulting work typically takes 4 to 6 weeks, building the unified system and both market-specific additions.
An existing HACCP or HARPC plan for one market can be extended for the other. Our consulting work typically takes 2 to 3 weeks, focused on the gap analysis and market-specific additions.
A single product line requires a smaller unified hazard analysis than a multi-product facility with several distinct process flows across both markets.
If your products are on the Food Traceability List, traceability planning adds to the scope. If not, this component is scoped out entirely.
EU facilities not yet registered with the FDA require registration guidance as part of the initial stages, which is scoped separately from the food safety system work.
Products containing allergens that differ between the 14-allergen and 9-allergen frameworks, such as sesame, celery or mustard, require more detailed dual-market labelling work.
Where the package is combined with FSSC 22000, BRCGS or another GFSI scheme, certification-specific work is scoped as an extension once the dual-market foundation is in place.
An optional retainer covers regulatory updates for both FSMA and EU/UK food law, since each can change independently and on different timelines.
Answers to the questions we hear most often from businesses trading between the EU and US.
The EU-US Export Compliance Package is a coordinated consulting programme for food producers exporting between the EU and US markets. Instead of running two separate compliance projects, one for FDA FSMA and one for EU food law, the package combines both into a single gap analysis, a single food safety management system designed to satisfy both frameworks, and coordinated audit preparation for both jurisdictions. It is Confi Food's most requested consulting package.
FSMA's HARPC food safety plan and the HACCP-based food safety plan required under EU Regulation 852/2004 share the same preliminary steps, the same preventive, hazard-based approach, and significant overlap in hazard analysis, monitoring and verification. Running these as two separate projects duplicates a large amount of work. A combined approach builds one underlying food safety management system, then layers on the specific additional requirements each market imposes, such as FSMA 204 traceability for the US or food safety culture under Regulation 2021/382 for the EU.
The package is designed for food producers and manufacturers who currently export to, or plan to export to, both the EU and US markets, or who are evaluating expansion into one market while already supplying the other. This includes EU-based manufacturers seeking to register facilities for US export, US-based manufacturers seeking to meet EU hygiene requirements for European customers, and businesses in third countries exporting to both regions.
The dual-market gap analysis reviews your food safety system against both FDA FSMA's Preventive Controls for Human Food rule under 21 CFR Part 117 and the EU Hygiene Package, principally Regulation 852/2004. It identifies requirements that are shared between both frameworks, requirements that are unique to one market, and any conflicts where a practice acceptable in one jurisdiction needs adjustment for the other. The output is a single action plan structured around one underlying system with market-specific additions clearly flagged.
Yes. For businesses handling foods on the FDA's Food Traceability List, the package includes FSMA 204 traceability planning ahead of the July 2028 deadline. For the EU side, the package includes the food safety culture requirements introduced by Regulation 2021/382, which became binding hygiene law in 2021 and are assessed by EU and UK enforcement authorities through observation and staff interviews.
Under FSMA, a Preventive Controls Qualified Individual, or PCQI, must develop or oversee your food safety plan. EU food law does not require an equivalent named role, but does require a competent HACCP team and, since Regulation 2021/382, evidence of leadership commitment to food safety culture. In practice, the same person or team can usually fulfil both roles, and the package includes guidance on structuring responsibilities so both requirements are met without duplicating effort.
Foreign facilities manufacturing, processing, packing or holding food for US consumption generally need to register with the FDA under section 415 of the Federal Food, Drug, and Cosmetic Act, and are then subject to the Preventive Controls for Human Food rule unless an exemption applies. The package includes guidance on registration requirements and confirms your facility's exemption status as part of the initial gap analysis, since FSMA exemptions are narrower than many businesses assume.
Audit preparation includes a mock inspection structured around how an FDA investigator would assess your food safety plan and records under 21 CFR Part 117, and a separate mock inspection structured around how an EU or UK competent authority would assess hygiene compliance and food safety culture under Regulation 852/2004 and Regulation 2021/382. Both mock inspections are conducted against the same underlying documentation, so findings from one often improve readiness for the other.
Our consulting work moves fast. Building a unified food safety management system that satisfies both frameworks typically takes 4 to 6 weeks, depending on the number of products and processes and your starting point. Facility registration processing times and audit or inspection scheduling by FDA and EU or UK authorities are outside our control, but our part of the process is structured to never be the bottleneck.
Yes. The gap analysis, unified food safety management system documentation, and dual-market training are all available remotely. We work with clients in any country exporting to or from the EU and US. On-site visits are available for mock inspections and where a physical process review is needed to confirm the process flow diagram and validate preventive controls.
Yes. The unified food safety management system built under this package, based on a HACCP and HARPC-aligned hazard analysis, forms a strong foundation for GFSI-recognised certification schemes such as FSSC 22000, BRCGS or IFS Food, which many buyers in both the EU and US markets require in addition to baseline regulatory compliance. We can scope certification work as an extension of this package once the dual-market foundation is in place.
You can commission any of these on their own, with an agreed scope and a written quote, without taking on ongoing consulting. See all food safety services.
Before committing to artwork for a new market.
Read about An export market label review →To check the whole operation against the law of each market.
Read about A regulatory compliance review →To confirm every substance is permitted in your category.
Read about An ingredient and additive review →Tell us about your products and where you currently trade, or where you want to expand. We will tell you exactly what the dual-market gap analysis will cover.