The counterintuitive reading of Commission Directive 2003/40/EC is not that it sets maximum concentrations for mineral constituents. That was the uncontroversial headline. What makes this instrument structurally significant is the mechanism: the Commission used Article 11(1) of Council Directive 80/777/EEC of 15 July 1980 to translate a Scientific Committee for Food opinion directly into a binding Annex of concentration limits, mandatory label wording set verbatim in the operative text, and a pre-notification regime for ozone treatment that functions as a prior authorisation system in all but name. Commission Directive 2003/40/EC, recitals (1)–(3); Council Directive 80/777/EEC, Art. 11(1) Published in Official Journal L 126 of 22 May 2003, it is the complete regulatory template governing natural mineral water marketing across the EU since 1 January 2004.
The Delegation Basis: Article 11(1) of Directive 80/777/EEC
The Commission acted on a specific mandate. Article 11(1) of Directive 80/777/EEC provided for adoption of harmonised concentration limits for mineral water constituents after consulting the Scientific Committee for Food, together with labelling requirements indicating the presence of certain constituents at high concentrations. Commission Directive 2003/40/EC, recital (2) That mandate is narrow: consult the Scientific Committee, adopt limits, prescribe labels. The implementing instrument had to remain within those rails.
Recital (3) records that the Scientific Committee for Food issued opinions on arsenic, barium, fluoride, boron, and manganese and validated the WHO's limits for other constituents. Commission Directive 2003/40/EC, recital (3) For remaining undesirable constituents, the revised Codex Alimentarius standard (Codex standard 108-1981, Rev 1-1997) provided the reference, adjusted where the Codex limit was considered too low. Commission Directive 2003/40/EC, recitals (4), (8) The Directive's Annex I is the output of that process.
Concentration Limits and Compliance Deadlines: Article 2 and Annex I
Article 2(1) sets the primary compliance obligation: by 1 January 2006 at the latest, natural mineral waters must, at the time of packaging, comply with the maximum concentration limits set out in Annex I for the constituents listed in that Annex. Commission Directive 2003/40/EC, Art. 2(1) The measurement point is packaging, not the source.
Article 2(2) carves out a differentiated deadline for two specific constituents: fluorides and nickel face an extended compliance deadline of 1 January 2008. Commission Directive 2003/40/EC, Art. 2(2) Recital (10) supplies the rationale: as of 2003, no separation treatment for fluorides or nickel had been assessed or authorised at Community level, meaning operators with excess concentrations had no approved technical remedy and needed additional time. Commission Directive 2003/40/EC, recital (10)
Article 2(3) preserves Member State competence within official recognition procedures only: competent authorities may apply a lower reference value for nitrates and nitrites during source recognition, provided it applies consistently to all applications. Commission Directive 2003/40/EC, Art. 2(3) This is a recognition-stage derogation, not a derogation from Annex I limits for market-ready products.
The Fluoride Labelling Regime: Articles 4(1) and 4(2)
The fluoride provisions illustrate how Directive 2003/40/EC converts a scientific committee opinion into mandatory operator behaviour. Recital (6) records that the WHO recommended a guide value of 1.5 mg/l for fluoride in drinking water, validated for natural mineral waters by the Scientific Committee for Food, on the basis that infants and young children are most sensitive to the risk of fluorosis. Commission Directive 2003/40/EC, recital (6)
Article 4(1) translates that scientific position into a specific, non-negotiable label obligation. Natural mineral waters with a fluoride concentration exceeding 1.5 mg/l must bear on the label the exact words: "contains more than 1,5 mg/l of fluoride: not suitable for regular consumption by infants and children under 7 years of age". Commission Directive 2003/40/EC, Art. 4(1) The Directive prescribes the text verbatim. An operator who paraphrases the substance without replicating the specified form does not comply with Article 4(1).
Article 4(2) adds a placement requirement: that label information must be placed in immediate proximity to the trade name and in clearly visible characters. Commission Directive 2003/40/EC, Art. 4(2) Proximity to the trade name is structural: the warning must be encountered alongside the brand identifier, not confined to a side or back panel.
The Ozone Treatment Regime: Articles 5 and 6
Article 4(1)(b) of Directive 80/777/EEC already authorised the separation of iron, manganese, sulphur, and arsenic using ozone-enriched air treatment, subject to Scientific Committee assessment and adoption of conditions by the Standing Committee on the Food Chain and Animal Health. Directive 2003/40/EC adopts those conditions.
The pre-notification requirement in Article 5(1) functions as a prior approval system. Application of ozone-enriched air treatment must be notified in advance to the competent authorities, who must ensure:
→ Use of the treatment is justified by the water's composition in terms of iron, manganese, sulphur, and arsenic compounds. Commission Directive 2003/40/EC, Art. 5(1)(a)
→ The operator has taken all measures necessary to guarantee the treatment is effective and safe and to allow verification by the competent authorities. Commission Directive 2003/40/EC, Art. 5(1)(b)
The authority must verify both justification and safeguards before treatment proceeds; notification without authority verification does not discharge Article 5(1).
