
Article 1 
Annexes VII and VIII to Regulation (EC) No 1907/2006 are amended in accordance with the Annex to this Regulation.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 31 May 2016.
For the Commission
The President
Jean-Claude JUNCKER
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:
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8.1. Skin corrosion/irritation
 
8.1. 

— 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 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.
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((2)) points 8.1 and 8.2 of Annex VIII shall be replaced by the following:
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8.1. Skin corrosion/irritation
 
8.1. 
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. 
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.
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((3)) point 8.5 of Annex VIII shall be replaced by the following:
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8.5. Acute toxicity
 
8.5. 

— 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. 

((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).
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