The Regulation on the declaration of new substances and the classification, packaging and labelling of dangerous substances, approved by Royal Decree 2216/1985 of 23 October, as amended by Royal Decree 725/1988 of 3 June, and The Council Directive of 7 September 1988 on the approximation of the laws of the Member States relating to the approximation of the laws of the Member States relating to the approximation of the laws of the Member States relating to the approximation of the laws of the Member States relating to the approximation of the laws of the Member States the laws, regulations and administrative provisions relating to classification, packaging and labelling of dangerous substances, as well as subsequent modifications and adaptations to technical progress.

The experience gained in the application of the abovementioned provisions, as well as the new knowledge in the field, have led to the adoption of Council Directive 92/32/EEC of 30 April, which provides for the seventh amendment of Directive 67 /548/EEC, and it involves major changes to the current regulation, in order to achieve a higher level of protection of the health and safety of the population and the environment, as well as a greater transparency in market conditions for these substances and which is incorporated into our legal order by means of this Royal Decree. Directive 92/32/EEC has, in turn, been developed and supplemented by Directives 92 /37/EEC, 92 /69/EEC, 93 /21/EEC, 93 /67/EEC, 93 /72/EEC, 93 /90/EEC, 93 /105/EEC and 93 /112/EEC, all of which are necessary to be incorporated into the Directive. legal order, which is also carried out by this Royal Decree. In this way, this provision establishes a complete and up-to-date regulation of this matter. To this end, the aspects referred to in Directives 87 /302/EEC and 91 /410/EEC, which had already been partially transposed by the Ministerial Order of 13 November 1989 and the abovementioned Ministerial Order of 9 December 1989, have also been incorporated. December 1992, orders now being repealed.

With regard to the previous regulation, which is now repealed, this regulation provides for new definitions and changes of others, in particular those affecting the hazard categories of substances and preparations. dangerous; introduces a new symbol and indication of danger to the environment, and extends and updates the criteria for classification and labelling. It also extends the content of the label, incorporating the EEC number and the new phrase 'EEC label' for the substances listed in Annex I, and establishes an information system for the substances set up by the data sheet. (a) security, primarily intended for the professional user, which contributes to the promotion of environmental protection, health and safety at work.

Furthermore, the requirements for the notification procedure for new substances are incorporated, a procedure which is uniform and harmonised for all the countries of the European Union.

In this respect, a simplified notification system for substances which are placed on the market in quantities of less than one tonne per year and manufacturer is established and a common procedure for the exchange of information is established and the possibility of designating, in the case of substances manufactured outside the internal market, a single representative for the purposes of notification.

Measures are also established to prevent the repetition of animal testing; these tests should be governed by the principles of good laboratory practice and the existing rules on the protection of animals used for experimentation and other scientific purposes. Equally noteworthy is the existence of the European Inventory of Existing Commercial Substances "EINECS", the consultation of which is established as prior to the initiation of the notification procedure.

It should be noted, on the other hand, that in the face of the current regulation of substances, which only collects the identification of the intrinsic danger thereof, this Royal Decree provides for the risk assessment of the notified substances, the result of which will serve as a basis for the adoption of measures aimed at reducing the risks arising from their marketing and use, even allowing for the possibility to take restrictive measures prior to placing on the market of the substances, in order to achieve greater protection of public and environmental health environment.

It has also been considered appropriate to introduce, in the operative part, an amendment to the Regulation on the classification, packaging and labelling of dangerous preparations, approved by Royal Decree 1078/1993 of 2 July 1993, as a consequence of the need to replace the concept of 'teratogenic effects' with 'reproductive toxicity', as derived from Article 2 of Directive 92/32/EEC, which is amended by Directive 88 /379/EEC.

It should be considered, finally, that the regulation made by this Royal Decree strengthens the conception of the European Union, so that the expression "internal market" will be understood to imply a space without internal frontiers at Community level, in which the free movement of goods, persons, services and capital is ensured in accordance with the provisions of the Treaty establishing the European Community, in terms of its provided for in Article 14 of the Single European Act.

