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Regulatory compliance review

Your operation assessed against the food law of every market you sell into, with the provision behind each finding cited and the action stated.

What is a regulatory compliance review?

A regulatory compliance review assesses a food business against the food law that genuinely applies to it, in every market where it places product. It covers registration and approval, hygiene requirements, HACCP obligations, labelling and information rules, traceability, and any category specific regulation attached to what you produce. The output is a compliance register marking each requirement compliant, at risk or noncompliant, with the action needed.

Requirements diverge between markets in both directions, so clearing the strictest market does not clear the rest. A product can meet composition rules in one country and fail them in the next, and a label compliant in one language market can be unlawful in another for reasons that have nothing to do with translation.

Summary

Each market assessed against its own legislation, with the provision cited behind every finding. Delivered remotely, in any language, quoted on scope.

Compliance review at a glance

Assessed against
The food law of every market you sell into
Covers
Registration, hygiene, composition, labelling, traceability
Categories
Including supplements, fortified and novel foods
Delivery
Remote
Coverage
Worldwide
Output
Compliance register with sources cited
Excludes
Legal advice and representation
Languages
Any language, including English, Spanish, French, German, Italian and Portuguese

What the review covers

Six layers of obligation, each assessed per market. The right hand column is what goes wrong most often at each layer.

LayerWhat it coversCommon exposure
Establishment requirementsRegistration or approval of the site, the activities permitted under it, and any category specific licensing.Operating an activity outside what the registration covers.
Hygiene and process obligationsGeneral hygiene requirements, HACCP based procedures, and the operational rules attached to your process type.A HACCP based procedure that exists and does not match the operation.
Product composition rulesPermitted ingredients and additives, maximum levels, contaminants, and category specific compositional standards.An additive authorised for one food category used in another.
Information and labellingMandatory particulars, allergen declaration, nutrition, claims, language obligations and country of origin.Labels compliant in one market and not in the next one along.
Traceability and incident dutiesOne step back and one step forward at minimum, plus the duty to withdraw, recall and notify.A traceability system never tested against the legal timeframe.
Market entry and notificationNotification or authorisation for certain product categories, import requirements and certification for entry.Placing a food supplement or fortified food without the required national notification.

How compliance gaps open up

Almost nobody sets out to be noncompliant. These eight are how the position drifts without anyone deciding it should.

What you receive

Every entry cites its source, so each finding can be checked and defended.

ElementWhat it holds
Scope statementThe markets, product categories and activities the review covers, agreed before work starts.
Compliance registerEach applicable requirement listed with its source, marked compliant, at risk or noncompliant.
Source citationThe regulation, article or provision behind every entry, so each finding is traceable.
Market by market viewRequirements presented per market, since a product can be compliant in one and not in another.
Risk ratingFindings prioritised by legal exposure and by likelihood of enforcement.
Action requiredWhat closing each gap involves, specified in full.
Category flagsWhere a product falls into a regime carrying additional obligations, identified explicitly.
Watch listThe provisions most likely to change, so monitoring can be assigned.

Who a regulatory compliance review is for

Manufacturers, processors, importers, exporters, brand owners and food supplement companies. It suits any business selling into more than one market, and any business that has never separated legal compliance from certification.

You are entering a new market and need the requirements before committing.

Product has been exported without the destination rules being checked.

A recipe or formulation change has not been reassessed for compliance.

You have moved into supplements, fortified or novel food territory.

A customer or distributor has queried your legal position.

An authority has raised a question and you need to know where you stand.

Nobody in the business is monitoring regulatory change.

You have been certified for years and never checked legal compliance separately.

How the review is carried out

  • 1

    Market and product scope

    You confirm where product is placed, the product categories and the activities carried out at each site.

  • 2

    Requirement mapping

    Applicable requirements are identified per market, including any category specific regime attached to your products.

  • 3

    Evidence gathering

    Registrations, approvals, specifications, recipes, labels, procedures and records are collected.

  • 4

    Assessment

    Each requirement is assessed against the evidence and marked compliant, at risk or noncompliant, with the provision cited.

  • 5

    Risk rating

    Findings are prioritised by legal exposure and by likelihood of enforcement, so the urgent items are visible.

  • 6

    Register and watch list

    The register is issued alongside a watch list of provisions most likely to change.

Not included

Legal advice and representation. This is a technical compliance review, and where a position is genuinely contested or enforcement is in prospect, a lawyer is needed.

Closing the gaps is separate work, though the register specifies what each one involves.

Where a finding indicates product currently on the market is noncompliant, you are told immediately and separately, because the response to that is time sensitive.

What a regulatory compliance review costs

Every review is quoted against its own scope. One product in one market and a range across six markets are very different pieces of work. These factors set the price.

