CER in plain terms
The Ceramics Directive, formally Council Directive 84/500/EEC, is the EU’s specific measure for one material and two hazards: lead and cadmium migrating from ceramic articles into food. It concerns the possible migration of lead and cadmium from 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)). Rather than a general safety principle, it gives measurable limits per category of article, a single migration test in 4 % acetic acid, and performance criteria for the analysis (Art. 2 and Annexes I and II). Since Commission Directive 2005/31/EC it also requires a written declaration of compliance and supporting test documentation for the authorities (Art. 2a and Annex III).
As a directive it works through national law. It was notified to the Member States on 17 October 1984; three years later trade in compliant articles had to be permitted and five years later, from 17 October 1989, the placing on the market of non-compliant articles had to be prohibited (Art. 5). The 2005 amendment had to be transposed by 20 May 2006, with manufacture and import of non-compliant articles prohibited from 20 May 2007 (Directive 2005/31/EC, Art. 2).
Official text Read the directive on EUR-Lex: Council Directive 84/500/EEC (CELEX 31984L0500), or the consolidated text of 20 May 2005 that includes the declaration of compliance and the updated analytical criteria of Directive 2005/31/EC.
Scope
Ceramic articles are articles 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; they are first shaped and the shape is permanently fixed by firing, and they may be glazed, enamelled and/or decorated (Art. 1(3)). Stoneware, earthenware, porcelain and bone china plates, mugs, bowls, jugs, casseroles and storage jars are the typical cases. Glass and enamelled metal are not ceramic articles: they are separate material groups in Annex I to Regulation (EC) No 1935/2004 without an EU specific measure, so national rules under Article 6 of that regulation govern them (Regulation (EC) No 1935/2004, Art. 6 and Annex I). Decorative ceramics not intended for food are outside the directive, and the declaration of compliance was introduced precisely to distinguish food contact ceramics from decorative articles (Directive 2005/31/EC, recital 3). Materials and articles supplied as antiques are outside the framework regulation altogether (Regulation (EC) No 1935/2004, Art. 1(3)(a)).
Article 1(1) still describes the directive as 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 to be construed as references to Directive 89/109/EEC (Art. 10); Regulation (EC) No 1935/2004 then repealed Directive 89/109/EEC and provided that references to the repealed directives are to be construed as references to the regulation (Art. 26). The reference in Article 1(1) is therefore read as a reference to Regulation (EC) No 1935/2004, and Directive 2005/31/EC accordingly calls the ceramics directive a specific measure within the meaning of Article 5 of that regulation (recital 1). The practical consequence is that the framework’s general requirements, labelling, declaration, traceability, controls and sanctions apply to ceramic articles on top of the lead and cadmium limits, and that ceramics manufacturers must work under the good manufacturing practice rules of Regulation (EC) No 2023/2006, which apply since 1 August 2008 (Art. 8).
The duties fall on the manufacturer of the finished article, on the seller established within the Union that may issue the declaration, and on the importer into the Union, which must hold the test documentation (Art. 2a and Annex III, point 1); distributors and retailers must see that the declaration accompanies the goods, since it is required at all marketing stages up to and including the retail stage (Art. 2a(1)).
What you must do
The limits
The quantities of lead and cadmium transferred from ceramic articles shall not exceed the limits laid down in Article 2(4), which sorts articles into three categories by shape and capacity. Category 1 covers articles which cannot be filled and articles which can be filled but whose internal depth, measured from the lowest point to the horizontal plane passing through the upper rim, does not exceed 25 mm: 0,8 mg/dm² lead and 0,07 mg/dm² cadmium. Category 2 covers all other articles which can be filled: 4,0 mg/l lead and 0,3 mg/l cadmium. Category 3 covers cooking ware and packaging and storage vessels having a capacity of more than three litres: 1,5 mg/l lead and 0,1 mg/l cadmium (Art. 2(1) and 2(4)).
Where a ceramic article consists of a vessel fitted with a ceramic lid, the limit that may not be exceeded 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 sum of the two extraction levels is related to the surface area or the volume of the vessel alone (Art. 2(3)). An article that exceeds a limit by no more than 50 % is nevertheless recognised as compliant if at least three other articles with the same shape, dimensions, decoration and glaze are tested and the average does not exceed the limit, with none of them exceeding it by more than 50 % (Art. 2(5)).
Article 4(1)(a) required the Council to determine, within three years of notification, limitations for those areas of ceramic articles with which the mouth is intended to come into contact, and Article 4(2) required the Commission to re-examine the limits with a view to reducing them. Neither a rim limit nor reduced limits appear in the consolidated text of 20 May 2005; the rim question has been answered nationally in Denmark (see Enforcement and penalties).
