{ "$schema": "https://www.conphora.com/schemas/regulation-page.json", "code": "CER", "locale": "en", "url": "https://www.conphora.com/regulations/cer/", "json": "https://www.conphora.com/regulations/cer.json", "summaryPdf": "https://www.conphora.com/regulations/cer/summary.pdf", "dateModified": "2026-09-11", "regulation": { "code": "CER", "name": "Council Directive 84/500/EEC of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs", "shortName": "Ceramics Directive", "reference": "Council Directive 84/500/EEC", "celex": "31984L0500", "eurlex": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31984L0500", "actType": "Directive", "category": "Food & Cosmetics", "inForce": "1984-10-17", "appliesFrom": "1989-10-17", "changing": false, "video": "regulation-cer" }, "answer": "The Ceramics Directive caps the lead and cadmium that ceramic tableware, cooking ware and storage vessels for food contact may release into food, and requires a written declaration of compliance from the manufacturer or an EU-established seller. Non-compliant articles have been banned since 17 October 1989, and the declaration rules of Commission Directive 2005/31/EC apply from 20 May 2006.", "description": "CER guide: the Ceramics Directive on lead and cadmium migration from ceramic articles for food contact, who it applies to, the limits per category, the acetic-acid test, the declaration of compliance, the Danish rules, key dates and how to comply.", "enforcedBy": "Member States enforce the national laws transposing the directive through the official controls of the food contact materials framework, Regulation (EC) No 1935/2004, of which the directive is a specific measure; in Denmark, Fødevarestyrelsen (the Danish Veterinary and Food Administration) administers the rules: executive order nr. 681 of 25 May 2020 on food contact materials was issued by Fødevarestyrelsen under the Danish food act (sections 25, 25 a, 49(1) and 60(3)) and delegated powers, it implements the directive, extends the same lead and cadmium limits to enamelled articles and glassware, adds a mouth-rim limit for drinking vessels and makes Fødevarestyrelsen the authority to be notified when non-compliant materials are withdrawn. The toolkit is the marketing ban for non-compliant articles, the operator's duty to withdraw them, notify Fødevarestyrelsen and inform or recall from consumers, the authorities' right to demand the declaration of compliance and the underlying test documentation, temporary national suspension of the EU limits on health grounds, and national sanctions that must be effective, proportionate and dissuasive, which in Denmark are fines and up to two years' imprisonment for intentional or grossly negligent infringements that harm or endanger health or seek an economic gain.", "keyDates": [ { "date": "1984-10-15", "label": "Council Directive 84/500/EEC adopted by the Council in Luxembourg", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31984L0500 · title and signature block after Art. 6" }, { "date": "1984-10-17", "label": "Directive notified to the Member States; the transposition periods of Article 5 run from this date", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 5(1) and footnote 5 to Art. 4(1)" }, { "date": "1984-10-20", "label": "Publication in OJ L 277 of 20 October 1984, page 12", "source": "https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31984L0500 · OJ L 277, 20.10.1984, p. 12" }, { "date": "1987-10-17", "label": "Three years after notification: Member States must permit trade in ceramic articles that comply with the directive; deadline for the Council to set limits for the areas that touch the mouth and for the Commission to re-examine the limits and the lighting conditions of the test", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 4 and Art. 5(1), first indent" }, { "date": "1989-10-17", "label": "Five years after notification: placing on the market of ceramic articles that do not comply with the directive is prohibited; Member States may also prohibit their manufacture", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 5(1), second indent, and Art. 5(2)" }, { "date": "2004-12-03", "label": "Regulation (EC) No 1935/2004 in force: the framework for all food contact materials, with ceramics as one of the 17 material groups for which specific measures may be adopted; Directive 89/109/EEC repealed", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 5(1), Art. 26, Art. 28 and Annex I, point 3" }, { "date": "2005-05-20", "label": "Commission Directive 2005/31/EC in force, the twentieth day after publication in OJ L 110 of 30 April 2005: it inserts Article 2a on the declaration of compliance, replaces Annex II with performance criteria for the analytical method and adds Annex III", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031 · Art. 1 and Art. 3" }, { "date": "2006-05-20", "label": "Deadline for Member States to adopt and publish the laws transposing Directive 2005/31/EC; trade in and use of ceramic articles complying with it must be permitted from this date", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031 · Art. 2(1), first subparagraph and point (a)" }, { "date": "2006-10-27", "label": "Article 17 of Regulation (EC) No 1935/2004 applies: traceability systems to identify the businesses from which and to which ceramic articles were supplied", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 17 and Art. 28" }, { "date": "2007-05-20", "label": "Manufacture and importation into the Community of ceramic articles that do not comply with Directive 2005/31/EC (declaration of compliance, supporting documentation, analytical performance criteria) prohibited", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031 · Art. 2(1), point (b)" }, { "date": "2008-08-01", "label": "Regulation (EC) No 2023/2006 on good manufacturing practice applies to all sectors and to all stages of manufacture, processing and distribution of food contact materials, up to but excluding the production of starting substances, ceramics included", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023 · Art. 1, Art. 2 and Art. 8" }, { "date": "2019-12-14", "label": "Regulation (EU) 2017/625 on official controls applies and repeals Regulation (EC) No 882/2004, which Article 24(3) of the framework regulation still cites", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0625 · Art. 146(1) and Art. 167(1)" }, { "date": "2020-07-01", "label": "Danish executive order nr. 681 of 25 May 2020 on food contact materials in force, replacing order nr. 1248 of 30 October 2018: it implements the directive, applies the same lead and cadmium limits to ceramic and enamelled articles and glassware, adds a mouth-rim limit and requires the ceramics declaration of compliance up to and including retail", "source": "https://www.retsinformation.dk/eli/lta/2020/681 · footnote 1, § 14, § 15, § 25 and bilag 4, 5 and 6" }, { "date": "2025-07-17", "label": "TRIS notification 2025/0387/DK received: Denmark notifies a draft order that would repeal order nr. 681 of 25 May 2020, take effect on 1 January 2026 and apply lower lead and cadmium limits, expressed in micrograms, to ceramic and enamelled articles and glassware from 1 July 2026; standstill extended to 19 January 2026, Spain issued a detailed opinion, and as at 17 September 2026 Retsinformation still lists order nr. 681 as the order in force", "source": "https://technical-regulation-information-system.ec.europa.eu/en/notification/27084 · notification detail; https://technical-regulation-information-system.ec.europa.eu/en/notification/27084/text/D/DA · § 10, § 16 and bilag 5; https://www.retsinformation.dk/eli/lta/2020/681 · document status" } ], "amendedBy": [ { "reference": "Commission Directive 2005/31/EC", "celex": "32005L0031", "date": "2005-05-20", "summary": "The Commission directive of 29 April 2005, adopted under Article 5(2) of Regulation (EC) No 1935/2004 and published in OJ L 110 on 30 April 2005, inserted Article 2a: ceramic articles not yet in contact with food must be accompanied at all marketing stages up to and including retail by a written declaration of compliance issued by the manufacturer or a seller established in the Community, and the manufacturer or importer must make the analysis results, test conditions and laboratory details available to the authorities on request. It replaced Annex II with performance criteria for any instrumental method of analysis (detection limits of 0,1 mg/l lead and 0,01 mg/l cadmium, quantification limits of 0,2 and 0,02 mg/l, recovery of 80 to 120 %) and added Annex III with the content of the declaration. Member States had to transpose it by 20 May 2006, permit compliant articles from that date and prohibit manufacture and import of non-compliant articles from 20 May 2007.