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Royal Decree 99/2003 Of 24 January, Amending The Regulation On The Notification Of New Substances And The Classification, Packaging And Labelling Of Dangerous Substances, Approved By Royal Decree 363/1995, Of 10 March.

Original Language Title: Real Decreto 99/2003, de 24 de enero, por el que se modifica el Reglamento sobre notificación de sustancias nuevas y clasificación, envasado y etiquetado de sustancias peligrosas, aprobado por el Real Decreto 363/1995, de 10 de marzo.

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TEXT

Royal Decree 363/1995 of 10 March, approving the Regulation on the notification of new substances and the classification, packaging and labelling of dangerous substances, incorporated into our legal system the Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67 /548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and packaging labelling of dangerous substances, as well as Commission Directive 91 /155/EEC, as amended by the first time by Directive 93 /112/EEC laying down and laying down detailed rules for the system of specific information for dangerous substances and preparations (safety data sheets).

Commission Directive 2001 /58/EC of 27 July 2001 amending for the second time Directive 91 /155/EEC laying down and laying down detailed rules for the system of specific information has recently been published. for dangerous preparations, pursuant to Article 10 of the Regulation on the classification, packaging and labelling of dangerous preparations, approved by Royal Decree 1078/1993 of 2 July 1993 and dangerous substances in application of the Article 23 of the Regulation on the notification of new substances and classification, packaging and labelling of dangerous substances, approved by Royal Decree 363/1995 of 10 March (safety data sheets). Its implementation will improve the technical criteria to be used by those responsible for placing a chemical substance on the market in order to produce the said chips.

By this Royal Decree, the provisions of Directive 2001 /58/EC, as regards dangerous substances, are partially incorporated into our legal system.

This Royal Decree is dictated by the provisions of Article 149.1.16.a and 23.a of the Constitution and in accordance with the provisions of Article 40 (5) and (6) of Law 14/1986 of 25 April, General of Health.

In its virtue, on the proposal of the Ministers of Health and Consumer Affairs, Environment and Science and Technology, the sectors affected, in agreement with the Council of State and after deliberation of the Council of Ministers, in its Meeting of the day 24 January 2003,

D I S P O N G O:

Single item. Amendment of the Regulation on the notification of new substances and the classification, packaging and labelling of dangerous substances, approved by Royal Decree 363/1995 of 10 March.

1. Article 23 (1) of the Regulation on the notification of new substances, classification, packaging and labelling of dangerous substances is replaced by

following:

" In order to adopt a system of information aimed primarily at professional users that allows them to take the necessary measures for the protection of health and safety at the workplace, the responsible the placing on the market of a dangerous substance, whether the manufacturer, the importer or the distributor, must have a safety data sheet at the time of marketing. A copy of the same will be submitted to the Ministry of Health and Consumer Affairs, which will keep it at the disposal of the Ministry of the Environment and the Autonomous Communities that request it.

Such a token may be provided by paper, or preferably in electronic form, provided that the recipient has the necessary equipment.

The person responsible for the placing on the market of a chemical, whether the manufacturer, the importer or the distributor, shall provide the consignee of the substance which is a professional user with the said data sheet security containing the information specified in paragraph 3 of this Article and in Annex XI, in case the substance is classified as dangerous in accordance with this Regulation.

The information will be provided free of charge and never later than the first delivery of the substance, and, subsequently, provided that there are revisions originating from the emergence of new significant knowledge. on safety and the protection of health and the environment. "

2. The text of Annex XI is replaced by the text in the Annex to this Royal Decree.

Final disposition first. Faculty of development.

Without prejudice to the powers of the Ministry of Labour and Social Affairs and the competent bodies in the field of safety and hygiene at work referred to in Article 24 (3) of the notification Regulation of new substances and classification, packaging and labelling of dangerous substances, approved by Royal Decree 363/1995 of 10 March, the Ministers for Health and Consumer Affairs are empowered,

of the Environment and Science and Technology so that, in the field of their respective competences, they proceed to the development of the provisions in this Royal Decree, as well as to dictate the norms necessary for the updating of the technical annexes contained therein.

Final disposition second. Competence title.

This provision is made in accordance with the provisions of Article 149.1.16.a and 23.a of the Constitution and in accordance with the provisions of Article 40 (5) and (6) of Law 14/1986 of 25 April, General of Health.

Final disposition third. Entry into force.

This Royal Decree will enter into force on the day following its publication in the "Official State Gazette".

Dado en Madrid, a 24 de enero de 2003.

JOHN CARLOS R.

