REACH testing requirements for chemicals and products

updated 

Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) requires chemical manufacturers and importers to register their substances with the European Chemicals Agency (ECHA) and to provide sufficient information to downstream users to facilitate safe use and disposal.1 REACH also restricts the use of hazardous chemicals in products and materials, making it relevant to most companies operating in the EU.

This article outlines key testing requirements and test methods for REACH compliance, covering substance identification and characterization, as well as screening of articles for restricted and hazardous substances.

Substance identification and characterization for REACH registration

All manufacturers and importers that produce or bring to market at least one tonne of a chemical annually must register the substance with ECHA and provide the agency with a technical dossier on its identity and properties. The information requirements, which are outlined in detail in Annexes VI to XI to REACH, include:

  • Substance identifiers (e.g., IUPAC name, CAS and EC numbers, molecular formula)

  • Composition and degree of purity, including typical concentrations of known impurities and additives

  • Sufficient qualitative and quantitative analytical data for substance identification

  • Additional characterization data on any nanoforms of the substance, covering properties such as particle size distribution, morphology, and specific surface area

  • Information on the physicochemical, toxicological, and ecotoxicological properties of the substance

  • Classifications and labels applicable to the substance under the CLP Regulation (EC) No 1272/20082

  • Guidance on safe use and disposal

A chemical safety assessment, covering potential human health, physicochemical, and environmental hazards, is also required for substances manufactured or imported in quantities of 10 tonnes or more per year.

Analytical methods for substance identification

The extent of analytical data required for substance identification under REACH depends on the complexity of the substance.3 For organic substances with well-defined composition, characterization with two or three spectroscopic methods and one chromatographic method from the following list is typically sufficient:

  • Ultraviolet and visible absorption spectroscopy (UV/Vis)

  • Infrared spectroscopy (IR)

  • Nuclear magnetic resonance spectroscopy (NMR)

  • Mass spectrometry (MS) 

  • Gas chromatography (GC)

  • High-performance liquid chromatography (HPLC)

For inorganic substances, identification is instead based on methods selected from the following list:

  • X-ray diffraction (XRD)

  • X-ray fluorescence (XRF)

  • Atomic absorption spectroscopy (AAS)

  • Inductively coupled plasma-optical emission spectroscopy (ICP-OES) or mass spectrometry (ICP-MS)

A larger number of tests is generally required to confirm the identity of UVCB substances (i.e., substances of unknown or variable composition, complex reaction products, or biological materials), which cannot be defined by their chemical composition alone. For example, confirming the identity of biochar requires CHNO analysis, determination of volatiles, moisture, and ash content, elemental analysis with XRF, structural analysis with XRD, and further screening of volatile organic contaminants.4

Analytical methods for physicochemical, toxicological, and ecotoxicological characterization

REACH information requirements regarding the physicochemical, toxicological, and ecotoxicological properties of the substance depend on annual tonnage. While information on all three is required even for substances manufactured or imported in quantities of one tonne or more, more complex studies are required in the higher tonnage ranges.

Selected analyses that can be used to obtain the required information are listed in Table 1. All the listed tests are recognized under Regulation (EC) No 440/20085 on REACH test methods, and are available through Measurlabs. It is worth noting that conducting new tests may not be necessary if existing data on the substance or structurally related substances are sufficient to establish its properties.6

Table 1: Selected REACH test methods for substance property and hazard characterization

Property

Test category

Test method(s)*

Flammability

Physicochemical

EN 15188: Spontaneous ignition behavior of dust accumulations

Flash point

Physicochemical

EN ISO 2719: Pensky-Martens closed cup method

Relative density

Physicochemical

ISO 12154: Skeleton density by gas pycnometry

Water solubility

Physicochemical

OECD 105: Water solubility 

Skin corrosion/irritation

Toxicological

OECD 431: In vitro skin corrosion with a reconstructed human epidermis (RhE) model

Serious eye damage/irritation

Toxicological

OECD 492: In vitro test with a reconstructed human cornea-like epithelium (RhCE)

