Order JUS/836/2013 of 7 May, which regulates the procedure for the notification of the high, low and modifications of toxicological data sheets to the chemical register of the Information Service of the National Institute of Toxicology and Forensic Sciences and the rate of the rate provided for in Law 10/2012 of 20 November, regulating certain fees in the field of the Administration of Justice and the National Institute of Toxicology and Forensic Sciences, established the regulatory channel for importers and users Intermediate, placing on the market mixtures and substances classified as dangerous, communicate the composition and the chemical identity to this Institute.

In this way they are allowed to comply with the provisions of Article 45 (1) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures, and amending and repealing Directives 67 /548/EEC and 1999 /45/EC and amending Regulation (EC) No 1907/2006.

The forecasts of the increase of companies and products to be notified to the aforementioned Institute, as well as the difficulties encountered in the implementation of the necessary IT procedure for the management of the elevated the number of toxicological data sheets to be submitted by the companies before 1 June 2015-the date on which the obligation to communicate is required-justify this transitional procedure.

The information referred to in the safety data sheet and the label drawn up in accordance with the provisions of Commission Regulation 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council The European Parliament and the Council on the registration, assessment, authorisation and restriction of chemicals (REACH) and Title III of Regulation (EC) No 1272/2008 respectively constitute the common minimum framework for information necessary to give toxicological response. This is without prejudice to the fact that, in order to provide additional information which is technically possible to provide a more comprehensive formulation of preventive and curative measures, the additional information is required. required on the toxicological tab.

Hence, the associations of companies that are most representative of the sector are heard, and a transitional period of communication is articulated to that of the toxicological data sheets, which in no case will lead to the high of the products in the base of the data from the Toxicological Information Service, although it will allow companies to comply with the communication rules to the anti-toxic centre, without prejudice to subsequent communication, within the time limits laid down, through the procedure ordinary.

In its virtue, on a proposal from the Ministry of Justice, with the prior approval of the Minister of Finance and Public Administrations, according to the State Council,

DISPONGO:

Single item. Amendment of Order JUS/836/2013 of 7 May, which regulates the procedure for the notification of the high, low and modifications of toxicological data sheets to the register of chemicals in the Information Service of the National Institute of Toxicology and Forensic Sciences and the rate of the rate provided for in Law 10/2012 of 20 November, regulating certain fees in the field of the Administration of Justice and the National Institute of Toxicology and Forensic Sciences.

A third transitional provision is added to Order JUS/836/2013 of 7 May, which regulates the procedure for the notification of high, low and modifications of toxicological data to the registration of chemical products. of the Toxicological Information Service of the National Institute of Toxicology and Forensic Sciences and the rate of liquidation provided for in Law 10/2012, with the following wording:

" Transitional provision third. Transitional system of communication to the National Institute of Toxicology and Forensic Sciences.

1. A transitional period of communication is established, up to the dates indicated in paragraph 3 of this provision, which will only affect the communication of the discharge in the register of chemicals in the Information Service. Toxicology of the toxicological data sheets referred to in Article 8.1.a) of this Order, communication to be carried out during that period following the communication model approved by the INTCF published on the website of the Management Portal https://www.administraciondejusticia.gob.es/

2. This transitional period shall apply to importers and downstream users who market mixtures which, in compliance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and amending and repealing Directives 67 /548/EEC and 1999 /45/EC and amending Regulation (EC) No 1907/2006 (hereinafter the CLP Regulation), should notify the INTCF of their chemical composition by first time before June 1, 2015.

3. The companies concerned are obliged to carry out, after all, the discharge of the toxicological information in the register of chemical products of the INTCF Toxicological Information Service within the following time limits:

a) Before 1 January 2016:

1. Mixtures placed on the market for the consumer which are classified as dangerous due to their effects on human health or their physical effects in accordance with the classification criteria of the CLP Regulation.

2. Mixtures placed on the market for professional uses classified as dangerous, according to the CLP Regulation due to their effects on human health, in the following hazard classes:

• Acute (oral, dermal and inhalational) toxicity categories 1, 2 and 3 (H300/H30 1/H310/H311/H330 /H331)

• Systemic toxicity: STOT single and repeated exposure, categories 1 and 2 (H370/H371/H372/H373)

• Skin or eye corrosion, category 1 (H314/H318)

• CMR category 1A, 1B and 2 (H340/H341/H350/H351/H360/H361). Skin sensitisers and respiratory category 1 (H317/H334).

(b) Before 1 June 2017, the remaining mixtures affected by Article 45 of the CLP Regulation.

4. However, any company may voluntarily notify the INTCF of the mixtures it markets through the ordinary procedure laid down in this Ministerial Order for the notification of high, low and modifications of toxicological data sheets. the chemical product registration of the INTCF Toxicological Information Service regardless of its hazard classification.

5. The communication shall contain the documents referred to in Article 8.1 (b) and (c)-the label and the safety data sheet-and shall not be subject to the payment of the fees set out in Law 10/2012 of 20 November. which shall be made at the time when the toxicological information is to be discharged in accordance with the ordinary procedure laid down in this Ministerial Order.

6. This transitional period shall not apply to undertakings which use the telephone of the Toxicological Information Service as an emergency telephone in point 1.4 of the safety data sheets, or to record it on the labels of the mixture. "

Single end disposition. Entry into force.

This order shall enter into force on the day following that of its publication in the "Official State Gazette".

Madrid, May 29, 2015. -Minister of Justice Rafael Catala Polo.