Therefore, under the obligations arising from the membership of the Spanish State to the European Communities, the provisions contained in the Council Directive must be incorporated into our legal order. 92 /32/EEC of 30 April 1992 amending for the seventh time Directive 67 /548/EEC and Directives 87 /302/EEC, 91 /410/EEC, 92 /37/EEC, 92 /69/EEC, 93 /21/EEC, 93 /67/EEC, 93 /72/EEC, 93 /90/EEC, 93 /105/EEC and 93 /112/EEC by means of this standard (a) the provisions of Article 149.1.16 of the Constitution and of the Constitution and of the Agreement with Article 40 (5) and (6) of Law 14/1986 of 25 April 1986, General Health.

In its virtue, on the proposal of the Minister of Health and Consumer and of the Minister of Industry and Energy, with favorable report of the Inter-Ministerial Commission of Coordination of the Transport of Dangerous Goods, ears the sectors The Council of Ministers agreed with the Council of State and the Council of Ministers at its meeting on 10 March 1995, in agreement with the Minister for Public Administrations.

D I S P O N G O:

Single item.

The Regulation on the notification of new substances and the classification, packaging and labelling of dangerous substances, which is inserted below, is adopted.

Additional disposition first.

The Regulation on the classification, packaging and labelling of dangerous preparations, approved by Royal Decree 1078/1993 of 2 July 1993, is amended as follows:

1. The words 'carcinogenic, mutagenic and teratogenic effects' shall be replaced by the following: 'carcinogenic, mutagenic and reproductive effects'.

2. The text of paragraphs 15, 16, 16 and 17. of Article 3.5 shall be worded as follows:

"3.5.15. °. They shall be considered to be toxic for reproduction and shall at least be characterised by the danger symbol and the indication of" toxic " danger, the preparations containing a substance producing these effects and to which it is apply at least one of the R-phrases defined in Annex VI to the Substance Regulation, which characterises 'toxic for reproduction' substances of category 1 with a concentration equal to or higher:

-Well as set out in Annex I to the Substance Regulation for the substance concerned.

-Well as set out in Annex I (Tables VI and VI-A) of this Regulation, where the substance is not listed in Annex I to the Regulation of substances or where the substance is not contained in concentration limits.

3.5.16. º. They shall be deemed to be equivalent to toxic for reproduction and shall at least be marked by danger symbol and the indication of "toxic" danger, preparations containing a substance producing these effects. and to which at least one of the R-phrases defined in Annex VI to the Substance Regulation is applied, which characterises toxic substances for category 2 reproduction in a concentration equal to or higher:

-Well as set out in Annex I to the Substance Regulation for the substance concerned.

-Well as set out in Annex I (Tables VI and VI-A) to this Regulation, where the substance or substances concerned are not listed in Annex I to the Regulation or when the substances or substances are not included in concentration limits.

3.5.17. ° The preparations containing a substance producing these effects and the indication of danger "harmful" shall be deemed to be equivalent to toxic for reproduction and at least marked by the danger symbol and the indication of "harmful" danger. For at least one of the R-phrases defined in Annex VI to the Substance Regulation, which characterises 'toxic for reproduction' substances of category 3 with a concentration equal to or greater than:

-Well as set out in Annex I to the Substance Regulation for the substance concerned.

-Well as set out in Annex I (Tables VI and VI-A) to this Regulation, where the substance or substances concerned are not listed in Annex I to the Regulation or when the substances or substances are not included in the concentration limits. '

3. Article 3.15 (17), in its current wording, becomes paragraph 18. of the same article.

4. In Article 8, a new paragraph 3a is inserted, with the following wording:

" 3 bis. The information to be included on the label in accordance with Article 7 shall be highlighted in the background, have sufficient dimensions and cover sufficient space to be easily legible.

Specific provisions concerning the presentation and format of such information shall be laid down in Annex VI to the Substances Regulation. "

5. In the title of Part 6 of Annex I, the expression 'teratogenic effects' is replaced by the expression 'effects on reproduction'.

6. In Tables VI and VI-A of Annex I, the expression 'teratogenic substances' is replaced by the expression 'toxic substances for reproduction'.

Additional provision second.

This Royal Decree is issued pursuant to Article 149.1.16. and 23. 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.

Additional provision third.

To the activities, services and studies related to the notification process, the rate established by article 26 of Law 42/1994, of December 30, of Fiscal, Administrative and Order Measures will apply to them. Social.

First transient disposition.

The requirements laid down in Articles 18, 19 and 20 of the Regulation, which are adopted, shall not be required when they apply to liquefied petroleum gases until 30 April 1997.