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031 · recitals 1 to 5, Art. 1, Art. 2 and Art. 3; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a, Annex II and Annex III (M1)" } ], "scope": { "appliesTo": [ "Ceramic articles which, in their finished state, are intended to come into contact with foodstuffs, or which are in contact with foodstuffs and are intended for that purpose (Art. 1(2))", "Ceramic means manufactured from a mixture of inorganic materials with a generally high argillaceous or silicate content, to which small quantities of organic materials may have been added, shaped and then permanently fixed by firing; the articles may be glazed, enamelled and/or decorated (Art. 1(3))", "Articles are sorted into three categories: articles which cannot be filled and fillable articles no deeper than 25 mm (category 1), all other articles which can be filled (category 2), and cooking ware and packaging and storage vessels with a capacity of more than three litres (category 3); in practice that covers plates, dishes and other flatware, cups, mugs, bowls, jugs and other hollowware, cooking ware and ceramic storage vessels (Art. 2(4))", "Vessels fitted with a ceramic lid, tested as vessel and lid separately with the sum related to the vessel alone (Art. 2(3))", "The manufacturer of the finished article, the seller established in the Union that issues the declaration, and the importer into the Union that must hold the test documentation (Art. 2a and Annex III)" ], "derived": [ "Article 1(1) still calls the directive a specific directive under Article 3 of Directive 76/893/EEC; Directive 89/109/EEC repealed that directive and provided that references to it are construed as references to Directive 89/109/EEC (Art. 10), and Regulation (EC) No 1935/2004 in turn repealed Directive 89/109/EEC and provided that references to the repealed directives are construed as references to the regulation (Art. 26), so the reference in Article 1(1) is read as a reference to Regulation (EC) No 1935/2004, and Directive 2005/31/EC describes the ceramics directive as a specific measure within the meaning of Article 5 of that regulation, so the framework's general requirements, labelling, traceability and controls apply on top of the lead and cadmium limits", "Because the framework regulation does not apply to materials and articles supplied as antiques, antique ceramics fall outside the food contact regime, while the directive itself contains no antiques clause (Regulation (EC) No 1935/2004, Art. 1(3)(a))", "Article 4(1)(a) required the Council to set, within three years of notification, limitations for the areas of ceramic articles that touch the mouth; the consolidated text of 20 May 2005 contains no such rim limit, so the EU limits apply to the vessel as a whole, whereas the Danish order sets a separate mouth-rim limit for drinking vessels (bilag 4, kategori I, point 3)", "Ceramics are one of the 17 material groups in Annex I to Regulation (EC) No 1935/2004; glass and enamelled metal are separate groups with no EU specific measure, so national rules under Article 6 of the framework regulation apply to them, and Denmark applies the ceramics limits to enamelled articles and glassware nationally (order nr. 681 of 25 May 2020, § 14)", "Good manufacturing practice under Regulation (EC) No 2023/2006 applies to every business operator manufacturing ceramic food contact articles from 1 August 2008, at all stages up to but excluding the production of starting substances (Art. 1, Art. 2 and Art. 8)" ], "categories": [ { "id": "flatware-shallow", "label": "Plate, dish, saucer, tile or other ceramic article that cannot be filled, or can be filled but is no deeper than 25 mm (category 1)" }, { "id": "hollowware", "label": "Cup, mug, bowl, jug, teapot or other fillable ceramic article deeper than 25 mm (category 2)" }, { "id": "cooking-storage", "label": "Ceramic cooking ware, or ceramic packaging and storage vessels with a capacity above three litres (category 3)" }, { "id": "lidded-vessel", "label": "Ceramic vessel fitted with a ceramic lid (casserole, tureen, storage jar)" }, { "id": "drinking-vessel-rim", "label": "Ceramic mug, cup or beaker drunk from directly, where the rim touches the mouth" }, { "id": "filled-ceramic-packaging", "label": "Ceramic packaging already filled with food when sold (stoneware jar, crock, bottle)" }, { "id": "decorative-ceramic", "label": "Decorative ceramic article not intended to come into contact with food (vase, ornament, wall plate)" }, { "id": "glass-enamel-metal", "label": "Glass, crystal or enamelled metal article for food contact (not ceramic)" }, { "id": "antique-ceramic", "label": "Ceramic article supplied as an antique" } ], "roles": [ { "id": "operator", "label": "Business operator (any stage of manufacture, processing or distribution)", "definition": "The natural or legal persons responsible for ensuring that the requirements of the food contact materials framework are met within the business under their control; a business is any undertaking, whether for profit or not and whether public or private, carrying out any activity related to any stage of manufacture, processing and distribution of materials and articles. For ceramics the directive names three of them: the manufacturer, the seller established in the Community and the importer.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 2(2), points (c) and (d); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a" }, { "id": "manufacturer", "label": "Manufacturer of the finished ceramic article", "definition": "The company which manufactures the finished ceramic article, whose identity and address must appear in the declaration of compliance; it issues that declaration for articles not yet in contact with food and must make the analysis results, test conditions and the name and address of the testing laboratory available to the national competent authorities on request.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a(1), Art. 2a(2) and Annex III, point 1" }, { "id": "importer", "label": "Importer into the Union, or seller established in the Union responsible for placing on the market", "definition": "The importer who imports the ceramic article into the Community, whose identity and address must appear in the declaration of compliance alongside the manufacturer's and who, like the manufacturer, must make the supporting test documentation available to the authorities on request; as a seller established within the Community it may itself issue the declaration. Under the framework regulation its name and address must accompany the article as the seller responsible for placing on the market established within the Community, and the Danish order treats the importer like the producer for withdrawal and notification.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a(1), Art. 2a(2) and Annex III, point 1; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 15(1)(c); https://www.retsinformation.dk/eli/lta/2020/681 · § 7" }, { "id": "distributor", "label": "Distributor, wholesaler or retailer", "definition": "A business at the marketing stages after manufacture or import, up to and including the retail stage, that holds ceramic articles for sale or transfers them; the declaration of compliance must accompany the articles at every one of those stages, the labelling information must be displayed at retail in a language purchasers easily understand, and the business must be able to identify its suppliers and customers.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a(1); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 2(1)(b), Art. 15(4), Art. 15(7) and Art. 17(2)" } ], "rules": [ { "categories": [ "decorative-ceramic" ], "roles": [ "*" ], "size": "any", "result": "out-of-scope", "note": "The directive concerns only ceramic articles which, in their finished state, are intended to come into contact with foodstuffs or are in contact with foodstuffs for that purpose; the declaration of compliance was introduced precisely to distinguish food contact ceramics from decorative articles. A decorative article must not be presented in a way that misleads consumers into using it for food.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 1(2); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031 · recital 3; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 3(2)" }, { "categories": [ "glass-enamel-metal" ], "roles": [ "*" ], "size": "any", "result": "out-of-scope", "note": "Glass and enamelled metal are not ceramic articles under Article 1(3) and have no EU specific measure; they stay under the general requirements of Regulation (EC) No 1935/2004 and any national measures adopted under its Article 6. In Denmark, order nr. 681 of 25 May 2020 applies the same lead and cadmium limits and the same test to enamelled articles and glassware.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 1(3); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 3, Art. 6 and Annex I, points 3, 6 and 8; https://www.retsinformation.dk/eli/lta/2020/681 · § 14 and § 16" }, { "categories": [ "antique-ceramic" ], "roles": [ "*" ], "size": "any", "result": "depends", "note": "Regulation (EC) No 1935/2004 does not apply to materials and articles supplied as antiques, and the directive is a specific measure under that regulation; the directive itself has no antiques clause, so whether an old ceramic article is supplied as an antique or as tableware for use decides the outcome. Fødevarestyrelsen warns consumers that old glazed ceramics, heirlooms and flea-market finds can contain lead, and that colourful glazes are the typical source.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 1(3)(a); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031 · recital 1; https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/materialetyper/keramik; https://foedevarestyrelsen.dk/kost-og-foedevarer/alt-om-mad/kemi-i-maden/koekkengrej" }, { "categories": [ "flatware-shallow" ], "roles": [ "manufacturer", "importer", "distributor", "operator" ], "size": "any", "result": "in-scope", "note": "Category 1 articles, which cannot be filled or have an internal depth of no more than 25 mm measured from the lowest point to the plane through the upper rim, may release at most 0,8 mg/dm² of lead and 0,07 mg/dm² of cadmium in the Annex I test; the surface area is that of the free liquid surface when filled as prescribed.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(4) and Annex I, point 4" }, { "categories": [ "hollowware" ], "roles": [ "manufacturer", "importer", "distributor", "operator" ], "size": "any", "result": "in-scope", "note": "Category 2, all other articles which can be filled, may release at most 4,0 mg/l of lead and 0,3 mg/l of cadmium when filled with 4 % acetic acid to within 1 mm of the overflow point for 24 hours at 22 °C.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(4) and Annex I, points 2.1 and 3.1" }, { "categories": [ "cooking-storage" ], "roles": [ "manufacturer", "importer", "distributor", "operator" ], "size": "any", "result": "in-scope", "note": "Category 3 covers cooking ware, with no capacity threshold, and packaging and storage vessels with a capacity of more than three litres; both have the stricter limits of 1,5 mg/l of lead and 0,1 mg/l of cadmium.