OECD 437: Bovine corneal opacity and permeability (BCOP) test

OECD 438: Isolated chicken eye test

Skin sensitization

Toxicological

OECD 442C: Direct peptide reactivity assay (DPRA)

OECD 442D: ARE-Nrf2 luciferase assay

OECD 442E: Human cell line activation test (h-CLAT) 

Mutagenicity

Toxicological

OECD 471: Bacterial reverse mutation test (Ames)

Aquatic toxicity

Ecotoxicological

OECD 201: Freshwater alga and cyanobacteria growth inhibition test

OECD 202: Daphnia sp. acute immobilization test

OECD 209: Activated sludge respiration inhibition test

Degradation

Ecotoxicological

OECD 301: Ready biodegradability

OECD 306: Biodegradability in seawater

* The method list is not comprehensive in all cases; see Regulation (EC) No 440/2008 for the full list of methods for evaluating each property.

Substances of very high concern (SVHC) and substances subject to authorization

Any EU member state, or ECHA at the European Commission’s request, can propose a substance to be included in the candidate list of substances of very high concern (SVHC) if it has one or more of the following hazardous properties:

  • Carcinogenic, mutagenic, or toxic to reproduction (CMR, categories 1A and 1B) 

  • Persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB)

  • Other properties that cause an equivalent level of concern

ECHA assesses substances on the SVHC list in a prioritized order and drafts recommendations for their inclusion in the REACH Annex XIV authorization list. Substances on this list can only be used or placed on the market subject to authorization by the Commission.

Identification as an SVHC already introduces several legal obligations for companies using the substance, including informing customers and consumers about safe use.7 To determine whether these obligations apply, companies can have their chemical or material screened for the full list of SVHCs. The obligations are triggered if any listed substance is found in concentrations above 0.1% by weight of the article.

REACH Annex XVII: Restricted substances

Annex XVII to REACH specifies over 80 restrictions on the manufacture, use, and placing on the market of dangerous substances and mixtures on their own or in specific articles. The conditions of each restriction are specified in the applicable entry, covering details such as applicable product groups, possible derogation periods, and maximum concentration or release limits.

The violation of a REACH Annex XVII entry is a common reason for products being found non-compliant during market surveillance, resulting in several hundred market withdrawals and recalls each year.8 Table 2 summarizes selected Annex XVII entries that are regularly used as the legal basis for market withdrawals in the EU, along with several recent high-profile entries.

Table 2: Selected substances and substance groups restricted under REACH Annex XVII

Annex XVII entry

Substance/substance group

Applicable products*

Max. concentration or release limit

6

Asbestos fibers (crocidolite, amosite, anthophyllite, actinolite, tremolite, chrysotile)

All mixtures and articles (high-risk products include sand-based toys and motor vehicle brake pads)

No limit specified; qualitative identification is sufficient to deem the material non-compliant

23

Cadmium and its compounds

Plastic materials

Metallic jewelry and accessories

Paints

0.01% by weight in plastic materials, jewelry, and most paints

0.1% by weight in paints with >10% zinc content

27

Nickel and its compounds

Jewelry and other articles that come into contact with the skin

0.2 µg/cm2/week for nickel migration from first-time piercings

0.5 µg/cm2/week for migration from other articles

50

Polycyclic aromatic hydrocarbons (PAH)**

Extender oils for tire production

Articles that come into contact with the skin or the mouth (e.g., clothing, sports equipment)

Toys

Granules or mulches for playgrounds and sports fields

1 mg/kg for benzo[a]pyrene and 10 mg/kg for the sum of PAHs in extender oils

1 mg/kg for any single PAH in plastic/rubber parts of skin-contacting articles

0.5 mg/kg for any single PAH in plastic/rubber parts of toys

20 mg/kg for the sum of PAHs in granules or mulches

51

Phthalates (DEHP, DBP, BBP, DIBP)

Most consumer articles with plasticized material

0.1% by weight of plasticized material

52 

Phthalates (DINP, DIDP, DNOP)