Second transient disposition.

The hazardous substances affected by the regulations which are established may continue to be placed on the market under the conditions of classification, packaging and labelling required prior to the entry into force of the Regulation. approved by this Royal Decree, for a period of 18 months from that entry into force, in order to enable the industries to take the necessary measures to comply with it. A maximum period of 18 months shall also be granted, starting from the entry into force of this Royal Decree, in order to draw up the safety data sheets referred to in Article 23 of the regulation to be adopted.

Single repeal provision.

The Royal Decree 2216/1985 of 23 October 1985 approving the Regulation on the declaration of new substances and the classification, packaging and labelling of dangerous substances; Royal Decree 725/1988 of 3 December 1988, June, amending the Regulation on the declaration of new substances and the classification, packaging and labelling of dangerous substances, approved by Royal Decree 2216/1985 of 23 October 1985; the Orders of 7 September 1988, 29 In November 1990 and 9 December 1992, the technical management of the Community was updated. Regulation on the declaration of new substances and the classification, packaging and labelling of dangerous substances, approved by Royal Decree 2216/1985 of 23 October 1985; the Order of 14 March 1988 for the development of test methods for the determination of the properties of dangerous substances; the Order of 13 November 1989 for the addition of new test methods for the determination of the properties of dangerous substances to those approved by order of 14 March 1989 of 1988, and any provisions of equal or lower rank shall be contrary to the provisions of this Royal Decree.

First disposition first.

The Ministers of Health and Consumer Affairs and Industry and Energy are empowered to proceed in the field of their respective competences to the development of the provisions of this Royal Decree, as well as to lay down the necessary rules. for the updating of the technical annexes contained therein.

Final disposition second.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State", without prejudice to the provisions of the transitional provisions.

Dado en Madrid a 10 de marzo de 1995.

JOHN CARLOS R.

The Minister of the Presidency,

ALFREDO PEREZ RUBALCABA

(In addition, the Regulation is published)

REGULATION ON NOTIFICATION OF NEW SUBSTANCES AND CLASSIFICATION, PACKAGING AND LABELLING OF DANGEROUS SUBSTANCES

CHAPTER I

Scope and definitions

Article 1. Scope of application.

1. This Regulation regulates:

a) The notification of the substances.

b) The exchange of information on notified substances.

c) The assessment of the possible risks posed by substances reported to man and the environment.

(d) Classification, packaging and labelling of dangerous substances for man and the environment.

All this, when such substances are placed on the internal market.

2. The following substances and preparations in the finished state, intended for the end user, which are regulated by their specific regulations, are excluded from the scope of this Regulation:

a) Medicines for human and veterinary use.

b) Cosmetics.

c) mixtures of substances in the form of residues.

d) Food products.

e) Animal food.

f) Pesticides.

g) The radioactive substances.

h) Other substances or preparations for which notification procedures already exist and the requirements of which are equivalent to those laid down in this Regulation.

They are also excluded from the scope of this Regulation:

i) The transport of dangerous goods by rail, road or inland waterway, sea or air.

(j) substances in transit under customs control, provided that they are not treated or processed.

Article 2. Definitions.

1. For the purposes of this Regulation it is understood by:

(a) Substances: the chemical elements and their compounds in the natural state, or those obtained by any production process, including the additives necessary to preserve the stability of the product and the impurities which result from the procedure used, excluding solvents that can be separated without affecting stability or modifying the composition.

(b) Prepared: mixtures or solutions composed of two or more substances.

c) Polymer: a substance consisting of molecules characterised by the sequence of one or more types of monomeric units and which includes a simple majority-weight of molecules containing at least three monomeric units with covalency bonds with another monomer unit or other reactant at least and constituted by less than a simple weight majority of molecules of the same molecular weight. Said molecules should be distributed in a molecular weight distribution in which the molecular weight differences can be mainly attributed to differences in the number of monomeric units. In the context of this definition, 'monomeric unit' means the reactated form of a monomer in a polymer.

(d) Notification: action by which documents relating to the substance are submitted to the competent authority, with the required information, corresponding to the obligation to make this notification to:

1. The manufacturer who places a substance on the market as such, or incorporated in a preparation, for substances manufactured in the Community.