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(4)" }, { "categories": [ "lidded-vessel" ], "roles": [ "manufacturer", "importer", "distributor", "operator" ], "size": "any", "result": "in-scope", "note": "Where a ceramic article is a vessel fitted with a ceramic lid, the limit is the one that applies to the vessel alone; the vessel and the inner surface of the lid are tested separately under the same conditions and the two extraction levels are added and related to the surface area or volume of the vessel alone.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(3)" }, { "categories": [ "drinking-vessel-rim" ], "roles": [ "manufacturer", "importer", "distributor", "operator" ], "size": "any", "result": "in-scope", "note": "A mug or cup is a category 2 article under the directive, which sets no separate limit for the rim: the mouth-contact limitations foreseen in Article 4(1)(a) do not appear in the consolidated text of 20 May 2005. In Denmark, drinking vessels must in addition meet the category I limit of 0,8 mg/dm² lead and 0,07 mg/dm² cadmium on a 2 cm band along the upper edge, inside and outside.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(4) and Art. 4(1)(a); https://www.retsinformation.dk/eli/lta/2020/681 · bilag 4, kategori I, point 3 and note 2, and bilag 6, part A, point 2.3 and the following unnumbered paragraph on the determination of the surface area of category I articles" }, { "categories": [ "filled-ceramic-packaging" ], "roles": [ "manufacturer", "importer", "distributor", "operator" ], "size": "any", "result": "in-scope", "note": "Ceramic articles already in contact with foodstuffs and intended for that purpose are within the directive and must meet the category limits; the written declaration of compliance is required only for articles not yet in contact with foodstuffs, but the test documentation must still be available to the authorities on request.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 1(2), Art. 2a(1) and Art. 2a(2)" }, { "categories": [ "*" ], "roles": [ "*" ], "size": "any", "result": "depends", "note": "Whether the directive applies turns on whether the article is ceramic within Article 1(3), whether it is intended for food contact, which of the three categories its shape and capacity place it in, and which role the business holds in the chain; the directive contains no company-size threshold.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 1, Art. 2(4) and Art. 2a" } ] }, "obligations": { "manufacturer": [ { "text": "Keep the lead and cadmium released by each article within the limit for its category: 0,8 mg/dm² lead and 0,07 mg/dm² cadmium for category 1 (non-fillable or up to 25 mm deep), 4,0 mg/l and 0,3 mg/l for category 2 (other fillable articles), 1,5 mg/l and 0,1 mg/l for category 3 (cooking ware, packaging and storage vessels above three litres).", "id": "cer-mfr-keep-lead-cadmium", "kind": "evidence", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(1) and Art. 2(4)" }, { "text": "Determine migration with the Annex I test: 4 % (v/v) acetic acid freshly prepared, 22 ± 2 °C for 24 ± 0,5 hours, fillable articles filled to within 1 mm of the overflow point (6 mm along a flat or sloping rim), non-fillable articles immersed after protecting the non-contact surface, the sample covered and kept in total darkness when cadmium is determined, and lidded vessels tested as vessel and lid separately.", "id": "cer-mfr-determine-migration-annex", "kind": "procedure", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(2), Art. 2(3) and Annex I, points 1 to 4" }, { "text": "Use an instrumental method of analysis that meets the Annex II performance criteria: detection limits of at most 0,1 mg/l lead and 0,01 mg/l cadmium, quantification limits of at most 0,2 and 0,02 mg/l, recovery of 80 to 120 %, freedom from matrix and spectral interference, a blank for each series, and samples washed in household detergent at about 40 °C and not handled on the test surface afterwards.", "id": "cer-mfr-use-instrumental-method", "kind": "procedure", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Annex II, points 2, 4 and 5 (M1)" }, { "text": "Rely on the tolerance only as the directive allows: an article exceeding a limit by no more than 50 % still passes if at least three other articles of the same shape, dimensions, decoration and glaze are tested and their average does not exceed the limit, with none of them exceeding it by more than 50 %.", "id": "cer-mfr-rely-tolerance-directive", "kind": "procedure", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(5)" }, { "text": "Issue the written declaration of compliance for articles not yet in contact with food, so that it accompanies them at every marketing stage up to and including retail, stating your identity and address and those of the importer into the Union, the identity of the article, the date, and the confirmation that the article meets the relevant requirements of the directive and of Regulation (EC) No 1935/2004; make it easy to match to the goods and renew it when substantial changes in production alter the lead or cadmium migration.", "id": "cer-mfr-issue-written-declaration", "kind": "evidence", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a(1) and Annex III" }, { "text": "Keep appropriate documentation demonstrating compliance with the migration limits, containing the results of the analysis carried out, the test conditions and the name and address of the laboratory that performed the testing, and make it available to the national competent authorities on request.", "id": "cer-mfr-keep-appropriate-documentation", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a(2)" }, { "text": "Manufacture under good manufacturing practice with a documented quality assurance system, a quality control system and records of specifications, formulae, processing and controls available to the authorities, so that the articles do not transfer constituents to food in quantities that endanger health, change the food unacceptably or spoil its taste or smell.", "id": "cer-mfr-manufacture-good-manufacturing", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 3(1); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023 · Art. 4, Art. 5, Art. 6 and Art. 7" }, { "text": "Manufacture under good manufacturing practice with a documented quality assurance system and a quality control system, so that the articles do not transfer constituents to food in quantities that endanger health, change the food unacceptably or spoil its taste or smell.", "id": "cer-mfr-apply-good-manufacturing-practice", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 3(1); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023 · Art. 4, Art. 5 and Art. 6" }, { "text": "Keep documentation on specifications, formulae, processing and quality control results and make it available to the competent authorities on request.", "id": "cer-mfr-keep-gmp-documentation", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023 · Art. 7" }, { "text": "Label articles not yet in contact with food with the words for food contact, a specific indication of use or the Annex II symbol unless the article is clearly intended for food contact, any special instructions for safe use, your name or trade name and address, and the identification that ensures traceability; keep systems that identify the businesses you supplied and were supplied by.", "id": "cer-mfr-label-articles-yet", "kind": "mark", "level": "product", "timing": "before-market", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 15(1), Art. 15(2), Art. 15(3) and Art. 17(2)" }, { "text": "Label articles not yet in contact with food with the words for food contact, a specific indication of use or the Annex II symbol, unless the article is clearly intended for food contact, and with any special instructions for safe and appropriate use.", "id": "cer-mfr-label-food-contact-use", "kind": "mark", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 15(1), points (a) and (b), and Art. 15(2)" }, { "text": "Put your name or trade name and address or registered office on the article, its packaging, a label or the accompanying documents.", "id": "cer-mfr-mark-name-address", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 15(1), point (c)" }, { "text": "Label or otherwise identify the articles so that they can be traced.", "id": "cer-mfr-label-traceability", "kind": "mark", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 15(1), point (d), and Art. 17(2)" }, { "text": "Keep systems and procedures that identify the businesses you supplied and the businesses that supplied you, and make that information available to the competent authorities on demand.", "id": "cer-mfr-keep-traceability-systems", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 17(2)" } ], "importer": [ { "text": "Import only ceramic articles that meet the category limits: since 20 May 2007 Member States must prohibit the importation into the Union of ceramic articles that do not comply with the directive as amended by Directive 2005/31/EC.", "id": "cer-imp-import-ceramic-articles", "kind": "verification", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031 · Art. 2(1), point (b); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(4)" }, { "text": "Make sure a written declaration of compliance accompanies the articles from your first sale onwards; it may be issued by the manufacturer or by you as a seller established in the Union, and it must name both the manufacturer of the finished article and you as the importer, identify the article, carry a date and confirm compliance with the directive and Regulation (EC) No 1935/2004.", "id": "cer-imp-make-sure-written", "kind": "verification", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a(1) and Annex III" }, { "text": "Hold the supporting documentation, the analysis results, test