First Deputy Prime Minister and Minister of the Presidency, MARIANO RAJOY BREY

ANNEX

" ANNEX XI Guide for the elaboration of safety data sheets This Annex aims to ensure the consistency and accuracy of the content of each of the mandatory headings listed in Article 23.3 of the this Regulation, so that the safety data sheets so developed allow professional users to take the necessary measures with regard to the protection of health and safety in the workplace and to the protection of the environment environment.

The information provided in the safety data sheets must meet the conditions set out in Royal Decree 374/2001 of 6 April 2001 on the protection of the health and safety of workers against the risks related to chemical agents during work. In particular, the safety data sheet should enable the employer to determine whether any hazardous chemical agent is present at the workplace and to assess any risks posed by the use of such agents for health and safety. of the workers.

The information must be written in a clear and concise manner. The safety data sheets should be prepared by competent persons taking into account the specific needs of the users to which they are intended, in so far as they are known. Those responsible for the placing on the market of substances should ensure that these competent persons receive the relevant training, including continuing training activities.

In some cases, due to the wide range of substance properties, additional information may be required. If, in other cases, information on some properties is not relevant and it is technically impossible to provide it, the reasons must be clearly specified under each heading. Information on each hazardous property should be provided. If it is indicated that a particular hazard is not applicable, it should be clearly distinguished between the cases where the classifier does not have information and the cases in which evidence has been tested with negative results.

On the first page of the security data sheet you must enter your date of issue.

In case a safety data sheet is reviewed, the changes must be communicated to the recipient.

Certain substances and preparations (for example, solid metals, alloys, compressed gases, etc.) listed in Chapters 8 and 9 of Annex VI to this Regulation and to which derogations are applied in respect of the Labelling requirements should also be available for safety data sheets.

I. Identification of the substance and of the company or company

1. Identification of the substance.

The term used for identification shall be identical to the term on the label as defined in Annex VI to this Regulation.

Other available means of identification may also be indicated.

2. Use of the substance.

Identify the intended or recommended uses of the substance to the extent that they are known.

When there are many possible uses, it will only be necessary to indicate the most important or common. A brief description of the actual effect should be included, such as flame retardant, antioxidant, etc.

3. Identification of the company or company.

Identify the person responsible for placing the substance on the market, be it the manufacturer, the importer or the distributor, giving its full address and telephone number.

In addition, if that person is not established in the Member State in which the substance is placed on the market, give the full address and telephone number of the person in charge in that Member State, where possible.

4. Emergency telephone.

In addition to the above information, facilitate the emergency telephone number of the company or the competent official advisory body.

II. Composition/information about the components

The information provided should allow the recipient to know without difficulty the hazards that the components of the preparation may present. The dangers themselves are the subject of paragraph III.

1. It is not necessary to indicate the complete composition (nature of the ingredients and their concentration), although a general description of the components and their concentrations may be useful.

2. In the case of preparations classified as hazardous in accordance with the Regulation of preparations, the following substances shall be indicated together with their concentration or concentration range:

(a) Substances which are dangerous to health or the environment in accordance with this Regulation, if they are present in concentrations equal to or greater than those laid down in the table set out in Article 3 (3) of the Regulation of dangerous preparations (except for lower limits in Annex I to this Regulation or in Annexes II, III or V to the Prepared Regulation); and (b) Substances for which Community exposure limits exist at the site which are not already included in the subparagraph (a).

3. In the case of preparations which are not classified as dangerous according to the Regulation of preparations, the following substances shall be indicated, together with their concentration or concentration range, if they are present in an individual concentration ' 1 by weight 100, for preparations other than gaseous, and ' 0,2 per 100 by volume for gaseous preparations:

(a) Substances which are dangerous to health or to the environment in accordance with this Regulation.

Where the person responsible for placing the preparation on the market can demonstrate that the disclosure, on the label or on the safety data sheet, of the chemical identity of a substance that is exclusively classified as:

1.o Irritant, other than those assigned to R41, or irritant and which present one or more of the other properties referred to in Article 9 (4) (c) (4) of the Dangerous Preparations Regulation, or 2.o Harmful, or harmful and which present one or more of the properties referred to in Article 9 (4) (c) (4) of the Regulation on dangerous preparations and shall in itself present a lethal acute effect, shall entail a risk to the confidential nature of the its intellectual property, shall be permitted, in accordance with the provisions of Annex VI, to refer to that substance either by a name identifying the most important functional chemical groups, or by an alternative designation

(b) Substances for which there are Community exposure limits in the workplace.