2. No for substances which are introduced into the territory of the Community, for having been manufactured outside the Community, or for the purpose of re-importation from a third country: a natural or legal person established in the Community, which is responsible for the placing on the market of the substance as such or incorporated into a preparation; or for the person established in the Community who is designated by the manufacturer as its sole representative for the purposes of the presentation of the notification for a particular substance placed on the market as such or incorporated into a preparation.

(e) Notificant: a person who submits the notification to the competent authority in accordance with paragraph (d).

(f) Marketing: the supply or making available to third parties of the product. For the purposes of this Regulation, the importation into the customs territory of the Community shall be considered to be a marketing authorisation.

g) Scientific research and development: chemical research, analysis and scientific experiments carried out under controlled conditions; this definition includes the determination of the intrinsic properties of the performance and effectiveness, as well as scientific research related to product development.

h) Research and development of production: the further development of a substance during which its application areas are tested, using pilot production or production tests.

(i) EINECS: European Inventory of Existing Commercial Substances. This inventory sets out the definitive list of all substances which were originally on the Community market as at 18 September 1981.

j) ELINCS: European Inventory of Notified Chemical Substances.

k) Identification of hazards: identification of undesirable effects that a substance is intrinsically capable of.

l) Evaluation of the dose (concentration) /response (effect) ratio: the estimate of the relationship between the dose or the level of exposure to a substance and the incidence and severity of the effect.

ll) Assessment of the exposure: is the calculation of the concentrations or doses to which human populations or environmental compartments are or are to be exposed, as a result of the determination of emissions, transfer pathways and movement rates of a substance and its transformation or degradation.

m) Characterisation of risk: estimation of the incidence and severity of likely adverse effects on a human population or a compartment of the environment due to actual or anticipated exposure to the substance; include the "risk estimation", that is, the quantification of that probability.

n) Recommendations to reduce the risk: the recommendation of measures to reduce the risks that the human being and the environment have in place for the commercialization of the substance.

2. For the purposes of this Regulation, the following substances and preparations shall be considered dangerous:

(a) Explosives: solid, liquid, pasty, or gelatinous substances and preparations which, even in the absence of atmospheric oxygen, can react in an exothermic manner with rapid gas formation and which, in certain test conditions, detonate, deflagran quickly or under the effect of heat, in case of partial confinement, explosionan.

(b) Compounds: substances and preparations which, in contact with other substances, in particular with flammable substances, produce a strongly exothermic reaction.

c) Extremely flammable: liquid substances and preparations having an extremely low ignition point and a low boiling point, and gaseous substances and preparations which, at normal temperature and pressure, are flammable in contact with air.

d) Easily flammable: substances and preparations:

1. º That can be heated and inflamed in the air at room temperature without energy input, or

2. º solids that can be easily inflamed after a brief contact with a source of inflammation and continue to burn or be consumed after removal of the source, or

3. º liquids whose ignition point is very low, or

4. º That, in contact with water or wet air, release extremely flammable gases in dangerous quantities.

(e) Inflamables: liquid substances and preparations whose ignition point is low.

f) Very toxic: substances and preparations which, by inhalation, ingestion or skin penetration in very small quantities can cause acute or chronic effects and even death.

g) Toxics: substances and preparations which, by inhalation, ingestion or skin penetration in small quantities may cause acute or chronic effects and even death.

h) Harmful substances: substances and preparations which, by inhalation, ingestion or skin penetration, may cause acute or chronic effects and even death.

i) Corrosives: substances and preparations which, in contact with living tissues, may be destructive of them.

(j) Irritants: non-corrosive substances and preparations which, in short, prolonged or repeated contact with the skin or mucous membranes may cause an inflammatory reaction.

k) Sensitising: substances and preparations which, by inhalation or skin penetration, may cause a hypersensitivity reaction, in such a way that an exposure to that substance or preparation of such a substance Characteristic negatives.

l) Carcinogenics: substances and preparations which, by inhalation, ingestion or skin penetration, may cause cancer or increase its frequency.

m) Mutagenics: substances and preparations which, by inhalation, ingestion or skin penetration, may lead to hereditary genetic alterations or increase their frequency.

n) Toxics for reproduction: substances and preparations which, by inhalation, ingestion or skin penetration, may cause non-hereditary negative effects on the offspring, or increase the frequency of the offspring, or affect the negative form of the function or the reproductive capacity.

or) Dangerous for the environment: substances and preparations which present or may present an immediate or future hazard to one or more components of the environment.

