Quick answer
Compliance means proving that every surface touching food is safe: stainless steel, plastic panels, rubber gaskets, coatings. In the EU the evidence is Regulation (EC) No 1935/2004 plus a declaration of compliance and supporting test data. In the United States it is a food contact substance clearance under the Federal Food, Drug, and Cosmetic Act. Both are documents, not a badge on the machine.
What does EU Regulation 1935/2004 actually require?
First, why a worktable needs a file at all. The regulation is written around contact, not around what the product is called: it applies to materials and articles which, in their finished state, are intended to be brought into contact with food, are already in contact with food and were intended for that purpose, or can reasonably be expected to come into contact with food or to transfer constituents to food under normal or foreseeable conditions of use. A prep table, a sink, a cold room panel, a mixer bowl and the rubber seal on a refrigerator door all sit inside that definition, and the regulation does not exempt equipment for being industrial or for its contact being incidental. The paperwork must therefore exist before installation, and it must cover the parts purchasing departments normally ignore.
Three obligations then sit at the centre: general safety, labelling, and documentation.
General requirements. Article 3(1) requires manufacture in compliance with good manufacturing practice, so that under normal or foreseeable conditions of use materials do not transfer constituents to food in quantities which could endanger human health, bring about an unacceptable change in the composition of the food, or deteriorate its organoleptic characteristics. Article 3(2) adds that labelling, advertising and presentation must not mislead.
Labelling. Article 15 requires materials not yet in contact with food to carry “for food contact”, a specific indication of use, or the Annex II symbol, plus instructions where needed and the name and address of the operator established in the Community. Information must be conspicuous, legible and indelible, in a language easily understood by purchasers.
Documentation and traceability. Article 16 requires a written declaration of compliance where a specific measure requires it, with supporting documentation produced to authorities on demand. Article 17 requires traceability at all stages.
Above that sits Commission Regulation (EC) No 2023/2006 on good manufacturing practice, covering all stages up to but excluding the production of starting substances: a documented quality assurance system (Article 5), an effective quality control system with corrective measures (Article 6), and documentation of specifications and processing records available on request (Article 7). Its Annex requires printing inks on the non-food-contact side to be formulated so substances are not transferred to the food-contact side, and printed surfaces must not contact food directly.
Where do metals and alloys sit in the EU system?
This is where buyers who assume CE marking settles it get caught. The Commission describes the framework as Regulation 1935/2004, GMP under 2023/2006, specific Union legislation on certain materials including plastic and ceramics, and national legislation on other materials. Metals and alloys fall into that last group: Article 6 of 1935/2004 states that, in the absence of specific measures, the regulation does not prevent Member States from maintaining or adopting national provisions, provided they comply with the rules of the Treaty.
For a stainless steel table shipped to the EU, the governing document is therefore not one harmonised text but the destination country’s national provision plus the Article 3 safety requirement. The practical question is not “is this EU compliant” but “which member state is the first point of entry, and what does it require for stainless steel in food contact”. A supplier who answers the first with a certificate and cannot answer the second has not done the work.
| Material in a typical unit | EU position | What the buyer should receive |
|---|---|---|
| Stainless steel surfaces, frames, sinks | Article 3 requirements; no harmonised specific measure | Composition by grade, declaration referencing Article 3, national-rule statement |
| Plastic panels, handles, boards | Regulation (EU) No 10/2011 | Declaration of compliance to Article 15 and Annex IV, with migration data |
| Rubber and silicone seals | Outside 10/2011, which excludes rubber and silicones | Separate elastomer declaration, GMP statement, migration data |
| Coatings, printing inks, adhesives | No specific EU measure of the same kind | Information for restricted-substance compliance |
What changes for plastic and rubber parts?
Plastic is the one group where a European buyer can demand a precise, testable document. Regulation (EU) No 10/2011 is a specific measure under Article 5 of 1935/2004: only substances on its Union list may be intentionally used in plastic layers, with derogations for polymer production aids, colorants and solvents (Article 6). Two limits do most of the work — the overall migration limit of 10 milligrams of total constituents per dm² of contact surface (Article 12), and the specific migration limits in Annex I, with a generic 60 mg/kg where none is listed (Article 11).
Article 15 requires a written declaration of compliance at marketing stages other than retail, containing the Annex IV information, identifying the product clearly and renewed when composition or production changes alter migration or when new scientific data appears. Article 16 requires supporting documentation — test conditions and results, calculations, or other analysis — on request.
Rubber and silicone are excluded by Article 2(2), which names ion exchange resins, rubber and silicones as materials intended to be covered by other specific measures. A door gasket is therefore not covered by the plastic declaration, and a file holding only the panel declaration is incomplete. Ask for the elastomer document separately, with its test medium and temperature: a gasket that survives a cold-room test is not automatically suitable for a steamer.
How is the US system different?
The American route is built on clearances rather than a declaration of compliance, and the vocabulary matters when quotations arrive from several countries. Under 21 CFR Part 174, substances safely used as components of articles that contact food include those generally recognised as safe, those under a prior sanction or approval, those permitted by regulations in Parts 174 to 178, and food contact substances used under an effective premarket notification (FCN) submitted under section 409(h) of the Act. The same part defines good manufacturing practice: the quantity added to food must not exceed, where no limits are specified, that resulting from use in an amount not more than reasonably required for the intended technical effect in the article, and must not be intended to accomplish any technical effect in the food itself.