Markets in scope

Product categories

Operation type

Number of sites

What this service is assessed against

These are the primary sources this work is built on. Where a market you sell into has its own requirement, that takes precedence and we assess against it.

Regulation (EC) No 178/2002, general food law
Traceability duties, the withdrawal and recall obligation, and the duty to notify the competent authority. EUR-Lex
Regulation (EC) No 852/2004 on the hygiene of foodstuffs
The general hygiene requirements and the duty to operate procedures based on HACCP principles. EUR-Lex
Regulation (EU) No 1169/2011 on food information to consumers
Mandatory particulars, allergen declaration, quantitative ingredient declaration, nutrition declaration and legibility. EUR-Lex
21 CFR Part 117, preventive controls for human food
The FSMA hazard analysis and risk based preventive controls requirements, including validation and verification. eCFR
Regulation (EU) 2015/2283 on novel foods
Which ingredients require authorisation before being placed on the market. EUR-Lex

Food law terms

Food business operator
The person or company responsible for ensuring food law requirements are met within the business under their control.
Placing on the market
Holding food for the purpose of sale, and the point at which most legal obligations attach.
Competent authority
The national or local body responsible for enforcing food law in a given market.
Registration
Notification to an authority that a food business is operating, required in most jurisdictions before trading.
Approval
A higher level of authorisation required for certain activities, normally involving inspection before operating.
Mandatory particulars
The information food law requires to appear on a label or accompany a food.
Novel food
A food without significant consumption history in a given market before a defined date, requiring authorisation before sale.
Compliance register
The documented list of applicable legal requirements with the current position against each.

Regulatory compliance questions

It is an assessment of a food business against the food law that applies to it, in every market where it places product. It covers registration and approval, hygiene and HACCP obligations, product composition, labelling and information, traceability, and any category specific regime attached to what you produce. The output is a register marking each requirement compliant, at risk or noncompliant, with the action needed.

Whichever markets you sell into. The review is built from your market list, and each market is assessed against its own legislation, because requirements diverge considerably. Tell us where product is placed and the register is built market by market.

No, and the assumption is a common source of exposure. Certification standards and food law overlap substantially and are separate obligations enforced by different bodies. A certified site can be operating outside the scope of its registration or placing product that does not meet composition or labelling requirements.

A label review assesses what appears on pack against information law. This review covers the whole operation, including registration, approval, hygiene obligations, composition, traceability duties and market entry requirements. Labelling is one part of it, and businesses needing only the label checked should take the narrower service.

The register states what the gap is, what the requirement is, where it comes from and what closing it involves. Findings are prioritised by legal exposure. Where a finding indicates product currently on the market is noncompliant, that is flagged immediately and separately, because the response to it is time sensitive.

Food law changes continuously, so a position established once decays. Annual review is common for stable operations. A review is warranted sooner whenever a recipe changes, a new market opens, a new product category is entered, or a supplier of a critical ingredient changes.

Yes, and they need particular attention. Permitted forms, maximum levels, mandatory warnings and national notification requirements differ substantially between markets, including between countries that otherwise share a regulatory framework.

Yes, and it is the cheaper time to do it. Establishing the requirements before committing to artwork, formulation and distribution costs far less than discovering a compositional or notification problem after launch.

Guidance is useful for interpretation and it is not the requirement. Where guidance and legislation diverge, the legislation governs, and enforcement is against the law. The review cites the provision behind every entry for that reason.

No. This is a technical compliance review identifying what the law requires and where you stand against it. Where a position is genuinely contested, or enforcement action is in prospect, that needs a lawyer and the review says so at the point it becomes relevant.

Yes. Scope is agreed at the start, and multi site or multi product reviews are usually more efficient as one project because requirements overlap. Where sites operate under different registrations or approvals, each is assessed separately.

A scope statement, a compliance register with the source cited for each requirement, a market by market view, risk ratings, the action needed for each gap, flags where a product falls into a regime with additional obligations, and a watch list of provisions likely to change.

Who carries out this work

Confi Food assigns work by subject. HACCP, labelling, certification standards, regulatory compliance, supplier assurance and monitoring are separate disciplines, and each piece goes to someone who works in that area. Every deliverable is reviewed internally by a second specialist before it reaches you.

Our technical positions are built from primary sources, meaning the legislation, the competent authority, Codex Alimentarius, the certification scheme owner or the relevant standards body. We set out how that works in our technical review and editorial policy, and what happens at each stage of an engagement in how Confi Food works.

Related services

Request a compliance review

Tell us the markets, the products and the activities, and receive a written quote covering the scope, the deliverable and the price.