CHAPTER II

Testing, assessment and classification of hazardous substances

Article 3. Tests.

The tests of the chemicals shall be carried out in accordance with the methods set out in Annex V to this Regulation. The determination of the physico-chemical, toxicological and ecotoxicological properties shall be carried out in accordance with Parts A, B and C respectively of that Annex.

However, for certain substances included in the EINECS, data may have been obtained with tests different from those mentioned above. In each case, consideration should be given, inter alia, to the following factors, the need to minimise the tests carried out on vertebrate animals, if the data are sufficient in relation to the general classification criteria and labelling, or if additional tests are to be carried out in accordance with that Annex V.

The laboratory tests will be carried out in accordance with Royal Decree 822/1993 of 28 May, laying down the principles of good laboratory practice and Royal Decree 223/1988 of 14 March 1988 on the protection of the animals used for experimentation and other scientific purposes.

Article 4. Risk assessment of new substances.

The assessment of actual or potential risks to man and the environment shall be carried out on the basis of the principles set out below:

1. Principles of risk assessment.

(a) The risk assessment shall include the identification of the hazard and, where appropriate, the assessment of the dose (concentration)-response (effect), the exposure assessment and the risk characterisation. This shall be done in accordance with the procedures laid down in paragraphs 2 and 3 of this Article.

(b) Regardless of paragraph (a) above, in relation to particular effects such as ozone depletion, to which paragraphs 2 and 3 of this Article cannot be applied, the risks associated with such effects shall be assessed. case by case and the competent authority shall attach a full description and justification of that assessment to the written report submitted to the Commission pursuant to paragraph 4.c) of this Article.

(c) When carrying out an exposure assessment, the competent authority shall take into account the human populations or the compartments of the environment in which it is reasonable to provide for exposure to the substance according to the information which on the latter is held, paying particular attention to storage, formulation in a preparation or other type of processing, use and disposal or recovery.

d) The risk assessment will lead to one or more of the following conclusions:

1. The substance does not pose problems immediately and it is not necessary to study it again until more information is available in accordance with Article 8 (2), Article 8 (2) and (4), or Article 14 (1) of this Regulation. Regulation.

2. The substance poses problems, in which case the competent authority will decide what additional information is needed to review the assessment, but will defer requesting that information until the amount marketed reaches the substance. the tonnage threshold referred to in Article 7 (2) and Article 8 (2) and (4) of this Regulation.

3. The substance poses problems and additional information should be required immediately.

4. The substance poses problems and the competent authority should immediately make recommendations to reduce the risk.

(e) Where the risk assessment indicates that the conclusions of points 2. 3. (3) or 4. (d) of this Article are applicable, the notifier may be informed of the findings by the competent authority, dandosele the opportunity to comment on them and to provide additional information. The competent authority shall use any relevant information to review the risk assessment before it is sent to the Commission.

(f) The competent authority, when making recommendations to reduce the risk due to a substance, shall take into account the possibility that the reduction of exposure of certain environmental compartments or populations Humans may increase the exposure of other environmental compartments or human populations.

g) The recommendations made by the competent authority to those responsible for substances, in order to reduce the risk of substances, may include, inter alia:

1. Amendments to the classification, packaging or labelling of the substance proposed by the notifier in the notification submitted pursuant to Article 7 (1) and Article 8 (1) or (3) of this Regulation. Regulation.

2. No amendments to the safety data sheet, as proposed by the notifier in the notification submitted pursuant to Article 7 (1) and Article 8 (1) or (3) of this Regulation.

3. No amendments to the recommended methods and precautions or emergency measures, as set out in Sections 2.3, 2.4 and 2.5 of Annexes VII A, VII B, VII C or VII D, proposed by the notifier in the documentation the technical nature of the notification submitted pursuant to Article 7 (1) and Article 8 (1) or (3) of this Regulation.

(h) Furthermore, the competent authority for the risk assessment of substances may transmit to the bodies of the Autonomous Communities responsible for monitoring and monitoring the necessary advice or guidance for the the adoption of the most appropriate measures for the protection of the population and the environment.

2. Risk assessment: human health.

(a) A risk assessment shall be carried out by the competent authority in each of the substances notified in accordance with Article 7 (1) and (1) or (3) of this Regulation; the first stage of that assessment consist of the identification of the hazards related to at least the properties and the adverse effects specified in Part 1 of Annexes X.A and X.B. Once the hazards have been identified, the competent authority shall proceed to the the following series of measures, which will be carried out in accordance with the guidelines set out in Part 2. X.A and X.B attachments:

1. ° Evaluation of the dose (concentration) response (effect), where appropriate.

2. Evaluation of exposure for any of the human populations (i.e. workers, consumers and the population indirectly exposed to the environment) who may be exposed to the substance.

3. º Risk Characterization.

b) As an exception from the previous paragraph (a):

1. No If appropriate tests have been carried out to identify the hazards arising from an effect or a particular property and the results are not classified according to this Regulation, it is not mandatory. include in the assessment of the risk for that effect or property, the measures of points 1, 2, 2 and 3 of the previous paragraph (a) in which case the conclusion of paragraph 1 (1) (d) of this Article shall apply, unless there are other reasons reasonable of concern, and

2. If the appropriate tests have not yet been carried out to identify the hazards arising from an effect or a particular property, this effect or property shall not be taken into account in the risk assessment, unless there are other risks. reasonable grounds for concern.

3. Risk assessment: environment.

(a) The competent authority shall carry out an assessment of the risk related to the environmental effects of each substance notified in accordance with Article 7 (1) and Article 8 (1) or (3) of this Regulation; First stage of such assessment shall be the identification of the hazards. Once such identification has been made, the competent authority shall proceed to the sequence of the following measures, which shall be carried out in accordance with the guidelines set out in Annex X.C:

1. ° Evaluation of the dose (concentration) response (effect), where appropriate.

2. Evaluation of exposure in the environmental compartments (aquatic environment, terrestrial and air) that may be exposed to the substance.

3. º Risk Characterization.

b) As an exception to the previous paragraph (a):

1. In the case of substances notified in accordance with Article 7 (1) of this Regulation but not classified as hazardous to the environment, it shall not be necessary to include in the risk assessment. measures of points 1, 2, 2 and 3 of paragraph 1 (a) and the conclusion of paragraph 1 (1) (d) of this Article shall apply, unless there are reasonable grounds for alarm, and

2. In the case of substances notified in accordance with Article 8 (1) or (3) of this Regulation, if there is insufficient data to determine whether classification as hazardous to the environment is appropriate, The identification of the hazards shall lead to the question of whether or not there are any grounds for alarm in relation to the environmental effects on the basis of other data, e.g. data on the physicochemical and toxicological properties. Unless there are reasonable grounds, it shall not be necessary to include in the risk assessment the measures of points 1, 2, 2 and 3 of paragraph (a) above and the conclusion of paragraph 1 (1) (d) of this Article shall apply.

4. Conclusions of the risk assessment.

(a) Once the risk assessment has been carried out in accordance with paragraphs 2 and 3 of this Article and Annexes X.A, X.B and X.C, the competent authority, in accordance with Annex X.D, shall determine which of the four conclusions of the paragraph (1) (d) of this Article is applicable to you and shall take the measures described in paragraph 1 (e) of this Article if necessary.

(b) The risk assessment carried out in accordance with paragraphs 2 and 3 of this Article, and with Annexes X.A, X.B and X.C, shall be reviewed and, if necessary, amended in the light of the additional information received under the Article 7 (2), (2) and (4) of Article 8, Article 14 and Article 16 of this Regulation or other sources.

(c) Once the risk assessment has been carried out in accordance with paragraphs 2 and 3 of this Article and drawn up in accordance with the above paragraphs, the competent authority shall prepare a written report containing the less the information set out in Annex X.E. This report shall be sent to the EC Commission and updated after each review of the assessment in the light of the additional information. The updated report shall be sent to the Commission.

(d) The notifier may request a copy of the risk assessment report or of any revisions to it.

Article 5. Classification of substances.

1. The classification of the substances shall be carried out on the basis of their intrinsic properties, in accordance with the categories defined in Article 2 (2). When the substances are classified, the impurities shall be taken into account when their concentration exceeds the limits provided for in paragraph 4 of this Article and in Article 3 of the Regulation on the classification, packaging and labelling of dangerous preparations.