4 For the substances referred to above, the classification, derived from Article 5 or Annex I to this Regulation, must be indicated, including the R symbols and phrases assigned to them according to the hazards which, from the physico-chemical point of view, represent health or the environment. It is not necessary to write the complete R phrases here, but reference should be made to paragraph XVI, where the full text of each relevant R-sentence should be included.

5. The name and number EINECS or Elincs of the substances mentioned above should be indicated in accordance with this Regulation.

It may be useful to also quote the CAS number and the IUPAC name (if any). In the case of substances which appear under a generic name, in accordance with Article 14 of the Dangerous Preparations Regulation, it is not necessary to indicate precisely the chemical identity.

6. If, in accordance with Article 14 of the Dangerous Preparations Regulation, confidentiality on the identity of certain substances should be maintained, their chemical nature must be described in order to ensure safety in the handling. The name used must be the same as the name derived from the application of the procedures referred to above.

III. Hazard identification

Provide here the classification of the substance derived from the application of the classification rules of this Regulation. Please indicate clearly and briefly the dangers posed by the substance to man and the environment.

Describe the main adverse effects both physico-chemical and human health and the environment, as well as the symptoms related to the correct and incorrect uses of the substance that can be foreseen.

It may be necessary to mention other hazards, such as exposure to dust, choking, freezing, or environmental effects, such as hazards to soil organisms, etc., which do not lead to classification but which can contribute to the general hazards of the material.

The information on the label must be indicated under paragraph XV.

IV. First aid

Describe first aid.

Specify first if immediate medical assistance is required.

First aid information must be brief and easy to understand by the accident, the present and the emergency services. Symptoms and effects should be briefly described.

It will be indicated in the instructions what is to be done on the ground in the event of an accident and whether delayed effects are foreseeable after an exposure.

Foresee different sub-headings according to the different routes of exposure, i.e. inhalation, contact with the skin or with eyes and ingestion.

Indicate whether to consult a doctor if it is advisable or advisable.

It may be important, in the case of some substances, to stress the need for special means to be available in the workplace for immediate specific treatment.

V. Fire fighting measures

Indicate the rules for the control of a fire caused by the substance, or originating in its vicinity, by reference to the appropriate means of extinction, the means of extinction which must not be used for reasons of safety, the special hazards resulting from exposure to the substance itself, to the combustion products or to the gases produced, and the special protective equipment for fire-fighting personnel.

VI. Measures in case of accidental dumping

According to the substance concerned, information may be needed on:

(a) Personal precautions: suppression of ignition bulbs, sufficient ventilation/respiratory protection, dust control, prevention of contact with skin and eyes, etc.

(b) Precautions for the protection of the environment: removal of drains, surface water and groundwater, as well as soil; possible alert to the neighbourhood, etc.

c) Cleaning methods: use of absorbent materials (e.g., sand, diatom soil, acid binder, universal binder, sawdust, etc.), reduction of gases/fumes with water projection, dilution, etc.

Consider also the need to give indications of the type: ` ` never use, neutralize with ... ''.

If deemed appropriate, refer to paragraphs VIII and XIII.

VII. Handling and storage

The information collected in this section should be related to the protection of health, safety and the environment, as well as to help the entrepreneur develop working methods and organizational measures that are appropriate to Royal Decree 374/2001 of 6 April 2001.

1. Handling.

Specify the necessary precautions to ensure safe handling, including recommendations on technical measures such as containment, local and general ventilation, those intended to prevent the formation of aerosols and dust, or to prevent fires, as well as measures to protect the environment (e.g. use of filters or gas washers in the aeration exits, use in an area provided with barriers, measures of collection and disposal of spilled fractions, etc.) and any other requirements or standards specific to the substance (e.g. recommended or prohibited equipment and procedures), providing a brief description of the substance.

2. Storage.

Specify the conditions required for safe storage such as: special design of premises or storage tanks (including ventilation and protective walls), incompatible materials, conditions storage (limited/range of temperature and humidity, light, inert gases, etc.), special electrical equipment and prevention of static electricity accumulation.

Where appropriate, please indicate the limit quantities that may be stored. Indicate in particular any specific requirements such as the type of material used in the container or container of the substance.

Mention any storage-related community disposition. In the absence of Community provisions, it would be appropriate to remind the user that there may be existing national, regional or local provisions.

3. Specific uses.

In the case of finished products intended for specific uses, the recommendations should relate to the intended uses, in addition to being detailed and applicable to the actual conditions.

Where possible, reference shall be made to the approved guidelines specific to the industry or sector concerned.

VIII. Controls on personal exposure/protection

1. Limit values for the exposure.

Specify specific control parameters that are applicable at the time, including professional exposure limit values and/or biological limit values. Values should be given for the Member State in which the substance is marketed. Give information about currently recommended tracking methods.