conditions and the name and address of the testing laboratory, and make it available to the national competent authorities on request; the directive places this duty on the importer into the Union as well as on the manufacturer.", "id": "cer-imp-hold-supporting-documentation", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "technical-documentation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a(2)" }, { "text": "Put your name or trade name and address on the article, its packaging or a label as the seller responsible for placing on the market established within the Union, ensure the for food contact indication and any instructions are present, and keep traceability records of your suppliers and customers.", "id": "cer-imp-put-name-trade", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 15(1), points (a) to (d), and Art. 17(2)" }, { "text": "Put your name or trade name and address on the article, its packaging or a label as the seller established in the Union responsible for placing it on the market.", "id": "cer-imp-mark-name-address", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 15(1), point (c)" }, { "text": "Check that the for food contact indication and any special instructions for use are on the article, its packaging or a label.", "id": "cer-imp-check-food-contact-labelling", "kind": "verification", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 15(1), points (a) and (b)" }, { "text": "Keep systems and procedures that identify your suppliers and your business customers, and make that information available to the competent authorities on demand.", "id": "cer-imp-keep-traceability-systems", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 17(2)" }, { "text": "In Denmark, if you consider or have reason to believe that ceramics you imported do not meet the food safety requirements and are no longer under your control, withdraw them from the market, notify Fødevarestyrelsen immediately and, where they have reached consumers, inform the consumers effectively and if necessary recall the articles.", "id": "cer-imp-consider-have-reason", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://www.retsinformation.dk/eli/lta/2020/681 · § 7" }, { "text": "In Denmark, also check drinking vessels against the mouth-rim limit and apply the same limits and test to enamelled articles and glassware, and make the ceramics declaration and background documentation available in the form the Danish order prescribes, including the option of publishing the declaration on your website if the next links in the chain are informed.", "id": "cer-imp-check-drinking-vessels", "kind": "verification", "level": "product", "timing": "before-market", "retired": "2026-09-24", "source": "https://www.retsinformation.dk/eli/lta/2020/681 · § 14, § 15(1) and (2), bilag 4 and bilag 5, point 4" }, { "text": "In Denmark, also check drinking vessels against the mouth-rim limit, and apply the same limits and test to enamelled articles and glassware.", "id": "cer-imp-check-mouth-rim-limits", "kind": "verification", "level": "product", "timing": "before-market", "source": "https://www.retsinformation.dk/eli/lta/2020/681 · § 14 and bilag 4" }, { "text": "In Denmark, make the ceramics declaration and background documentation available in the form the Danish order prescribes; the declaration may be published on your website if the next links in the chain are informed.", "id": "cer-imp-provide-danish-declaration-form", "kind": "evidence", "level": "product", "timing": "before-market", "source": "https://www.retsinformation.dk/eli/lta/2020/681 · § 15(1) and (2) and bilag 5, point 4" } ], "distributor": [ { "text": "Sell only ceramic articles that are accompanied by the written declaration of compliance; the directive requires it at all marketing stages up to and including the retail stage for articles not yet in contact with food.", "id": "cer-dist-sell-ceramic-articles", "kind": "verification", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a(1)" }, { "text": "At the retail stage, display the labelling information on the article, its packaging, a label or a clearly visible notice nearby, and do not sell articles whose for food contact indication and instructions are not given in a language purchasers easily understand.", "id": "cer-dist-retail-stage-display", "kind": "data", "level": "product-market", "timing": "at-listing", "sharedKey": "instructions-and-safety-information", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 15(4) and Art. 15(7)" }, { "text": "Keep systems and procedures that identify the businesses from which and to which the articles were supplied, and make that information available to the competent authorities on demand.", "id": "cer-dist-keep-systems-procedures", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 17(2)" }, { "text": "In Denmark, do not market food contact materials that fail the general requirements, and as the responsible business withdraw non-compliant ceramics you have distributed, notify Fødevarestyrelsen and inform consumers where the articles have reached them.", "id": "cer-dist-market-food-contact", "kind": "submission", "level": "product", "timing": "on-event", "source": "https://www.retsinformation.dk/eli/lta/2020/681 · § 6(1) and § 7" } ], "operator": [ { "text": "Ensure that the ceramic articles under your control do not, under normal or foreseeable conditions of use, transfer their constituents to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food or deteriorate its taste, smell or appearance, and that their labelling, advertising and presentation do not mislead consumers.", "id": "cer-op-ensure-ceramic-articles", "kind": "evidence", "level": "product", "timing": "before-market", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 3" }, { "text": "Operate an effective and documented quality assurance system proportionate to the size of the business, a quality control system that detects and corrects failures, and documentation on specifications, processing and control results available to the authorities.", "id": "cer-op-operate-effective-documented", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023 · Art. 5, Art. 6 and Art. 7" }, { "text": "Operate an effective and documented quality assurance system proportionate to the size of the business, and a quality control system that detects and corrects failures.", "id": "cer-op-apply-good-manufacturing-practice", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023 · Art. 5 and Art. 6" }, { "text": "Keep documentation on specifications, processing and quality control results, and make it available to the competent authorities on request.", "id": "cer-op-keep-gmp-documentation", "kind": "standing", "level": "company", "timing": "ongoing", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023 · Art. 7" }, { "text": "Have documentation available that demonstrates compliance with the specific measure and hand it to the competent authorities on demand; a food business that fills or uses ceramic articles must in Denmark use only compliant materials and only for their intended purpose.", "id": "cer-op-have-documentation-available", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 16(1); https://www.retsinformation.dk/eli/lta/2020/681 · § 6(2)" }, { "text": "Where a specific measure applies, have documentation available that demonstrates compliance with it, and hand it to the competent authorities on demand.", "id": "cer-op-provide-compliance-documentation", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 16(1)" }, { "text": "Cooperate with the official controls that Member States carry out under the Union rules on official food and feed controls, now Regulation (EU) 2017/625, with the EU and national reference laboratories for food contact materials supporting the analytical work.", "id": "cer-op-cooperate-official-controls", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "retired": "2026-09-24", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 24; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0625 · Art. 146(1)" } ] }, "requirements": [ { "id": "cer-mfr-keep-lead-cadmium", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "text": "Keep the lead and cadmium released by each article within the limit for its category: 0,8 mg/dm² lead and 0,07 mg/dm² cadmium for category 1 (non-fillable or up to 25 mm deep), 4,0 mg/l and 0,3 mg/l for category 2 (other fillable articles), 1,5 mg/l and 0,1 mg/l for category 3 (cooking ware, packaging and storage vessels above three litres).", "article": "Art. 2(1) and Art. 2(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520" }, { "id": "cer-mfr-determine-migration-annex", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "before-market", "text": "Determine migration with the Annex I test: 4 % (v/v) acetic acid freshly prepared, 22 ± 2 °C for 24 ± 0,5 hours, fillable articles filled to within 1 mm of the overflow point (6 mm along a flat or sloping rim), non-fillable articles immersed after protecting the non-contact surface, the sample covered and kept in total darkness when cadmium is determined, and lidded vessels tested as vessel and lid separately.", "article": "Art. 2(2), Art. 2(3) and Annex I, points 1 to 4", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520" }, { "id": "cer-mfr-use-instrumental-method", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "before-market", "text": "Use an instrumental method of analysis that meets the Annex II performance criteria: detection limits of at most 0,1 mg/l lead and 0,01 mg/l cadmium, quantification limits of at most 0,2 and 0,02 mg/l, recovery of 80 to 120 %, freedom from matrix and spectral interference, a blank for each series, and samples washed in household detergent at about 40 °C and not handled on the test surface afterwards.", "article": "Annex II, points 2, 4 and 5 (M1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520" }, { "id": "cer-mfr-rely-tolerance-directive", "role": "manufacturer", "kind": "procedure", "level": "product", "timing": "before-market", "text": "Rely