2. The general principles for the classification and labelling of substances and preparations shall be applied in accordance with the criteria set out in Annex VI to this Regulation, unless specific provisions are contrary to the rules. regulatory for dangerous preparations.

3. The list of dangerous chemicals contained in Annex I to this Regulation are classified and labelled in accordance with the general principles set out in paragraphs 1 and 2 above.

4. The dangerous substances listed in Annex I shall, where appropriate, be accompanied by the specification of the concentration limits or parameters which enable the health hazards and the environment of the preparations to be weighed. containing such dangerous substances or substances containing other dangerous substances as impurities.

5. Manufacturers, distributors and importers of dangerous substances not listed in Annex I but listed in the EINECS shall carry out appropriate investigations in relation to the properties of such substances, and package and provisionally label the same in accordance with Articles 18 to 21 and the criteria set out in Annex VI.

Article 6. Obligations for the placing on the market of substances.

1. Without prejudice to Article 13, substances, in their natural state or incorporated in preparations, may be marketed only if:

(a) They have complied with the notification requirements to the competent authority in accordance with the provisions of this Regulation.

(b) Meet the packaging and labelling conditions contained in this Regulation, in accordance with the criteria set out in Annex VI and in the light of the results of the tests referred to in Annexes VII and VIII, except in the case of preparations which are the subject of other specific provisions.

(c) Meet the obligations relating to the safety data sheet in accordance with the terms set out in Article 23.

2. The labelling and packaging conditions described in paragraph 1. (b) above shall be required for substances as long as they are not included in Annex I or until their inclusion is refused.

CHAPTER III

Notification of new substances

Article 7. Full notification.

1. Without prejudice to Article 1 (2), Article 8 (1), Article 13 and Article 16 (1), any notifier of a substance shall be required to submit to the competent authority a report on the application of the provisions of Article 16 (1). notification containing the following documents:

(a) A technical-scientific report containing the information necessary for the assessment of foreseeable, immediate or future hazards, which the substance may present for man and the environment. That report shall contain at least the data and results of the tests referred to in Annex VII A and VII D where appropriate, as well as a complete and detailed description of the tests and the methods applied or their bibliographic references.

(b) A statement on the adverse effects of the substance in accordance with the intended uses.

(c) A proposal for the classification and labelling of the substance in accordance with this Regulation

and

d) Only in the case of hazardous substances, a proposal for a safety data sheet.

(e) Where the manufacturer is established outside the internal market, the notifier shall, where appropriate, attach a declaration by the manufacturer that he has been designated as his sole representative, to the object of the notification of the substance concerned.

(f) A statement by the notifier when, duly supporting it, he does not wish to have Article 15 (2) applied to it for a maximum period which may not exceed one year from the date of the notification. notification.

g) The notifier may also provide the authority with a first risk assessment, carried out by the notifier, in accordance with the principles referred to in Article 4.

2. Without prejudice to Article 14, the notifier of an already notified substance shall inform the competent authority:

(a) When the quantity of the substance marketed reaches 10 tonnes per year and manufacturer, or where the total quantity marketed reaches the figure of 50 tonnes per manufacturer. The notifier shall inform the competent authority and is within a time limit to be determined by the notifier, which may require all or some of the tests specified in Annex VIII level 1 to this Regulation to be carried out.

(b) Where the quantity of the substance marketed reaches 100 tonnes per year and manufacturer or when the total quantity marketed reaches the figure of 500 tonnes per manufacturer. The notifier shall inform the competent authority and is within a time limit to be determined by the notifier, requiring the tests specified in Annex VIII level 1 to be carried out, unless the notifier justifies that a test or study is not appropriate. or that an alternative scientific study or study would be more appropriate.

(c) When the quantity of substance marketed reaches 1,000 tonnes per year and manufacturer or when the total quantity marketed reaches the figure of 5,000 tonnes per manufacturer. The notifier shall inform the competent authority, which shall draw up a programme of tests in accordance with Annex VIII level 2, to be carried out by the notifier within a time limit to be determined by the competent authority.

3. Where additional tests are carried out in accordance with paragraph 2 or on a voluntary basis, the notifier shall submit the results of the studies to the competent authority. Article 8. Simplified Notification.

