Source

Commission Regulation (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation and acute toxicity (Text with EEA relevance)

Regulation (EU) 2016/863 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

Open ↗

Annexes VII and VIII to Regulation (EC) No 1907/2006 are amended in accordance with the Annex to this Regulation.

Article 2

Open ↗

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

Open ↗

ANNEX Annexes VII and VIII to Regulation (EC) No 1907/2006 are amended as follows: (1) points 8.1 and 8.2 of Annex VII shall be replaced by the following: ‘8.1. Skin corrosion/irritation 8.1. The study/ies do(es) not need to be conducted if: — the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as skin corrosion (Category 1), or — the substance is spontaneously flammable in air or in contact with water or moisture at room temperature, or — the substance is classified as acute toxicity by the dermal route (Category 1), or — an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2 000 mg/kg body weight). If results from one of the two studies under point 8.1.1 or 8.1.2 already allow a conclusive decision on the classification of a substance or on the absence of skin irritation potential, the second study need not be conducted. 8.1.1. Skin corrosion, in vitro 8.1.2. Skin irritation, in vitro 8.2. Serious eye damage/eye irritation 8.2. The study/ies do(es) not need to be conducted if: — the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1), or — the substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2), or — the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as serious eye damage (Category 1), or — the substance is spontaneously flammable in air or in contact with water or moisture at room temperature. 8.2.1. Serious eye damage/eye irritation, in vitro 8.2.1. If results from a first in vitro study do not allow a conclusive decision on the classification of a substance or on the absence of eye irritation potential, (an)other in vitro study/ies) for this endpoint shall be considered.’ (2) points 8.1 and 8.2 of Annex VIII shall be replaced by the following: ‘8.1. Skin corrosion/irritation 8.1. An in vivo study for skin corrosion/irritation shall be considered only if the in vitro studies under points 8.1.1 and 8.1.2 in Annex VII are not applicable, or the results of these studies are not adequate for classification and risk assessment. The study does not need to be conducted if: — the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or — the substance is spontaneously flammable in air or in contact with water or moisture at room temperature, or — the substance is classified as acute toxicity by the dermal route (Category 1), or — an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2 000 mg/kg body weight). 8.2. Serious eye damage/eye irritation 8.2. An in vivo study for eye corrosion/irritation shall be considered only if the in vitro study(ies) under point 8.2.1 in Annex VII are not applicable, or the results obtained from these study(ies) are not adequate for classification and risk assessment. The study does not need to be conducted if: — the substance is classified as skin corrosion, or — the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or — the substance is spontaneously flammable in air or in contact with water or moisture at room temperature.’ (3) point 8.5 of Annex VIII shall be replaced by the following: ‘8.5. Acute toxicity 8.5. The study/ies do(es) not generally need to be conducted if: — the substance is classified as skin corrosion. In addition to the oral route (Annex VII, 8.5.1.), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided. 8.5.2. By inhalation 8.5.2. Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. 8.5.3. By dermal route 8.5.3. Testing by the dermal route is appropriate if: (1) inhalation of the substance is unlikely; and (2) skin contact in production and/or use is likely; and (3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin. Testing by the dermal route does not need to be conducted if: — the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and — no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies).’

Other acts of the same type

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next

Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislation EU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and year European Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview