Annex XVII REACH: Restrictions on the Manufacture, Marketing, and Use of Chemical Substances

What is Annex XVII of REACH

Annex XVII is provided for in Title VIII of the REACH Regulation, in Articles 67 to 73. Article 67(1) establishes the fundamental principle: a substance, as such, as a component of a mixture, or contained in an article, for which Annex XVII provides a restriction, may not be manufactured, placed on the market, or used unless in compliance with the conditions of that restriction.

The restrictions in Annex XVII apply at European Union level and are mandatory for all Member States. Unlike authorization (Annex XIV), which focuses on SVHCs and their specific uses, the restrictions in Annex XVII may apply to any substance that poses an unacceptable risk to human health or the environment, regardless of whether it is classified as an SVHC.

Annex XVII inherited and expanded the restrictions already contained in Directive 76/769/EEC, integrating them into the REACH regulatory framework as of June 1, 2009. Today, it contains over 70 main entries, each of which may regulate a single substance, a group of substances, or entire chemical categories.

Structure of an Annex XVII entry

Each entry in Annex XVII is structured systematically, with common elements defining its scope and specific conditions:

• Identification of the substance — Chemical name, CAS number, EC/EINECS number. For groups of substances, definition of the criteria for membership (e.g., "substances classified as CMR category 1A or 1B").
• Restriction conditions — Detailed description of prohibitions or restrictions: maximum permissible concentrations, prohibited uses, sectors of application concerned, types of articles involved
• Derogations — Specific exemptions for certain uses, sectors, or circumstances. Derogations may be permanent or temporary
• Transitional periods — Differentiated entry into force dates to allow industry to adapt, with progressive deadlines for different stages of the supply chain
• Reference analytical methods — EN/ISO standards for verifying compliance (e.g., EN ISO 17234-1 for azo dyes)
• Labeling requirements — Additional marking, information, or documentation requirements

The Restriction Proposal Process

The introduction of a new restriction in Annex XVII follows a rigorous process defined in Articles 69-73 of REACH:

• Annex XV dossier — A Member State or ECHA (at the request of the Commission) prepares a restriction dossier in accordance with the format set out in Annex XV, containing hazard identification, risk assessment, analysis of alternatives, and socio-economic assessment
• Public consultation — The dossier is published on the ECHA website for a 6-month public consultation, during which interested parties can submit comments and data
• RAC opinion — ECHA's Risk Assessment Committee (RAC) issues a scientific opinion within 9 months of publication, assessing whether the proposed restriction is justified on the basis of the identified risks
• SEAC opinion — The Socio-Economic Analysis Committee (SEAC) issues an opinion on the proportionality of the restriction, considering the costs and benefits to industry and society, within 12 months
• Commission decision — The European Commission, based on the opinions of RAC and SEAC, prepares a proposal to amend Annex XVII, which is submitted to the REACH Committee for a vote (comitology procedure) and subsequently adopted as an amending regulation by the Commission

The entire process, from initial proposal to entry into force, typically takes 3-5 years, but can be accelerated for urgent risks.

The Main Restriction Entries in Annex XVII

Entries 28-30: CMR Substances for Consumer Use

Entries 28, 29, and 30 prohibit the placing on the market and use of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) in categories 1A and 1B in consumer substances and mixtures. These entries are dynamic: any update to Annex VI of the CLP (harmonized classification) may add new substances. The generic concentration limits are those of the CLP classification (e.g., 0.1% for Cat. 1A/1B carcinogens). Exemptions apply to medicines, cosmetics (regulated separately), fuels, and fuels in closed systems.

Entry 43: Azo dyes in textiles and leather

Entry 43 prohibits the use of azo dyes and pigments which, by reductive cleavage of one or more azo groups, may release one or more of the 22 carcinogenic aromatic amines listed in Appendix 8 of Annex XVII. The limit is 30 mg/kg (0.003%) for each aromatic amine in textiles and leather that may come into direct and prolonged contact with the skin. The reference analytical method is EN ISO 17234-1 (leather) and EN 14362-1/3 (textiles).