The migration test
Migration is determined by the test in Annex I using a method of analysis meeting Annex II (Art. 2(2)). The simulant is 4 % (v/v) acetic acid in a freshly prepared aqueous solution, and the test runs at 22 ± 2 °C for 24 ± 0,5 hours (Annex I, points 1 and 2.1). When lead is determined the sample is covered by an appropriate means of protection and exposed to the usual lighting conditions of a laboratory; when cadmium, or lead and cadmium, are determined the sample is covered so that the surface tested is kept in total darkness (Annex I, point 2.2). Fillable articles are filled to a level no more than 1 mm from the overflow point, or no more than 6 mm measured along a flat or slightly sloping rim; articles that cannot be filled have the non-contact surface covered with a protective layer resistant to the acid and are then immersed so that the food contact surface is completely covered (Annex I, point 3). The surface area of a category 1 article is the area of the meniscus formed by the free liquid surface when filled as prescribed (Annex I, point 4).
Annex II, as replaced by Directive 2005/31/EC, no longer prescribes a single technique: any instrumental method may be used that meets its performance criteria, namely detection limits of at most 0,1 mg/l for lead and 0,01 mg/l for cadmium, quantification limits of at most 0,2 mg/l and 0,02 mg/l, recovery of added lead and cadmium within 80 to 120 %, and freedom from matrix and spectral interference (Annex II, point 4). The sample must be clean and free from grease, washed in a household liquid detergent solution at about 40 °C, rinsed in tap water and then distilled water, drained and dried, and not handled on the test surface afterwards; a blank is run on the reagent for each series of determinations (Annex II, point 5).
Declaration of compliance and documentation
At the marketing stages up to and including the retail stage, ceramic articles which are not yet in contact with foodstuffs must be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004, issued by the manufacturer or by a seller established within the Community (Art. 2a(1)). Annex III lists its content: the identity and address of the company which manufactures the finished ceramic article and of the importer who imports it into the Community; the identity of the ceramic article; the date of the declaration; and the confirmation that the article meets the relevant requirements of the directive and of Regulation (EC) No 1935/2004. The declaration must permit easy identification of the goods for which it is issued and must be renewed when substantial changes in production bring about changes in the migration of lead and cadmium (Annex III).
Behind the declaration sits the evidence. Appropriate documentation demonstrating that the articles comply with the migration limits must be made available by the manufacturer or the importer into the Community to the national competent authorities on request, and it must contain the results of the analysis carried out, the test conditions and the name and address of the laboratory that performed the testing (Art. 2a(2)).
Framework duties
Because the directive is a specific measure under Regulation (EC) No 1935/2004, every business operator in the chain must also ensure that ceramic articles are manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not 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 organoleptic characteristics, and that their labelling, advertising and presentation do not mislead consumers (Art. 3). Articles not yet in contact with food must carry the words for food contact, a specific indication of use or the Annex II symbol unless they are clearly intended for food contact, any special instructions for safe use, the name or trade name and address of the manufacturer, processor or seller responsible for placing on the market established within the Community, and the identification that ensures traceability (Art. 15). Retail trade is prohibited if the use information is not given in a language easily understood by purchasers (Art. 15(4)). Business operators must have systems that identify the businesses from which and to which articles were supplied (Art. 17(2)), and manufacturers must run documented quality assurance and quality control systems with records available to the authorities (Regulation (EC) No 2023/2006, Art. 4 to Art. 7).
Obligations by role
Manufacturers keep migration within the category limits, test under Annex I with an Annex II-conforming method, issue the declaration of compliance and hold the test documentation (Art. 2, Art. 2a and Annex III). Importers make sure the declaration names them and accompanies the goods, hold the same documentation for the authorities and label the articles with their name and address as the seller responsible for placing on the market (Art. 2a and Annex III; Regulation (EC) No 1935/2004, Art. 15(1)(c)). Distributors and retailers sell only ceramics accompanied by the declaration, display the labelling information at retail and keep traceability records (Art. 2a(1); Regulation (EC) No 1935/2004, Art. 15(7) and Art. 17(2)).
What is changing
The Commission states on its revision page that current exposure to lead and cadmium may be of concern, that those metals are sometimes released in significant amounts from both 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 from ceramic and vitreous food contact materials, with tailored transition plans, supply chain controls and conditional derogations discussed for artisanal and traditional producers. No amending act has been adopted; the consolidated text remains that of 20 May 2005.
Denmark has moved first. On 17 July 2025 the Commission received TRIS notification 2025/0387/DK of a draft order that 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 per litre, with articles lawfully marketed before that date sold until stocks are exhausted (draft, § 10 and § 16). Denmark told the Commission that the ceramics limits are a safeguard measure under Article 18 of Regulation (EC) No 1935/2004 and the glass and enamel limits national measures under 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 of 25 May 2020 as the order in force, so the limits below remain the applicable Danish law.
Enforcement and penalties
The directive has no penalty article of its own. Member States had to amend their national laws so that trade in compliant 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 (Art. 5). Enforcement and sanctions come from the framework: Member States carry out official controls under the Union rules on official food and feed controls (Regulation (EC) No 1935/2004, Art. 24; Article 24(3) still cites Regulation (EC) No 882/2004, which Regulation (EU) 2017/625 repealed with effect from 14 December 2019, so the reference is read as a reference to Regulation (EU) 2017/625 in accordance with its Article 146(2) and the correlation tables in its Annex V), lay down effective, proportionate and dissuasive sanctions (Art. 25) 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 (Art. 18).
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, and has been in force since 1 July 2020 (§ 25); § 7 makes Fødevarestyrelsen the authority to be notified when a business withdraws non-compliant materials. The order implements the directive as amended (footnote 1). Its § 14 and bilag 4 apply the directive’s limits, 0,8 mg/dm² lead and 0,07 mg/dm² cadmium for category I, 4,0 mg/l and 0,3 mg/l for category II and 1,5 mg/l and 0,1 mg/l for category III, to ceramic and enamelled articles and glassware alike, and add a category I limit for the mouth rim of drinking vessels, tested on a 2 cm band along the upper edge inside and outside; mugs and similar drinking vessels must meet both the rim limit and the category II limit (bilag 4, note 2, and bilag 6, part A, points 2.3 and 4). The 50 % tolerance with three further articles is carried over in § 14(2). The ceramics declaration of compliance 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 (§ 15 and bilag 5, point 4). A business, producer or importer that has reason to believe its food contact materials do not meet the safety requirements must withdraw them, notify Fødevarestyrelsen immediately and inform or recall from consumers (§ 7). Infringements of §§ 6 to 12 and 14 to 15, 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 are punished with a fine, rising 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; companies can be held criminally liable (§ 17, § 18 and § 19). Fødevarestyrelsen’s ceramics page recommends that producers use glazes without lead and cadmium, and its 2023 control project tested 47 ceramic, porcelain and enamelled articles from Danish producers, importers and wholesalers without finding an exceedance of the limits.
How Conphora helps
Conphora monitors the Ceramics Directive, the framework regulation and the Danish order and maps your ceramic articles against the category limits, flagging missing migration tests, wrong category classification, gaps in the declaration of compliance and the test documentation, and articles that would fail the lower limits in the notified Danish draft before they become enforcement problems. The platform keeps the declarations, laboratory reports and traceability records in one place and alerts you when the EU limits or the Danish order change.
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Sources
- Council Directive 84/500/EEC on ceramic articles intended to come into contact with foodstuffs, consolidated text of 20 May 2005 (EUR-Lex)
- Council Directive 84/500/EEC as published in OJ L 277, 20 October 1984 (EUR-Lex)
- Document information, dates and relationships for CELEX 31984L0500 (EUR-Lex)
- 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)
- Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food, consolidated text of 27 March 2021 (EUR-Lex)
- Commission Regulation (EC) No 2023/2006 on good manufacturing practice for food contact materials (EUR-Lex)
- Council Directive 89/109/EEC on materials and articles intended to come into contact with foodstuffs, repealing Directive 76/893/EEC (EUR-Lex)
- Regulation (EU) 2017/625 on official controls, repealing Regulation (EC) No 882/2004 (EUR-Lex)
- Food contact materials: legislation (European Commission, DG SANTE)
- Revision of EU rules on food contact materials (European Commission, DG SANTE)
- TRIS notification 2025/0387/DK, draft Danish order on food contact materials (European Commission)
- TRIS 2025/0387/DK, Denmark’s response of 7 November 2025 (European Commission)
- TRIS 2025/0387/DK, notified draft text in Danish (European Commission)
- Bekendtgørelse nr. 681 af 25. maj 2020 om fødevarekontaktmaterialer og om straffebestemmelser for overtrædelse af relaterede EU-retsakter (Retsinformation)
- Keramik, materialetyper (Fødevarestyrelsen)
- Køkkengrej og kemi i maden, herunder keramik, arvegods og loppefund (Fødevarestyrelsen)
- Fødevarekontaktmaterialer, lovstof (Fødevarestyrelsen)
- Dokumentation for fødevarekontaktmaterialer (Fødevarestyrelsen)
- Slutrapport: Metaller fra FKM af keramik, control project 2023 (Fødevarestyrelsen)
This guide is for general information and is not legal advice.