REACH24H Consulting Group

REACH Regulation (EC) No 1907/2006 contains 15 Titles, 17 Annexes and 10 Appendices. The Titles contain the main information requirements on the aim, scope, application of the Regulation, as well as information on fees and charges, supply chain information and enforcement. There is a specific title for data sharing - Title III Data Sharing and Avoidance of Unnecessary Testing, which highlights the aim to minimise animal testing.

The Annexes contain information requirements for Safety Data Sheet (SDS) and Chemical Safety Report (CSR) compilation, physicochemical, toxicological and eco-toxicological requirements and adaptations for registration all tonnage bands, list of exempted substances, criteria to identify persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances, and a list of substances subject to Authorisation and Restrictions on dangerous substances, preparations or mixtures in articles. The Appendices contain lists of substances that are Carcinogenic, Mutagenic or Toxic to Reproduction (CMR) Category 1 or 2 and other specific guidance on two substances that may have adverse effects on human health – asbestos and azocolourants. There are also more than 20 technical guidance documents released by ECHA and available in 21 official EU languages, to assist stakeholders in understanding every aspect of the Regulation.

Note: Article 58 of CLP Regulation (EC) No 1272/2008 details the Amendments to Regulation (EC) No 1907/2006 (REACH) that will be applicable from 1 December 2010. These amendments affect Articles 14, 31, 40, 57, 65, 68, 119, 138 and Annexes III, V, VI, VIII, IX, X, XIII and XVII.

REACH Regulation Titles

Title II - Registration
Substances that are manufactured in the EU or imported into the EU at quantities > 1 tonne per annum are subject to registration. For more information on Registration, please click here.

Title VI - Evaluation
The evaluation process is carried out by ECHA and consists of dossier evaluation (Articles 40-43) and substance evaluation (Articles 44-48).  The Agency have in place a compliance check process to review submissions (Article 41), where 5% of dossiers are evaluated at each tonnage level for adequate and accurate information. ECHA will also check testing proposals for substances above 100 tonnes per annum (Article 40) to ascertain whether the animal testing proposed is required. ECHA makes regular calls to request information from third parties to ensure that vertebrate animal testing is kept to the absolute minimum. A list of current consultations is available here.

Substance evaluation is co-ordinated with the Competent Authorities of EU Member States (Article 45). The criteria for substance evaluation prioritises substances using a risk-based approach according to hazard and exposure information and tonnage level (Article 44). The outcomes of substance evaluation range from action being taken under the Restriction or Authorisation procedures, or a proposal to change the Classification and Labelling.

Title VII - Authorisation

Authorisation is specific permission obtained from the EC to use a substance of very high concern (SVHC) for a specific purpose. Annex XIV of the REACh Regulation ‘List of Substances Subject to Authorisation’ will contain SVHC which cannot be placed on the market without authorisation. Article 57 details the criteria for substances that are to be included in Annex XIV - List of Substances Subject to Authorisation.

They include:

1. Substances classified as carcinogenic, mutagenic, or toxic (CMR) to reproduction category 1 or 2, in accordance with Directive 67/548/EEC (Dangerous Substances Directive);
2. Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB)
3. Substances that possess endocrine disrupting properties or those for which there is 'scientific evidence of probable serious effects to human health or the environment'.

Substances that meet this criteria are referred to as Substances of Very High Concern or SVHC. There is no tonnage threshold for a substance to be subject to authorisation. In practice, the authorisation process consists of four steps:

1. SVHC Identification

This is carried out by ECHA on behalf of the EC or Member State Competent Authorities. Annex XV outlines how to propose, justify and provide information on a SVHC. If ECHA decide that the substance is a SVHC, it will be added to a Candidate List.  An updated candidate list was released by ECHA in December 2010. Any substance on this list is eligible for inclusion in Annex XIV.

2. Prioritisation
This is carried out by ECHA on behalf of the EC or Member State Competent Authorities. ECHA will them prepare a list of priority substances from the Candidate List that it recommends to the EC for inclusion in Annex XIV. In accordance with Article 58 (3): 'Priority shall normally be given to substances with:

(a) PBT or vPvB Properties; or
(b) Wide Dispersive Use; or
(c) High Volumes.'

A series of public consultations are ongoing before ECHA makes a recommendation to the EC.  The second Annex XIV recommendation list was released in December 2010.

The prioritisation process will result in the following outcomes:

1. a decision on whether or not the substance will be subject to authorisation;
2. a list of uses that will not need authorisation
3. the 'sunset date'  - after this date the substance can only be used if authorised.

3. Application for Authorisation
The application by industry for authorisation must include:

1. A Chemical Safety Report that describes the risks associated with the substance that warrants its inclusion on the authorisation list
2. A comprehensive analysis of alternatives to the authorised substance, including alternative substances and technologies.
3. A socio-economic analysis if necessary

The fee for applying for an authorisation under Article 62 of Regulation (EC) No 1907/2006 is €50,000 (base charge).

4. Granting of Authorisation

Authorisation is granted by the European Commission. According to Recital 22 of EC 1907/2006, market authorisation should occur 'only if the risks arising from their use are adequately controlled, where this is possible, or the use can be justified for socio-economic reasons and no suitable alternatives are available, which are economically and technically viable'.  Ultimately, the aim is to replace substances of high concern with less dangerous alternatives.


Title VIII - Restriction
Restrictions will be imposed on substances that cause unacceptable risks to human or environmental health. The main aim of Restriction is to encourage manufacturers to produce and use safer alternatives to SVHC. Annex XVII of the REACh regulation - ‘Restrictions on the Manufacture, placing on the market and use of certain dangerous substances, preparations and articles' which contains the list of restricted substances and uses. There are 59 groups of substances or preparations on this list and they include:

• Polychlorinated terphenyls (PCT),
• Polycyclic-aromatic hydrocarbons (PAH),
• Benzene,
• Nickel,
• Arsenic and Mercury compounds,
• Polycyclic-aromatic hydrocarbons (PAH),
• Azocolourants (that release aromatic amines; see Appendix 8).

Title XI - Classification & Labelling Inventory
The Classification and Labelling (C&L) inventory is a database established and maintained by ECHA and comprises of the classification and labelling information of hazardous substances.  Title V of the CLP Regulation EC No 1272/2008 also sets out the provisions for the establishment and notification to the inventory.

Title IV - Supply Chain Communication
The REACh regulation makes clear that all actors in the chemical supply chain have a duty to communicate information about the hazard, use and risk information of their substances.

REACH Regulation Annexes

The REACH Annexes contain in-depth specific requirements for:

• Preparation of Chemical Safety Reports (CSR; Annex I)
• Guidance for compiling Safety Data Sheets (SDS; Annex II)
• Exemptions from registration obligations (Annex IV & V)
• Standard information requirements for registration of all tonnage bands (Annex VII, VIII, IX, X)
• General Rules for Adaptation of standard requirements provided on Annex VII – Annex X)
• Criteria to identify PBT and vPvB substances (Annex XIII)
• List of substances subject to Authorisation (Annex XIV)
• Restrictions on dangerous substances, preparations and articles being placed on the market (Annex XVII).

REACH Regulation Appendices

The 10 REACH Appendices contain lists of substances that fall into the following categories:

• Appendix 1 & 2:  Carcinogens - Category 1 or 2
• Appendix 3 & 4:  Mutagens - Category 1 or 2
• Appendix 5 & 6:  Toxic to Reproduction - Category 1 or 2
• Appendix 7: Provisions on labelling of articles containing asbestos
• Appendix 8 - 10: List of Azocolourants and testing methods