on the tolerance only as the directive allows: an article exceeding a limit by no more than 50 % still passes if at least three other articles of the same shape, dimensions, decoration and glaze are tested and their average does not exceed the limit, with none of them exceeding it by more than 50 %.", "article": "Art. 2(5)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520" }, { "id": "cer-mfr-issue-written-declaration", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "text": "Issue the written declaration of compliance for articles not yet in contact with food, so that it accompanies them at every marketing stage up to and including retail, stating your identity and address and those of the importer into the Union, the identity of the article, the date, and the confirmation that the article meets the relevant requirements of the directive and of Regulation (EC) No 1935/2004; make it easy to match to the goods and renew it when substantial changes in production alter the lead or cadmium migration.", "article": "Art. 2a(1) and Annex III", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520" }, { "id": "cer-mfr-keep-appropriate-documentation", "role": "manufacturer", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "text": "Keep appropriate documentation demonstrating compliance with the migration limits, containing the results of the analysis carried out, the test conditions and the name and address of the laboratory that performed the testing, and make it available to the national competent authorities on request.", "article": "Art. 2a(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520" }, { "id": "cer-mfr-manufacture-good-manufacturing", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "text": "Manufacture under good manufacturing practice with a documented quality assurance system, a quality control system and records of specifications, formulae, processing and controls available to the authorities, so that the articles do not transfer constituents to food in quantities that endanger health, change the food unacceptably or spoil its taste or smell.", "article": "Art. 3(1); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023 · Art. 4, Art. 5, Art. 6 and Art. 7", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-mfr-apply-good-manufacturing-practice", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Manufacture under good manufacturing practice with a documented quality assurance system and a quality control system, so that the articles do not transfer constituents to food in quantities that endanger health, change the food unacceptably or spoil its taste or smell.", "article": "Art. 3(1); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023 · Art. 4, Art. 5 and Art. 6", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-mfr-keep-gmp-documentation", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep documentation on specifications, formulae, processing and quality control results and make it available to the competent authorities on request.", "article": "Art. 7", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023" }, { "id": "cer-mfr-label-articles-yet", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "retired": "2026-09-24", "text": "Label articles not yet in contact with food with the words for food contact, a specific indication of use or the Annex II symbol unless the article is clearly intended for food contact, any special instructions for safe use, your name or trade name and address, and the identification that ensures traceability; keep systems that identify the businesses you supplied and were supplied by.", "article": "Art. 15(1), Art. 15(2), Art. 15(3) and Art. 17(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-mfr-label-food-contact-use", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "text": "Label articles not yet in contact with food with the words for food contact, a specific indication of use or the Annex II symbol, unless the article is clearly intended for food contact, and with any special instructions for safe and appropriate use.", "article": "Art. 15(1), points (a) and (b), and Art. 15(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-mfr-mark-name-address", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "text": "Put your name or trade name and address or registered office on the article, its packaging, a label or the accompanying documents.", "article": "Art. 15(1), point (c)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-mfr-label-traceability", "role": "manufacturer", "kind": "mark", "level": "product", "timing": "before-market", "text": "Label or otherwise identify the articles so that they can be traced.", "article": "Art. 15(1), point (d), and Art. 17(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-mfr-keep-traceability-systems", "role": "manufacturer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep systems and procedures that identify the businesses you supplied and the businesses that supplied you, and make that information available to the competent authorities on demand.", "article": "Art. 17(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-imp-import-ceramic-articles", "role": "importer", "kind": "verification", "level": "product", "timing": "before-market", "text": "Import only ceramic articles that meet the category limits: since 20 May 2007 Member States must prohibit the importation into the Union of ceramic articles that do not comply with the directive as amended by Directive 2005/31/EC.", "article": "Art. 2(1), point (b); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(4)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031" }, { "id": "cer-imp-make-sure-written", "role": "importer", "kind": "verification", "level": "product", "timing": "before-market", "text": "Make sure a written declaration of compliance accompanies the articles from your first sale onwards; it may be issued by the manufacturer or by you as a seller established in the Union, and it must name both the manufacturer of the finished article and you as the importer, identify the article, carry a date and confirm compliance with the directive and Regulation (EC) No 1935/2004.", "article": "Art. 2a(1) and Annex III", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520" }, { "id": "cer-imp-hold-supporting-documentation", "role": "importer", "kind": "standing", "level": "product", "timing": "ongoing", "sharedKey": "technical-documentation", "text": "Hold the supporting documentation, the analysis results, test conditions and the name and address of the testing laboratory, and make it available to the national competent authorities on request; the directive places this duty on the importer into the Union as well as on the manufacturer.", "article": "Art. 2a(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520" }, { "id": "cer-imp-put-name-trade", "role": "importer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "retired": "2026-09-24", "text": "Put your name or trade name and address on the article, its packaging or a label as the seller responsible for placing on the market established within the Union, ensure the for food contact indication and any instructions are present, and keep traceability records of your suppliers and customers.", "article": "Art. 15(1), points (a) to (d), and Art. 17(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-imp-mark-name-address", "role": "importer", "kind": "mark", "level": "product", "timing": "before-market", "sharedKey": "identification-and-address", "text": "Put your name or trade name and address on the article, its packaging or a label as the seller established in the Union responsible for placing it on the market.", "article": "Art. 15(1), point (c)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-imp-check-food-contact-labelling", "role": "importer", "kind": "verification", "level": "product", "timing": "before-market", "text": "Check that the for food contact indication and any special instructions for use are on the article, its packaging or a label.", "article": "Art. 15(1), points (a) and (b)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-imp-keep-traceability-systems", "role": "importer", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep systems and procedures that identify your suppliers and your business customers, and make that information available to the competent authorities on demand.", "article": "Art. 17(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-imp-consider-have-reason", "role": "importer", "kind": "submission", "level": "product", "timing": "on-event", "text": "In Denmark, if you consider or have reason to believe that ceramics you imported do not meet the food safety requirements and are no longer under your control, withdraw them from the market, notify Fødevarestyrelsen immediately and, where they have reached consumers, inform the consumers effectively and if necessary recall the articles.", "article": "§ 7", "sourceUrl": "https://www.retsinformation.dk/eli/lta/2020/681" }, { "id": "cer-imp-check-drinking-vessels", "role": "importer", "kind": "verification", "level": "product", "timing": "before-market", "retired": "2026-09-24", "text": "In Denmark, also check drinking vessels against the mouth-rim limit and apply the same limits and test to enamelled articles and glassware, and make the ceramics declaration and background documentation available in the form the Danish order prescribes, including the option of publishing the declaration on your website if the next links in the chain are informed.", "article": "§ 14, § 15(1) and (2), bilag 4 and bilag 5, point 4", "sourceUrl": "https://www.retsinformation.dk/eli/lta/2020/681" }, { "id": "cer-imp-check-mouth-rim-limits", "role": "importer", "kind": "verification", "level": "product", "timing": "before-market", "text": "In Denmark, also check drinking vessels against the mouth-rim limit, and apply the same limits and test to enamelled articles and glassware.", "article": "§ 14 and bilag 4", "sourceUrl": "https://www.retsinformation.dk/eli/lta/2020/681" }, { "id": "cer-imp-provide-danish-declaration-form", "role": "importer", "kind": "evidence", "level": "product", "timing": "before-market", "text": "In Denmark, make the ceramics declaration and background documentation available in the form the Danish order prescribes; the declaration may be published on your website if the next links in the chain are informed.", "article": "§ 15(1) and (2) and bilag 5, point 4", "sourceUrl": "https://www.retsinformation.dk/eli/lta/2020/681" }, { "id": "cer-dist-sell-ceramic-articles", "role": "distributor", "kind": "verification", "level": "product", "timing": "before-market", "text": "Sell only ceramic articles that are accompanied by the written declaration of compliance; the directive requires it at all marketing stages up to and including the retail stage for articles not yet in contact with food.", "article": "Art. 2a(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520" }, { "id": "cer-dist-retail-stage-display", "role": "distributor", "kind": "data", "level": "product-market", "timing": "at-listing", "sharedKey": "instructions-and-safety-information", "text": "At the retail stage, display the labelling information on the article, its packaging, a label or a clearly visible notice nearby, and do not sell articles whose for food contact indication and instructions are not given in a language purchasers easily understand.", "article": "Art. 15(4) and Art. 15(7)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-dist-keep-systems-procedures", "role": "distributor", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep systems and procedures that identify the businesses from which and to which the articles were supplied, and make that information available to the competent authorities on demand.", "article": "Art. 17(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-dist-market-food-contact", "role": "distributor", "kind": "submission", "level": "product", "timing": "on-event", "text": "In Denmark, do not market food contact materials that fail the general requirements, and as the responsible business withdraw non-compliant ceramics you have distributed, notify Fødevarestyrelsen and inform consumers where the articles have reached them.", "article": "§ 6(1) and § 7", "sourceUrl": "https://www.retsinformation.dk/eli/lta/2020/681" }, { "id": "cer-op-ensure-ceramic-articles", "role": "operator", "kind": "evidence", "level": "product", "timing": "before-market", "text": "Ensure that the ceramic articles under your control do not, under normal or foreseeable conditions of use, transfer their constituents to food in quantities that could endanger human health, bring about an unacceptable change in the composition of the food or deteriorate its taste, smell or appearance, and that their labelling, advertising and presentation do not mislead consumers.", "article": "Art. 3", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-op-operate-effective-documented", "role": "operator", "kind": "standing", "level": "company", "timing": "ongoing", "retired": "2026-09-24", "text": "Operate an effective and documented quality assurance system proportionate to the size of the business, a quality control system that detects and corrects failures, and documentation on specifications, processing and control results available to the authorities.", "article": "Art. 5, Art. 6 and Art. 7", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023" }, { "id": "cer-op-apply-good-manufacturing-practice", "role": "operator", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Operate an effective and documented quality assurance system proportionate to the size of the business, and a quality control system that detects and corrects failures.", "article": "Art. 5 and Art. 6", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023" }, { "id": "cer-op-keep-gmp-documentation", "role": "operator", "kind": "standing", "level": "company", "timing": "ongoing", "text": "Keep documentation on specifications, processing and quality control results, and make it available to the competent authorities on request.", "article": "Art. 7", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023" }, { "id": "cer-op-have-documentation-available", "role": "operator", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "retired": "2026-09-24", "text": "Have documentation available that demonstrates compliance with the specific measure and hand it to the competent authorities on demand; a food business that fills or uses ceramic articles must in Denmark use only compliant materials and only for their intended purpose.", "article": "Art. 16(1); https://www.retsinformation.dk/eli/lta/2020/681 · § 6(2)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-op-provide-compliance-documentation", "role": "operator", "kind": "evidence", "level": "product", "timing": "before-market", "sharedKey": "technical-documentation", "text": "Where a specific measure applies, have documentation available that demonstrates compliance with it, and hand it to the competent authorities on demand.", "article": "Art. 16(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "id": "cer-op-cooperate-official-controls", "role": "operator", "kind": "standing", "level": "company", "timing": "ongoing", "sharedKey": "authority-cooperation", "retired": "2026-09-24", "text": "Cooperate with the official controls that Member States carry out under the Union rules on official food and feed controls, now Regulation (EU) 2017/625, with the EU and national reference laboratories for food contact materials supporting the analytical work.", "article": "Art. 24; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0625 · Art. 146(1)", "sourceUrl": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" } ], "requirementsHash": "8793c1444f1227d0", "penalties": { "text": "The directive contains no penalty article of its own: Member States had to amend their national laws so that trade in compliant ceramic articles was permitted from 17 October 1987 and the placing on the market of non-compliant articles was prohibited from 17 October 1989, and they may prohibit the manufacture of non-compliant articles. Sanctions come from the framework: Member States lay down the rules on sanctions for infringements of Regulation (EC) No 1935/2004, which must be effective, proportionate and dissuasive, enforce the rules through official controls, and may temporarily suspend or restrict the application of the EU limits on their territory where they have detailed grounds for concluding that an article endangers human health although it complies. In Denmark, executive order nr. 681 of 25 May 2020 prohibits the marketing of food contact materials that fail the general requirements, obliges the responsible business, producer or importer to withdraw non-compliant materials, notify Fødevarestyrelsen and inform or recall from consumers, and punishes with a fine infringements of the lead and cadmium limits and test rules for ceramic and enamelled articles and glassware, of the declaration and documentation duty, of Articles 3, 4(1) and (3) to (6), 11(5), 15 and 17 of the framework regulation and of Articles 4 to 7 of the good manufacturing practice regulation; the penalty rises to imprisonment of up to two years where the infringement was intentional or grossly negligent and harmed or endangered health or sought an economic gain, and companies can be held criminally liable.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 5; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 18, Art. 24 and Art. 25; https://www.retsinformation.dk/eli/lta/2020/681 · § 6, § 7, § 17, § 18 and § 19" }, "checklist": [ "Confirm each article is ceramic under Article 1(3) (inorganic mixture, shaped and fixed by firing, possibly glazed, enamelled or decorated) and is intended for food contact; treat decorative pieces, glass and enamelled metal separately and check the Danish rules for the latter two.", "Classify every article into category 1, 2 or 3 from its shape, internal depth (25 mm) and capacity (three litres), and note lidded vessels and drinking vessels for the lid rule and, in Denmark, the rim limit (Article 2(3) and 2(4); bilag 4).", "Have the food contact surface tested under Annex I conditions, 4 % acetic acid for 24 hours at 22 °C, by a laboratory whose instrumental method meets the Annex II detection, quantification and recovery criteria, and keep the report with the test conditions and the laboratory's name and address (Article 2a(2)).", "Compare the results with the category limits, applying the 50 % tolerance only with three further articles of the same shape, dimensions, decoration and glaze (Article 2(5)); pay particular attention to coloured glazes and decorations, which Fødevarestyrelsen recommends making without lead and cadmium.", "Draw up the written declaration of compliance with the four Annex III elements, manufacturer and importer identity and address, article identity, date and the confirmation of compliance with the directive and Regulation (EC) No 1935/2004, and make sure it travels with the goods up to and including retail (Article 2a(1)).", "Set a trigger for renewing the declaration and retesting when a glaze, decoration, firing process or supplier changes in a way that could alter lead or cadmium migration (Annex III, last paragraph).", "Apply the framework duties: good manufacturing practice with documented quality assurance and control (Regulation (EC) No 2023/2006), labelling with the for food contact indication where needed and the responsible seller's name and address (Article 15), and traceability records of suppliers and customers (Article 17).", "In Denmark, register the withdrawal and notification procedure towards Fødevarestyrelsen (§ 7 of order nr. 681 of 25 May 2020) and decide whether the declaration will accompany the goods or be published on your website with the chain informed (§ 15(2)).", "Follow the Danish draft order notified as TRIS 2025/0387/DK, which would lower the lead and cadmium limits to microgram levels from 1 July 2026, and the Commission's work on revised EU limits for lead, cadmium and other metals from ceramic and vitreous food contact materials, so that new products are designed to the coming limits." ], "faq": [ { "q": "What are the lead and cadmium limits under the Ceramics Directive?", "a": "Three categories. Category 1, articles which cannot be filled and fillable articles whose internal depth from the lowest point to the plane through the upper rim does not exceed 25 mm: 0,8 mg/dm² lead and 0,07 mg/dm² cadmium. Category 2, all other articles which can be filled: 4,0 mg/l lead and 0,3 mg/l cadmium. Category 3, cooking ware (with no capacity threshold) and packaging and storage vessels with a capacity of more than three litres: 1,5 mg/l lead and 0,1 mg/l cadmium. For a vessel with a ceramic lid the vessel's limit applies to the sum of the two extraction levels. Denmark applies the same numbers under order nr. 681 of 25 May 2020 and adds a category I rim limit for drinking vessels.