Toys and childcare articles that can be placed in the mouth

0.1% by weight of plasticized material

63

Lead and its compounds

Jewelry

Articles that may be placed in the mouth by children

PVC articles

0.05% by weight in jewelry and articles that may be placed in the mouth

0.1% by weight in PVC materials

68

C9-C14 PFCAs and related substances (a subset of PFAS)

Most mixtures and articles

25 ppb for the sum of C9-C14 PFCAs and 260 ppb for the sum of related substances

77

Formaldehyde and formaldehyde-releasing substances

Furniture and wood-based articles

Other articles for indoor use

Road vehicle interiors

0.062 mg/m3 for release from furniture and wood-based articles

0.080 mg/m3 for release from other articles

0.062 mg/m3 for release from road vehicle interiors (from 6 August 2027)

78

Synthetic polymer microparticles (i.e., microplastics)

Microplastics on their own or as intentional constituents of consumer products and mixtures***

0.01% by weight

82

Per- and polyfluoroalkyl substances (PFAS)

Firefighting foams****

1 mg/l for the sum of PFAS (from 23 October 2030)

* The product list is not comprehensive in all cases; see REACH Annex XVII for the full description of each restriction.

** The PAHs restricted under entry 50 are benzo[a]pyrene, benzo[e]pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[j]fluoranthene, benzo[k]fluoranthene, and dibenzo[a,h]anthracene. Additional PAH restrictions are specified in entry 50a (18 PAHs in clay targets for shooting).

*** Derogation periods apply to several product groups, including cosmetics, fertilizing products, and detergents. Water-soluble and biodegradable polymers are exempted.

**** A proposal for a blanket PFAS restriction applicable to all product groups (with sector-specific derogation periods) is currently in progress.9

In addition to substance- and substance group-specific restrictions such as those outlined in Table 2, Annex XVII contains several entries that restrict the use of a wide range of chemicals in specific product groups. These include entry 72, which sets limits for the concentration of over 30 chemicals in textiles and footwear, and entry 75, which restricts the use of carcinogenic, reprotoxic, sensitizing, and corrosive substances in tattoo inks.

Compliance with Annex XVII limits is evaluated through laboratory testing, using methods selected based on target analytes, required detection limit, and limit type (concentration, migration, release into air). Examples of commonly applied test methods include ICP-MS for heavy metals and GC-MS for PAHs and phthalates, either in the material itself or its extract. Release into air can be measured using chamber methods, such as EN 717-1 for formaldehyde release from wood-based panels.

Our REACH testing services

Measurlabs offers a broad range of analytical services to support substance identification, hazard characterization, and restricted substance screening for REACH compliance. The following are some examples from our service catalog:

The list above is not exhaustive. Use the form below to talk to our experts about any testing requirements related to the REACH Regulation, and we will get back to you in one business day.

References:

1 Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (consolidated text from 22/06/2026)

2 Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (consolidated text from 01/07/2026)

3 See ECHA Guidance for identification and naming of substances under REACH and CLP (Version 3.0, December 2023) for details.

4 The substance identification requirements for REACH registration of biochar under the charcoal dossier (EC 240-383-3) are outlined in a presentation by the lead registrant Coalster GmbH.

5 Commission Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 (consolidated text from 08/01/2026)

6 The information requirements for different tonnage ranges are detailed in REACH Annexes VII to X. Existing information to be considered before new studies are conducted includes results from prior in vitro and in vivo tests, historical human data, and quantitative structure–activity relationship (QSAR) data.

7 See ECHA landing page for a summary of obligations resulting from inclusion of SVHCs in the Candidate List.

8 According to the European Commission’s Safety Gate rapid alert system for dangerous non-food products, non-compliance with the REACH Regulation has been the legal reason for more than 1,000 products being identified as dangerous since the beginning of 2024 (up until the end of August 2026).

9 See ECHA PFAS landing page for latest updates on the universal PFAS restriction proposal.

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