Entry 47: Chromium VI in Cement

Entry 47 limits the content of soluble chromium VI in cement and cement-containing mixtures to a maximum of 2 mg/kg (0.0002%) of the dry weight of the cement. The restriction applies to cement intended to be mixed with water before use. Chromium VI is a potent skin sensitizer and carcinogen, and exposure to wet cement is a leading cause of contact dermatitis in construction workers.

Entry 50: Polycyclic Aromatic Hydrocarbons (PAHs) in Extender Oils

Entry 50 restricts the content of PAHs (Polycyclic Aromatic Hydrocarbons) in extender oils used in the manufacture of tires and tire components. The limit is set at 1 mg/kg for Benzo[a]pyrene and 10 mg/kg for the sum of 8 specified PAHs. The restriction protects against chronic exposure to carcinogenic PAHs resulting from tire abrasion.

Entry 51: Phthalates (DEHP, DBP, BBP, DIBP) in Articles

Entry 51 prohibits the placing on the market of articles containing DEHP, DBP, BBP, and DIBP (individually or in combination) in concentrations exceeding 0.1% w/w of the plasticized material. This restriction, which was expanded in 2018, applies to all articles (no longer just toys) and covers the four phthalates classified as toxic to reproduction. The phthalates DINP, DIDP, and DNOP remain limited to 0.1% only in toys and childcare articles that can be placed in the mouth.

Item 63: Lead and its Compounds

Entry 63 restricts lead and its compounds in multiple categories of articles. For jewelry, the limit is 0.05% w/w in the individual component. The entry has been progressively expanded to cover wetland hunting pellets, articles intended to come into contact with children's mouths, and PVC materials. Each subparagraph has different application dates.

Entry 68: PFOA, PFOS, and PFAS Family

Entry 68, adopted in 2017 with Reg. (EU) 2017/1000 and applicable from July 4, 2020, restricts perfluorooctanoic acid (PFOA), its salts, and related substances. The limits are 25 ppb for PFOA and 1000 ppb for PFOA-related substances. In combination with the POP Regulation (EU) 2019/1021 covering PFOS, and the proposed universal restriction of PFAS currently under evaluation by ECHA (the largest restriction proposal in the history of REACH, involving over 10,000 substances), these restrictions represent one of the most significant compliance challenges for industry.

Entry 74: Diisocyanates — Training Requirement

Entry 74, which came into force in August 2023, introduces an innovative approach: it does not ban diisocyanates, but imposes a training obligation on all industrial and professional users who handle substances or mixtures containing diisocyanates in concentrations ≥ 0.1% w/w. The training must cover the chemistry of diisocyanates, health hazards (asthma, respiratory sensitization), protective measures, and emergency management. Suppliers must include the statement "As of [date], adequate training is required before industrial or professional use" on the label.

Entry 77: Formaldehyde in Articles

Entry 77 restricts the release of formaldehyde from articles to a maximum of 0.062 mg/m³ (concentration in the test chamber after 28 days). Formaldehyde, classified as a Category 1B carcinogen, is widely used in resins, wood panels, textiles, and cosmetics. The restriction applies to furniture, wood articles, road vehicles, and other articles that may emit formaldehyde into indoor air. Exemptions apply to articles used exclusively outdoors or in industrial environments with adequate ventilation.

Entry 78: Intentionally Added Microplastics

Entry 78, adopted in September 2023, prohibits the intentional addition of microplastics in products placed on the EU market. Microplastics are defined as synthetic polymer particles smaller than 5 mm, insoluble and resistant to degradation. The restriction provides for staggered transition periods: an immediate ban on cosmetics containing rinse-off microplastics (glitter, microbeads), while for other sectors (filling materials for sports surfaces, fertilizers, plant protection products) the transition periods extend until 2035. The impact affects cosmetics, detergents, agriculture, sports, and many other sectors.

Item 71: NMP and DMF — Occupational Exposure Limits

Entry 71 introduces restrictions on the use of N-methylpyrrolidone (NMP) and dimethylformamide (DMF), two solvents widely used in industry, setting derived no-effect levels (DNELs) that translate into occupational exposure limit values. For NMP, the DNEL for inhalation is 14.4 mg/m³; for DMF, the DNEL is 6 mg/m³. User companies must demonstrate that the conditions of use ensure compliance with these limits, documenting this in the chemical safety report.