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(3) and Art. 2(4); https://www.retsinformation.dk/eli/lta/2020/681 · § 14 and bilag 4" }, { "q": "Which articles does the directive cover, and which are outside it?", "a": "It covers ceramic articles which, in their finished state, are intended to come into contact with foodstuffs or are already in contact with foodstuffs for that purpose. Ceramic means manufactured from a mixture of inorganic materials with a generally high argillaceous or silicate content, possibly with small quantities of organic materials, shaped and permanently fixed by firing, glazed, enamelled or decorated or not. Decorative ceramics not meant for food are outside it, and so are glass and enamelled metal, which are separate material groups under the framework regulation without an EU specific measure; articles supplied as antiques are outside the framework regulation altogether.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 1(2) and Art. 1(3); https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 1(3)(a), Art. 6 and Annex I" }, { "q": "How is lead and cadmium migration from ceramics tested?", "a": "The article is washed in a household detergent solution at about 40 °C, rinsed and dried, then brought into contact with a freshly prepared 4 % (v/v) acetic acid solution at 22 ± 2 °C for 24 ± 0,5 hours. Fillable articles are filled to no more than 1 mm from the overflow point, or 6 mm measured along a flat or slightly sloping rim; non-fillable articles are immersed after the non-contact surface has been protected. The sample is covered, in usual laboratory lighting when only lead is determined and in total darkness when cadmium is determined. Lead and cadmium in the solution are then measured by an instrumental method meeting the Annex II criteria: detection limits of 0,1 mg/l lead and 0,01 mg/l cadmium, quantification limits of 0,2 and 0,02 mg/l and recovery of 80 to 120 %. For category 1 the result is related to the area of the free liquid surface, for categories 2 and 3 to the volume.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Annex I, points 1 to 4, and Annex II, points 4 and 5 (M1)" }, { "q": "Do I need a declaration of compliance for ceramic tableware, and what must it contain?", "a": "Yes, since Directive 2005/31/EC. Ceramic articles not yet in contact with food must be accompanied at the marketing stages up to and including retail by a written declaration under Article 16 of Regulation (EC) No 1935/2004, issued by the manufacturer or by a seller established in the Union. It must give the identity and address of the company that manufactures the finished article and of the importer into the Union, the identity of the article, the date, and the confirmation that the article meets the relevant requirements of the directive and of the framework regulation; it must allow easy identification of the goods and be renewed when substantial changes in production alter the lead or cadmium migration. Member States had to permit compliant articles from 20 May 2006 and prohibit manufacture and import of non-compliant ones from 20 May 2007.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a(1) and Annex III; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031 · Art. 2(1)" }, { "q": "Who is responsible when ceramics are imported from outside the EU?", "a": "The importer into the Union. The directive requires the manufacturer or the importer to make the documentation proving compliance with the limits, with the analysis results, the test conditions and the name and address of the testing laboratory, available to the national competent authorities on request, and the declaration of compliance must name the importer alongside the manufacturer; as a seller established in the Union the importer may issue the declaration itself. Under the framework regulation the importer's name and address must accompany the article as the seller responsible for placing on the market, and in Denmark the importer must withdraw non-compliant ceramics, notify Fødevarestyrelsen and inform consumers.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2a and Annex III, point 1; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 15(1)(c); https://www.retsinformation.dk/eli/lta/2020/681 · § 7" }, { "q": "Are the Danish rules for ceramics different from the EU directive?", "a": "Denmark implements the directive through executive order nr. 681 of 25 May 2020, in force since 1 July 2020. The lead and cadmium limits in its bilag 4 are the same numbers as the directive's, but the order applies them to enamelled articles and glassware as well as ceramics and adds a category I limit for the mouth rim of drinking vessels, tested on a 2 cm band along the upper edge; mugs must meet both the rim limit and the category II limit. The declaration of compliance for ceramics must accompany the goods up to and including retail, or may be published on the producer's or importer's website if the next links in the chain are informed, and infringements are fined, with up to two years' imprisonment in aggravated cases. A draft replacement order with much lower limits was notified to the Commission as TRIS 2025/0387/DK in July 2025; as at 17 September 2026 Retsinformation still lists order nr. 681 as the order in force.", "source": "https://www.retsinformation.dk/eli/lta/2020/681 · § 14, § 15, § 17, § 25, bilag 4, 5 and 6; https://technical-regulation-information-system.ec.europa.eu/en/notification/27084" }, { "q": "Is the EU going to lower the lead and cadmium limits for ceramics?", "a": "The Commission says on its revision page that exposure to lead and cadmium may be of concern, that those metals are sometimes released in significant amounts from ceramic and vitreous food contact materials, and that it has initiated action to lower the migration limits for lead and cadmium and to introduce limits for aluminium, arsenic, barium, cobalt, chromium and nickel, with transition and derogation options for artisanal producers. No amending act has been adopted: the consolidated text of the directive is still that of 20 May 2005, and the Commission describes itself as working towards revised legislation after a roadmap of 18 December 2020 and a public consultation from 5 October 2022 to 11 January 2023. Denmark has meanwhile notified a draft national order with lower limits: it bases the ceramics limits on the safeguard clause in Article 18 of the framework regulation and the glass and enamel limits on the national-measures clause in Article 6.", "source": "https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/revision-eu-rules_en; https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31984L0500; https://technical-regulation-information-system.ec.europa.eu/en/notification/27084/message/113713/EN" }, { "q": "What happens if an article exceeds a limit only slightly?", "a": "Article 2(5) gives a tolerance: where an article exceeds the limit by no more than 50 %, it is still recognised as compliant if at least three other articles with the same shape, dimensions, decoration and glaze are tested under Annexes I and II, the average lead or cadmium extracted from them does not exceed the limit, and none of them exceeds it by more than 50 %. Denmark carries the same rule in § 14(2) of order nr. 681 of 25 May 2020. An article that fails beyond that must not be placed on the market, and in Denmark must be withdrawn with notification to Fødevarestyrelsen.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2(5) and Art. 5(1); https://www.retsinformation.dk/eli/lta/2020/681 · § 7 and § 14(2)" } ], "changelog": [ { "date": "2026-09-11", "kind": "guidance", "title": "Guide rebuilt from the consolidated text and the Danish order", "summary": "The body was rewritten from the consolidated text of 20 May 2005, Directive 2005/31/EC, Regulation (EC) No 1935/2004 and executive order nr. 681 of 25 May 2020. The old text gave no figures; the limits, test conditions, declaration content and dates are now quoted from the acts. Two corrections: the transposition dates run from the notification of 17 October 1984 (trade in compliant articles permitted from 17 October 1987, non-compliant articles banned from 17 October 1989), and the current Danish limits are the same numbers as the directive's, extended to enamel and glass with a rim limit, while the lower Danish limits exist only as a notified draft.