+CHAPTER 1 Authorisation requirement
---+Article 55 Aim of authorisation and considerations for substitution
---+Article 56 General provisions
------+Article 56 1.
------+Article 56 2.
------+Article 56 3.
------+Article 56 4.
------+Article 56 5.
------+Article 56 6.
---+Article 57 Substances to be included in Annex XIV
---+Article 58 Inclusion of substances in Annex XIV
------+Article 58 1.
------+Article 58 2.
------+Article 58 3.
------+Article 58 4.
------+Article 58 5.
------+Article 58 6.
------+Article 58 7.
------+Article 58 8.
---+Article 59 Identification of substances referred to in Article 57
------+Article 59 1.
------+Article 59 2.
------+Article 59 3.
------+Article 59 4.
------+Article 59 5.
------+Article 59 6.
------+Article 59 7.
------+Article 59 8.
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------+Article 59 10.

CHAPTER 1 Authorisation requirement

CHAPTER 1 Authorisation requirement

1. Panoramica

,
Article 55 Aim of authorisation and considerations for substitution

Article 55

Aim of authorisation and considerations for substitution

The aim of this Title is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.
Article 56 General provisions
Article 57 Substances to be included in Annex XIV

Article 57

Substances to be included in Annex XIV

The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:

▼M3

(a) 

substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008;

(b) 

substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/2008;

(c) 

substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to Regulation(EC) No 1272/2008;

▼C1

(d) 

substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation;

(e) 

substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;

(f) 

substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.
Article 58 Inclusion of substances in Annex XIV
Article 59 Identification of substances referred to in Article 57

1.1 Riferimenti

1.2 Requisiti identificati

1.3 Standard correlati

2. Requisiti identificati

Requisiti

3. Standard correlati

Standard