Article 5(2) sets three cumulative substantive conditions governing the conduct of ozone treatment:
→ The physico-chemical composition of the natural mineral water in terms of essential constituents must not be modified by the treatment. Commission Directive 2003/40/EC, Art. 5(2)(a)
→ The water before treatment must already comply with the microbiological criteria in Article 5(1) and (2) of Directive 80/777/EEC; ozone treatment may not be used as a microbiological remedy. Commission Directive 2003/40/EC, Art. 5(2)(b)
→ The treatment must not lead to the formation of residues with a concentration exceeding the maximum limits in Annex III, or residues posing a risk to public health. Commission Directive 2003/40/EC, Art. 5(2)(c)
Recital (14) characterises the technique as a separation process only: ozone treatment may not alter characteristic constituents under Article 7(2)(a) of Directive 80/777/EEC, may not have a disinfectant action, and may not generate harmful treatment residues. Commission Directive 2003/40/EC, recital (14)
Article 6 imposes the disclosure obligation for treated waters. Pursuant to Article 7(2)(c) of Directive 80/777/EEC, labelling of ozone-treated natural mineral waters must bear, in proximity to the analytical composition of characteristic constituents, the exact words: "water subjected to an authorised ozone-enriched air oxidation technique". Commission Directive 2003/40/EC, Art. 6 The text is verbatim; placement in proximity to the analytical composition ensures the disclosure is encountered alongside the compositional data.
Article 7 extends Articles 5 and 6 to spring waters, pursuant to Article 9(4)(a) fourth indent of Directive 80/777/EEC. Commission Directive 2003/40/EC, Art. 7
Transitional Provisions: Article 8
Article 8 structures the transition across three stages:
→ Member States were required to permit marketing of compliant products by 1 January 2004. Commission Directive 2003/40/EC, Art. 8(1)
→ Without prejudice to the Article 2 deadlines, Member States were required to prohibit marketing of non-compliant products from 1 July 2004. Commission Directive 2003/40/EC, Art. 8(2)
→ Products packaged and labelled prior to 1 July 2004 may be sold until stocks are exhausted. Commission Directive 2003/40/EC, Art. 8(2)
The concentration deadlines under Article 2 and the marketing prohibition under Article 8(2) run in parallel. The Article 2 deadlines govern when concentration non-compliance becomes a marketing offence: 1 January 2006 generally, 1 January 2008 for fluorides and nickel. The already-packaged product concession covers only stock packaged and labelled before 1 July 2004 and does not authorise continued production after that date.
Every answer carries its citation. Primary sources, not summaries. Compliance assessments touching constituent concentrations, fluoride labelling, or ozone treatment authorisations under Directive 2003/40/EC require the implementing Directive and the parent Directive 80/777/EEC. Research across the Union, settled in seconds, at omnilaw.ai.
FAQ
Does Directive 2003/40/EC apply to all bottled waters or only natural mineral waters?
The Annex I concentration limits apply to natural mineral waters. The ozone treatment conditions in Articles 5 and 6 extend to spring waters by virtue of Article 7, applying those provisions pursuant to Article 9(4)(a) fourth indent of Directive 80/777/EEC. Commission Directive 2003/40/EC, Arts. 1, 7 Ordinary bottled water outside both definitions is not within scope.
If a water's fluoride concentration is between 1.0 and 1.5 mg/l, is the Article 4(1) warning label required?
No. The Article 4(1) obligation arises only where the fluoride concentration exceeds 1.5 mg/l, the WHO guide value validated by the Scientific Committee for Food and recorded in recital (6). Commission Directive 2003/40/EC, Art. 4(1); recital (6) A concentration at or below that threshold triggers no Article 4 labelling requirement, though the Annex I maximum limit for fluorides still applies after 1 January 2008.
Can a producer notify competent authorities of intended ozone treatment and proceed immediately?
No. Article 5(1) requires advance notification, but the competent authorities must "ensure" that the treatment is justified by the water's composition and that the operator has effective safeguards in place before treatment is applied. Commission Directive 2003/40/EC, Art. 5(1)(a)–(b) Authority verification is a prerequisite, not a post-hoc review. Proceeding before the competent authority has satisfied itself on both conditions does not discharge Article 5(1).
What is the relationship between the Article 2 concentration deadlines and the Article 8(2) marketing prohibition?
They run in parallel. The Article 8(2) prohibition from 1 July 2004 catches products "not complying with the present Directive." For concentration non-compliance, the Article 2 deadlines govern: 1 January 2006 generally, 1 January 2008 for fluorides and nickel. The already-packaged product concession permits sale of stock packaged and labelled before 1 July 2004 until stocks are exhausted; continued production after that date is not covered. Commission Directive 2003/40/EC, Arts. 2(1)–(2), 8(2)