A second route covers very low exposure. 21 CFR 170.39 exempts a substance from regulation as a food additive where it is not a carcinogen, has no carcinogenic impurity with a TD50 below 6.25 milligrams per kilogram bodyweight per day, and where use gives dietary concentrations at or below 0.5 parts per billion — at or below 1.5 micrograms per person per day, on a diet of 1,500 grams of solid and 1,500 grams of liquid food — with no technical effect on food.
| Question | EU | United States |
|---|---|---|
| Legal basis | Regulation (EC) No 1935/2004 plus specific measures such as 10/2011 | Federal Food, Drug, and Cosmetic Act; 21 CFR Parts 170 to 178 |
| Core instrument | Written declaration of compliance plus supporting test data | Regulation listing, effective FCN, GRAS position, or threshold exemption |
| Numerical anchors | OML 10 mg/dm²; generic SML 60 mg/kg | Dietary concentration 0.5 ppb, i.e. 1.5 µg/person/day, for the threshold route |
| GMP | Regulation (EC) No 2023/2006 | GMP restrictions in 21 CFR 174.5(a) |
| Metals | National provisions under Article 6 of 1935/2004 | Substance-by-substance clearance through the applicable listings |
Which documents should a buyer request?
A workable set for one unit is short enough to review in an afternoon, if it is agreed at order stage rather than after delivery.
| Document | What it demonstrates | What to check |
|---|---|---|
| Declaration of compliance, plastic parts | Conformity with 10/2011 Article 15 | Product identification, Annex IV content, revision date |
| Elastomer declaration, seals | Rubber or silicone conformity outside 10/2011 | Test medium, temperature, contact time |
| Material statement, stainless steel | Grade and composition behind the Article 3 claim | Grade by standard, not by trade name |
| GMP statement | Quality assurance and control per 2023/2006 | Reference to the system, not a logo |
| Migration test report | Worst-case migration results | Conditions matched to real use |
| US clearance reference | FCN number, regulation citation or threshold exemption | That it covers the intended use |
| Traceability record | Article 17 identification | Batch and date link to the file |
Two habits make the list work. Tie every document to a part number rather than a product family, because a file covering “refrigerated counter” rarely covers the batch shipped. And re-check the file when a component changes — a new gasket supplier, a different handle, a reformulated coating. Article 15(3) of 10/2011 makes renewal an obligation when changes alter migration.
Zhongji Metal has manufactured stainless steel commercial kitchen and cold storage equipment in Shandong, China since 2010 and exports to more than 130 countries. Food contact documentation is assembled per order rather than per catalogue page: the stainless steel workbench range is supplied with a grade and composition statement against the general requirements of 1935/2004, the refrigerated workbench is documented together with its elastomer seals so the gasket file is not left behind, and the modular cold room is supplied with the panel and door-seal documentation the destination market asks for. Declarations of compliance are available for EU-bound orders, and the national provision applicable in the member state of first entry is confirmed with the buyer before shipment. The full range is on our Alibaba.com storefront.
Frequently asked questions
Does CE marking cover food contact materials?
No. CE marking addresses the product regulations that apply to the appliance, typically electrical safety, electromagnetic compatibility and machinery where relevant. Food contact materials are assessed under Regulation (EC) No 1935/2004 and its specific measures, with national provisions for groups such as metals. A complete file for a kitchen appliance contains both sets of evidence.
Is there an EU-wide rule for stainless steel in food contact?
There is no harmonised specific measure for metals and alloys. The Commission describes the framework as Regulation 1935/2004, GMP under 2023/2006, specific Union legislation on certain materials such as plastic and ceramics, and national legislation on other materials. Article 6 of 1935/2004 allows Member States to maintain or adopt national provisions where specific measures are absent.
Which regulation applies to a plastic panel or cutting board?
Regulation (EU) No 10/2011, a specific measure under Article 5 of 1935/2004. It restricts plastic layers to substances on the Union list, sets an overall migration limit of 10 mg per dm² of contact surface, sets specific migration limits with a generic 60 mg/kg where none is listed, and requires a written declaration of compliance at non-retail marketing stages.
Are rubber door gaskets covered by the plastics regulation?
No. Article 2(2) of 10/2011 excludes ion exchange resins, rubber and silicones, which are intended to be covered by other specific measures. A refrigerator or cold room gasket needs its own declaration from the elastomer supplier, covering the test medium, temperature and contact time relevant to the intended use.
What is the US equivalent of a declaration of compliance?
There is no single equivalent. The US system works through permitted uses in 21 CFR Parts 174 to 178, effective food contact notifications under section 409(h) of the Act, GRAS positions, and threshold-of-regulation exemptions under 21 CFR 170.39 at or below 0.5 parts per billion dietary concentration. Suppliers usually pass this through as a clearance statement citing the specific route.
Who actually holds the file, supplier or buyer?
Both, in different ways. The business operator placing the material or article on the market issues the declaration and keeps the supporting documentation available to authorities under Article 16 of 1935/2004 and Article 7 of 2023/2006. The buyer holds the copies that came with the shipment and should keep them for as long as the equipment remains in service, refreshing them when a component changes.
Local codes vary; verify requirements with your authority having jurisdiction.
Sources
- Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food — Articles 3, 6, 15, 16 and 17.
- Commission Regulation (EC) No 2023/2006 on good manufacturing practice — quality assurance, quality control, documentation, printing inks.
- Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food — Union list, Article 2(2) exclusions, migration limits, declaration of compliance.
- European Commission — Food contact materials — framework, GMP, specific Union legislation and national legislation.
- 21 CFR Part 174 — Indirect Food Additives: General — GMP restrictions, permitted bases of use, and the reference to the threshold of regulation in 21 CFR 170.39.
Author: China Zhongji Metal
WhatsApp: +86 190 5035 2733
Website: https://zhongjimetal.com
Alibaba.com: https://zhongjimetal.en.alibaba.com
