FMCG Product Compliance Checklist

Verify product name, ingredients list, allergens, nutrition declaration, net quantity, date marking, storage conditions, origin (where required), FBO name and address, alcohol % (if applicable), instructions for use (if needed), and lot/batch code are all present on the label.

All 14 Annex II allergens are highlighted using bold, CAPITALS, or underline in the ingredients list. If no ingredients list is present, allergen information is preceded by "Contains."

Energy (kJ/kcal), fat, saturates, carbohydrate, sugars, protein, salt -- in that order, per 100 g or 100 ml, in tabular format where space permits. Rounding follows Annex XV guidelines.

x-height of mandatory information is at least 1.2 mm. For packaging with the largest surface area below 80 cm2, the minimum x-height is 0.9 mm.

All mandatory information appears in the official language(s) of each Member State where the product is sold. Multi-market products have correct multilingual labels.

A documented HACCP-based hazard analysis covers all biological, chemical, and physical hazards in the production process. Critical control points (CCPs) are identified with validated limits and monitoring procedures.

Product complies with food safety criteria (e.g., Salmonella, Listeria monocytogenes) and process hygiene criteria for the relevant food category. Testing frequency is defined and results are within limits.

Heavy metals (lead, cadmium, mercury), mycotoxins (aflatoxins, ochratoxin A, deoxynivalenol), acrylamide, and other contaminants are within maximum levels set for the product category.

All packaging materials in direct contact with the food comply with EU framework regulation. Plastic materials meet specific migration limits (SMLs) and overall migration limits (OMLs). A declaration of compliance is on file from the packaging supplier.

All food additives, flavourings, and enzymes used in the product are authorised for the specific food category. Usage levels do not exceed maximum permitted levels. E-numbers are correctly declared in the ingredients list.

The production site holds a valid, in-date certification from a GFSI-benchmarked scheme (BRC Global Standard for Food Safety, IFS Food, FSSC 22000, or SQF). Audit grade and any non-conformances are reviewed.

Accelerated and/or real-time shelf-life studies support the declared best-before or use-by date. Studies cover microbiological, chemical, and sensory parameters at the declared storage conditions. Challenge testing is performed for chilled RTE products.

A complete product specification covers formulation, organoleptic attributes, physical parameters (pH, Aw, weight, dimensions), nutritional profile, allergen status, and packaging. Specifications are agreed and signed by relevant retail or distribution partners.

A documented product recall and withdrawal procedure is in place. A mock recall has been conducted within the last 12 months demonstrating the ability to trace and recover product within the required timeframe (typically 4 hours for high-risk products).

Each production batch undergoes sensory evaluation (appearance, smell, taste, texture) against a defined reference standard. Results are recorded with accept/reject criteria and corrective actions documented for any deviations.

The food business operator is registered with the competent food safety authority in each EU Member State where the product is placed on the market. Import notifications are filed where the product originates from outside the EU.

All nutrition claims (e.g., "low fat," "high fibre," "source of protein") meet the conditions in the Annex of Regulation 1924/2006. Health claims are authorised and appear on the EU Register. Wording matches the authorised claim text exactly.

The product and its ingredients have been checked against the EU Novel Food Catalogue. If any ingredient is classified as novel (not consumed to a significant degree in the EU before 15 May 1997), an EFSA authorisation application has been submitted or an existing authorisation confirmed.

If the product carries an organic claim or the EU organic logo, the producer holds a valid organic certificate from an accredited control body. Ingredients sourced as organic are covered by valid supplier organic certificates. The EU organic logo is displayed with the required code number and origin statement.

Extended producer responsibility (EPR) registrations are completed in each market (e.g., LUCID in Germany, Citeo in France). Deposit return scheme (DRS) obligations are met where applicable. Any country-specific labelling requirements (e.g., Italian decree on origin of primary ingredients) are addressed.

A single, version-controlled document contains the full product formulation, packaging specifications, label artwork (with approval stamps), and any regulatory correspondence. The file is accessible to quality, regulatory, and commercial teams.

Recent certificates of analysis (CoAs) are on file for: nutritional composition, allergen testing (including ELISA or PCR for cross-contamination risk assessment), contaminant screening, and microbiological testing. Certificates are from accredited (ISO 17025) laboratories.

Supplier declarations, specifications, and certificates of conformity are on file for all raw materials, ingredients, and packaging components. Approved supplier lists are maintained and reviewed annually. Due diligence covers food fraud vulnerability assessments (TACCP/VACCP).

One-step-back (suppliers) and one-step-forward (customers) traceability records are maintained. Batch-level traceability enables identification of all raw materials used in a finished product batch and all customers who received that batch. Records are retained for at least the shelf life of the product plus 6 months (or longer as required by national legislation).

A formal label approval process is documented. Each label version has a dated sign-off from regulatory affairs, quality assurance, and marketing. A change log tracks all revisions with the reason for change, the approver, and the date of approval. Superseded artwork is archived but clearly marked as obsolete.