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 2, Art. 2a, Art. 5 and Annexes I to III; https://www.retsinformation.dk/eli/lta/2020/681 · § 14 and bilag 4" }, { "date": "2025-07-17", "kind": "guidance", "title": "Denmark notifies a draft order with lower lead and cadmium limits (TRIS 2025/0387/DK)", "summary": "The draft would repeal order nr. 681 of 25 May 2020 on 1 January 2026 and, from 1 July 2026, allow ceramic and enamelled articles and glassware on the Danish market only within new limits expressed in micrograms per dm² or litre, with articles lawfully marketed before that date sold until stocks are exhausted. Denmark bases the ceramics limits on the safeguard clause of Article 18 of Regulation (EC) No 1935/2004 and the glass and enamel limits on Article 6; the Commission and Latvia commented, Spain issued a detailed opinion and the standstill was extended to 19 January 2026. As at 17 September 2026 Retsinformation still lists order nr. 681 as in force.", "source": "https://technical-regulation-information-system.ec.europa.eu/en/notification/27084 · notification detail; https://technical-regulation-information-system.ec.europa.eu/en/notification/27084/message/113713/EN; https://technical-regulation-information-system.ec.europa.eu/en/notification/27084/text/D/DA · § 1(2), § 10 and § 16" }, { "date": "2020-07-01", "kind": "guidance", "title": "Danish executive order nr. 681 of 25 May 2020 in force", "summary": "The order implements Directive 84/500/EEC as amended by Directive 2005/31/EC, replaces order nr. 1248 of 30 October 2018, applies the directive's lead and cadmium limits to ceramic and enamelled articles and glassware with a mouth-rim limit for drinking vessels, requires the ceramics declaration of compliance up to and including retail, and penalises infringements with fines and up to two years' imprisonment.", "source": "https://www.retsinformation.dk/eli/lta/2020/681 · footnote 1, § 14, § 15, § 17 and § 25" }, { "date": "2008-08-01", "kind": "applies", "title": "Good manufacturing practice regulation applies", "summary": "Regulation (EC) No 2023/2006 applies to all sectors and to all stages of manufacture, processing and distribution of the material groups in Annex I to the framework regulation, up to but excluding the production of starting substances, ceramics included: documented quality assurance and quality control systems and records available to the authorities.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023 · Art. 1, Art. 2, Art. 4 to Art. 7 and Art. 8" }, { "date": "2007-05-20", "kind": "applies", "title": "Manufacture and import of ceramics without the 2005 requirements prohibited", "summary": "From this date Member States prohibit the manufacture and importation into the Community of ceramic articles that do not comply with the directive as amended by Directive 2005/31/EC.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031 · Art. 2(1), point (b)" }, { "date": "2006-05-20", "kind": "applies", "title": "Declaration of compliance and new analytical criteria apply", "summary": "Deadline for transposing Directive 2005/31/EC; from this date Member States permit trade in and use of ceramic articles complying with the amended directive, with the written declaration of compliance under Article 2a and Annex III and an analytical method meeting the Annex II performance criteria.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031 · Art. 2(1), first subparagraph and point (a)" }, { "date": "2005-05-20", "kind": "amendment", "title": "Commission Directive 2005/31/EC in force", "summary": "The amending directive of 29 April 2005, published in OJ L 110 on 30 April 2005, inserted Article 2a on the written declaration of compliance and the supporting documentation, replaced Annex II with performance criteria for the method of analysis and added Annex III with the content of the declaration.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031 · Art. 1 and Art. 3" }, { "date": "2004-12-03", "kind": "applies", "title": "Framework Regulation (EC) No 1935/2004 in force", "summary": "The framework regulation entered into force on the twentieth day after publication in OJ L 338 of 13 November 2004, repealed Directive 89/109/EEC (which had repealed Directive 76/893/EEC, the basis cited in Article 1(1) of the ceramics directive) and lists ceramics in Annex I as a group for which specific measures are adopted; its general requirements, labelling, declaration, traceability, control and sanction articles apply to ceramic articles alongside the directive.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327 · Art. 3, Art. 5, Art. 15 to Art. 17, Art. 24 to Art. 26, Art. 28 and Annex I; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31989L0109 · Art. 10" }, { "date": "1989-10-17", "kind": "applies", "title": "Non-compliant ceramic articles banned from the market", "summary": "Five years after notification, Member States must prohibit the placing on the market of ceramic articles that do not comply with the directive; they may also prohibit or continue to prohibit their manufacture.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 5(1), second indent, and Art. 5(2)" }, { "date": "1987-10-17", "kind": "applies", "title": "Trade in compliant ceramic articles must be permitted", "summary": "Three years after notification, Member States must have amended their laws so that trade in ceramic articles complying with the directive is permitted; the same deadline applied to the Council's decision on mouth-contact limitations and the Commission's re-examination of the limits, neither of which appears in the consolidated text.", "source": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · Art. 4 and Art. 5(1), first indent" }, { "date": "1984-10-17", "kind": "in-force", "title": "Council Directive 84/500/EEC notified to the Member States", "summary": "Adopted on 15 October 1984 and published in OJ L 277 on 20 October 1984, the directive took effect on notification to the Member States on 17 October 1984, harmonising the lead and cadmium limits and the test and analysis methods for ceramic articles intended to come into contact with foodstuffs.", "source": "https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31984L0500; https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520 · footnote 5 to Art. 4(1)" } ], "sources": [ { "label": "Council Directive 84/500/EEC on ceramic articles intended to come into contact with foodstuffs, consolidated text of 20 May 2005 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01984L0500-20050520" }, { "label": "Council Directive 84/500/EEC as published in OJ L 277, 20 October 1984 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31984L0500" }, { "label": "Document information, dates and relationships for CELEX 31984L0500 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31984L0500" }, { "label": "Commission Directive 2005/31/EC amending Directive 84/500/EEC as regards a declaration of compliance and performance criteria of the analytical method (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32005L0031" }, { "label": "Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food, consolidated text of 27 March 2021 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R1935-20210327" }, { "label": "Commission Regulation (EC) No 2023/2006 on good manufacturing practice for food contact materials (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006R2023" }, { "label": "Council Directive 89/109/EEC on materials and articles intended to come into contact with foodstuffs, repealing Directive 76/893/EEC (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31989L0109" }, { "label": "Regulation (EU) 2017/625 on official controls, repealing Regulation (EC) No 882/2004 (EUR-Lex)", "url": "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0625" }, { "label": "Food contact materials: legislation (European Commission, DG SANTE)", "url": "https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/legislation_en" }, { "label": "Revision of EU rules on food contact materials, including lead and cadmium from ceramic and vitreous materials (European Commission, DG SANTE)", "url": "https://food.ec.europa.eu/food-safety/chemical-safety/food-contact-materials/revision-eu-rules_en" }, { "label": "TRIS notification 2025/0387/DK, draft Danish order on food contact materials with lower lead and cadmium limits (European Commission)", "url": "https://technical-regulation-information-system.ec.europa.eu/en/notification/27084" }, { "label": "TRIS 2025/0387/DK, Denmark's response of 7 November 2025 on the legal basis of the ceramics, glass and enamel limits (European Commission)", "url": "https://technical-regulation-information-system.ec.europa.eu/en/notification/27084/message/113713/EN" }, { "label": "TRIS 2025/0387/DK, notified draft text in Danish (European Commission)", "url": "https://technical-regulation-information-system.ec.europa.eu/en/notification/27084/text/D/DA" }, { "label": "Bekendtgørelse nr. 681 af 25. maj 2020 om fødevarekontaktmaterialer og om straffebestemmelser for overtrædelse af relaterede EU-retsakter (Retsinformation)", "url": "https://www.retsinformation.dk/eli/lta/2020/681" }, { "label": "Keramik, materialetyper (Fødevarestyrelsen)", "url": "https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/materialetyper/keramik" }, { "label": "Køkkengrej og kemi i maden, herunder keramik, arvegods og loppefund (Fødevarestyrelsen)", "url": "https://foedevarestyrelsen.dk/kost-og-foedevarer/alt-om-mad/kemi-i-maden/koekkengrej" }, { "label": "Fødevarekontaktmaterialer, lovstof (Fødevarestyrelsen)", "url": "https://foedevarestyrelsen.dk/lovstof/foedevarekontaktmaterialer-lovstof" }, { "label": "Dokumentation for fødevarekontaktmaterialer (Fødevarestyrelsen)", "url": "https://foedevarestyrelsen.dk/kost-og-foedevarer/foedevaresikkerhed/emballage-og-udstyr/dokumentation" }, { "label": "Slutrapport: Metaller fra FKM af keramik, control project 2023 (Fødevarestyrelsen)", "url": "https://foedevarestyrelsen.dk/Media/638653560024818056/Slutrapport%20-%20Keramik%202023.pdf" } ], "reviewer": { "name": "Conphora compliance team", "role": "Compliance editors, Conphora" }, "reviewedAt": "2026-09-24", "nextReview": "2027-03-11", "links": { "tools": [], "courses": [], "related": { "en": "/regulations/cer/", "dk": "/dk/eu-regulativer/cer/" } } }