Concentration Limits, Analytical Methods, and Testing Requirements

The restrictions in Annex XVII specify concentration limits that vary greatly depending on the substance and application, from values in percent (phthalates at 0.1%) to values in ppb (PFOA at 25 ppb). For each restriction, Annex XVII may indicate:

• Standardized analytical methods — EN or ISO standards for determining compliance (e.g., EN 16711-1 for lead in jewelry, EN ISO 17234-1 for aromatic amines in leather)
• Test conditions — Temperature, humidity, exposure time for migration or emission tests (e.g., test chamber at 23°C/50% RH for formaldehyde)
• Sampling — Sampling procedures and sample preparation, batch size, acceptance/rejection criteria
• Test frequency — Although Annex XVII does not generally impose a test frequency, Member State enforcement authorities may require it

kemXpro integrates all Annex XVII concentration limits into its screening engine, automatically comparing the composition of formulations with the applicable threshold values and reporting any exceedances or close approaches to the limits.

Enforcement and Sanctions in Member States

The enforcement of Annex XVII restrictions is the responsibility of each Member State, through its competent authorities and national penalty systems. This results in significant variability in penalties:

• Italy — Legislative Decree 186/2011 provides for administrative fines ranging from €10,000 to €60,000 per violation, with the possibility of criminal penalties for serious violations.
• Germany — ChemVerbotsV and ChemG provide for penalties of up to €50,000, with the possibility of imprisonment for intentional violations
• France — The Code de l'Environnement provides for penalties of up to €75,000 and two years' imprisonment for the most serious violations
• Spain — Real Decreto 1802/2008 provides for penalties ranging from €6,001 to €600,000 for serious infringements

The authorities may order the withdrawal from the market, seizure of products, and suspension of activities. The EU's RAPEX/Safety Gate system regularly publishes reports of products that do not comply with the restrictions in Annex XVII.

kemXpro and Annex XVII Compliance

kemXpro offers a comprehensive system for managing compliance with the restrictions of Annex XVII:

Automatic Screening of Formulations

Each formulation entered into the system is automatically compared with all applicable Annex XVII entries. The screening engine verifies the quantitative composition of the formulation against the concentration limits of each relevant entry, taking into account exemptions and specific conditions of application. The system flags not only non-compliance, but also situations where the limits are close to being exceeded, allowing for preventive action.

Alerts on New and Modified Restrictions

kemXpro continuously monitors ECHA's regulatory activities relating to Annex XVII: new restriction proposals (Annex XV dossiers), public consultations, RAC and SEAC opinions, adoption of new entries. When a new restriction or a modification of an existing restriction is adopted, the system automatically screens the entire product portfolio and generates specific alerts for the products affected.

Compliance Documentation Generation

kemXpro automatically generates documentation of compliance with Annex XVII restrictions, including declarations of compliance, screening reports, and supporting documentation for audits and inspections. Full traceability of compliance analyses allows you to demonstrate regulatory due diligence to the competent authorities.

Integration with CLP and SDS

Annex XVII restrictions have a direct impact on CLP classification and the content of Safety Data Sheets (SDS):

• Section 15 of the SDS — Applicable restrictions must be reported in the "Regulatory Information" section of the SDS, with reference to the Annex XVII entry and specific conditions.
• Supplementary labeling — Some Annex XVII entries require specific labeling (e.g., entry 72 on diisocyanates), in addition to standard CLP labels
• Exposure scenarios — Restriction conditions may affect the exposure scenarios attached to the extended SDS, particularly for high-tonnage registered substances
• Harmonized classification — Entries 28-30 (CMR substances) are directly linked to Annex VI of the CLP: any update to the harmonized classification may extend the list of substances subject to restriction for consumer use

kemXpro manages these interconnections in an integrated manner, automatically updating SDSs and labeling documentation when an Annex XVII restriction affects a product in the database.