2. Controls of the exhibition.

For the purpose of drawing up the safety data sheets, the notion of exposure control covers all the specific protection and prevention measures to be taken during the use to minimise the exposure. (i) the exposure of workers and the environment.

a) Controls of professional exposure.

The employer must take this information into account when carrying out an assessment of the risk to the health and safety of workers of the substance under Royal Decree 374/2001 of 6 April 2001. (i) the concept of appropriate working procedures and technical controls, the use of appropriate equipment and materials, the application of collective protection measures at the origin of the risk and, finally, the use of individual protection, such as personal protective equipment. It is therefore necessary to provide relevant information on these measures so that an appropriate risk assessment can be carried out in accordance with Royal Decree 374/2001 of 6 April 2001.

This information will be complementary to that provided in section VII.1.

In cases where personal protection is necessary, please specify in detail the type of equipment that provides adequate protection. To that end, the provisions of Royal Decree 1407/1992 of 20 November 1992 governing the conditions for the marketing and free movement within the Community of individual protective equipment and their subsequent amendments and refer to the relevant CEN standards.

1.o Respiratory protection.

If these are hazardous gases, vapours or powders, specify the appropriate type of protective equipment, such as self-contained breathing apparatus, masks, and suitable filters.

2.o Skin Protection. Hands.

Specify the type of gloves to be used for handling the substance, indicating:

the type of material, and the time of penetration of the material of the gloves, in relation to the quantity and duration of the skin exposure.

When necessary, indicate any additional measures of hand protection.

3.o Eye protection.

Specify the type of eye protection you need: safety glasses, goggles, face screens, etc.

4.o Skin Protection. Rest of the body.

When it is necessary to protect a different body part from the hands, specify the type and quality of the protective equipment required: mono, apron, boots, etc. Where necessary, indicate any additional measures for skin protection and for particular hygiene.

b) Controls of environmental exposure.

Specify the information needed by the employer to fulfil its obligations under Community environmental protection legislation.

IX. Physical and chemical properties

To allow for the adoption of appropriate control measures, provide all relevant information on the substance, particularly the information collected under section IX.2.

1. General information.

Appearance.

Indicate the physical state (solid, liquid, gas) and the color of the substance as supplied.

Smell.

If the smell is noticeable, describe it briefly.

2. Important information regarding health, safety and the environment.

pH.

Indicate the pH of the substance as supplied or an aqueous solution; in the latter case, indicate the concentration.

Boiling point/range.

Inflammation point.

Flammability (solid, gas).

Explosive properties.

Oxidant Properties.

Steam pressure.

Relative density.

Solubility: water solubility, liposolubility (specify the solvent oil).

Distribution coefficient: n-octanol/water.

Viscosity.

Vapor Density.

Evaporation rate.

3. Other data.

Indicate other important safety parameters such as miscibility, conductivity, melting point/range, gas group, spontaneous ignition temperature, etc.

These properties shall be determined in accordance with the provisions of Part A of Annex V to this Regulation or any other equivalent method.

However, if it is indicated that a particular hazard is not applicable, it should be clearly differentiated between the cases where the classifier does not have information and the cases in which evidence has been tested with negative results. Where it is considered necessary to provide information on the properties of different components, it should be clearly stated to which the data relate.

X. Stability and reactivity

Indicate the stability of the substance and the possibility of dangerous reactions occurring under certain conditions of use and also in case of release to the environment.

1. Conditions to be avoided.

List these conditions, such as temperature, pressure, light, shocks, etc., that can cause a dangerous reaction and, if possible, describe them briefly.

2. Subjects to be avoided.

Enumerate the materials, such as water, air, acids, bases, oxidants or other specific substances, that can cause a dangerous reaction and, if possible, describe them briefly.

3. Hazardous decomposition products.

List dangerous substances produced in disturbing quantities as a result of decomposition.

Expressly: the need and presence of stabilizers, the possibility of a dangerous exothermic reaction, any repercussions that a change in the physical appearance of the substance may have on safety, hazardous decomposition products which may eventually be formed as a result of contact with water and the possibility of degradation to unstable products.

XI. Toxicological information

This section responds to the need to give a concise, yet complete and understandable description of the different toxic effects (on health) that can be given when the user comes into contact with the substance.

The hazardous health effects due to exposure to the substance will be included, whether these effects are based on actual cases or whether they relate to conclusions of scientific experiments. Information on the different routes of exposure (inhalation, ingestion, skin and eye contact) will be included and symptoms related to physical, chemical and toxicological properties will be described.

Indicate known immediate delayed effects, as well as the chronic effects produced by short and long-term exposure: for example, sensitization, narco-sis, carcinogenic, mutagenic and toxic effects for the reproduction (developmental toxicity and fertility).

XII. Ecological information

Describe the possible effects, behavior, and environmental fate of the substance in the air, water, or soil. The relevant evidence data should be collected (e.g. CL50 fish "). 1 mg/l).

Describe the most important characteristics that may affect the environment due to the nature of the substance and its foreseeable forms of use. To provide information of the same type on hazardous products resulting from the degradation of substances. The following aspects can be included:

1. Ecotoxicity.

Relevant data on aquatic toxicity, both acute and chronic, should be collected for fish, dafnias, algae and other aquatic plants. In addition, the available toxicity data on micro and macro-organisms of the soil and other relevant organisms from the point of view of the environment, such as birds, bees and plants, should be included. Where the substance has inhibitory effects on the activity of micro-organisms, the possible impact on sewage treatment plants should be mentioned.

2. Mobility.

Capacity of the substance, in case of discharge to the environment, to go to the groundwater or away from the landfill site.

The relevant data may include the following: known or predicted distribution in the different environmental compartments, surface tension and absorption/desorption.

In relation to other physicochemical properties, see paragraph IX.

3. Persistence and degradability.

Capacity of the substance or relevant components of a preparation for degradation in appropriate environmental media, either by biodegradation or by other processes, such as oxidation or hydrolysis. The half-lives of degradation that are available should be reported. The capacity of the substance or the relevant components of a preparation to be degraded in sewage treatment plants should also be mentioned.

4. Bioaccumulation potential.

Capacity of the substance to accumulate in living beings and pass along the food chain, relative to its Kow and FBC, if this data is available.

The information referred to in paragraphs XII.2, XII.3 and XII.4 cannot be given for the preparation because it depends on the substances. It should therefore be provided, where appropriate, for each substance in the preparation to be included in the safety data sheet, in accordance with the rules set out in paragraph II of this Annex.

5. Other harmful effects.

Include available data on other harmful effects in the environment, such as ozone depletion capacity, ozone photochemical formation, or Earth heating.

Information relating to the environment must be provided in other headings of the safety data sheet and in particular advice on controlled dumping, measures in case of accidental dumping, transport and considerations on disposal, in paragraphs VI, VII, XIII, XIV and XV.

XIII. Removal considerations

If the disposal of the substance (surplus or waste resulting from its foreseeable use) represents a hazard, a description of these residues should be provided, as well as information on how to manipulate them without danger.

Indicate the appropriate methods of disposal of the substance, as well as any contaminated packaging (incineration, recycling, controlled discharge, etc.).

Mention any community provisions related to the disposal of waste. In the absence of Community provisions, it would be appropriate to remind the user that there may be existing national, regional or local provisions.

XIV. Transport information

Indicate any special precautions that the user should be aware of or take, in relation to the transport in and out of their facilities. Where appropriate, information on the classification of transport in relation to the rules on the different modes of transport should be provided: IMDG (International Maritime Code for Dangerous Goods), ADR (European Agreement on the International Transport of Dangerous Goods by Road), RID (International Regulations on the Transport of Dangerous Goods by Rail), ICAO/IATA (Technical Instructions for Transport without Hazards of Dangerous Goods by Air) and DNA (European Regulations Relating to Transport International of Dangerous Goods by Inland Waterways). This information could include aspects such as the following: UN number, class, transport name, classification group, marine pollutant and other relevant information.

The mandatory documentation for the carriage of goods subject to the rules referred to in the preceding paragraph is described in paragraph 5.4.1 of these rules (Dangerous Goods Transport Document).

XV. Regulatory information

Information on the health, safety and environment on the label should be given in accordance with this Regulation.

If the substance referred to in the safety data sheet is the subject of special provisions concerning the protection of man or the environment, required by Royal Decree 1406/1989 of 10 November 1989, by the that restrictions are imposed on the marketing and use of certain dangerous substances and preparations, such provisions should be cited as far as possible.

And whenever possible, any other rule that applies the particular provisions mentioned in the previous paragraph must be mentioned.

XVI. Other information

Indicate any other information that the supplier considers important for the health and safety of the user, as well as for the protection of the environment; for example: list of relevant R phrases, with the full text of all R phrases referred to in paragraphs II and III of the safety data sheet, training advice, recommended use restrictions (e.g. supplier recommendations not imposed by law), other information (written references or technical contact point), sources of the main data used to draw up the information sheet, if the safety data sheet is reviewed, clearly indicate the information which has been added, deleted or revised (unless otherwise indicated). '