1. Without prejudice to Article 1 (2), Article 13 (1) and Article 16 (1), any notifier intending to place a substance on the market in quantities of less than 1 tonne per year and Manufacturer shall submit to the competent authority a notification containing the following documents:

(a) A technical-scientific report containing the information necessary for the assessment of foreseeable, immediate or future hazards, which the substance may present for man and the environment. That report shall contain at least the data and results of the tests referred to in Annex VII B and VII D, as appropriate, as well as a complete and detailed description of the tests and methods applied or their bibliographic references.

(b) All documents contained in paragraphs (b), (c), (d), (e), (f) and (g) referred to in Article 7.1.

2. Before the quantity of the substance placed on the market reaches one tonne per year and manufacturer or before the total quantity marketed reaches 5 tonnes per manufacturer, the notifier shall submit to the competent authority a notification complete in accordance with the provisions of Article 7.

3. Where the quantities placed on the market are less than 100 kilograms per year and manufacturer, the notifier shall include the information and the results of the tests referred to in Annex VII C and VII D where appropriate, without prejudice to Article 16 (1).

4. Before the quantity of the substance placed on the market reaches 100 kilograms per year and manufacturer or before the total quantity marketed reaches 500 kilograms per manufacturer, the notifier shall provide the competent authority with the additional information necessary to complete the technical report in accordance with Annex VII B and VII D where appropriate.

5. The substances notified in accordance with paragraphs 1 and 3 above shall be provisionally packaged and labelled in accordance with Articles 18 to 21 and with the criteria laid down in Annex VI.

When it is not possible to comply with the labelling conditions in accordance with Article 19, the label must bear the words "Caution: no complete tests of this substance have been carried out", in addition to the labelling resulting from the tests already performed.

Article 9. Substances already notified (ten year rule).

When a substance has been notified, and the documents required for it have been submitted ten years in advance, the notifier shall not be obliged to provide the information referred to in the Articles 7 and 8 for the technical reports referred to in Annex VII A, VII B, VII C or VII D derogation from the provisions of paragraphs 1 and 2 of those Annexes.

Article 10. Marketing of the notified substances.

1. In the case of the complete notifications provided for in Article 7 (1), the competent authority shall have a period of 60 days from the date of notification of the substance for the formulation of the observations it considers to be required.

After the 60-day period, the notification shall be deemed to comply with the regulatory requirements laid down, and the substance may be placed on the market. Within this period, the period of 20 days shall be included for the issue of the certification provided for in Article 44 of Law No 30/1992 of 26 November 1992, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, certification which may be requested by the notifier after 40 days after the notification of the substance has been submitted. All this, without prejudice to the remaining obligations for the competent authority, as provided for in Article 16.2.

If the competent authority considers that the content of the notification does not comply with the provisions of this Regulation, and in accordance with the provisions of Article 16.2, it shall inform the notifier in writing, manifest the documentation or requirements that would be necessary for the positive assessment of the dossier.

Where the notifier submits new documentation, in compliance with the requirements of the competent authority, the latter shall have a new period of 60 days for the study of the same, where the provisions of this Regulation are applicable. in the previous point.

2. In the case of simplified notifications provided for in Article 8 (1) or (3), the competent authority shall have a period of 30 days, from the date of notification of the substance, for the formulation of the observations which have been made. Consider necessary. After that period, the notification shall be deemed to comply with the established regulatory requirements and the substance may be placed on the market, without prejudice to the obligations of the competent authority in accordance with the Article 16.3.

If the competent authority considers that the content of the notification does not comply with the provisions of this Regulation, and in accordance with the provisions of Article 16.3, it shall inform the notifier in writing, manifest the documentation or requirements that would be necessary for the positive assessment of the dossier.

Where the notifier submits new documentation, in compliance with the requirements of the competent authority, the latter shall have a new period of 30 days for the study of the same, where the provisions of this Regulation are applicable. in the previous point.

3. By way of derogation from the above paragraphs, the notified substances may under no circumstances be placed on the market before 15 days have elapsed since the competent authority has received the notification file, where the notifier receives within that time the written communication with the acceptance of the notified substance.

Article 11. Control of the quantities of a substance to be introduced into the territory of the Community from third countries.

In the case of substances manufactured outside the internal market, or which have acceded to it as a result of re-importation from third countries, and there is more than one notification on a substance produced by the same manufacturer, the Commission and the competent authority shall determine the cumulative annual quantities placed on the internal market on the basis of the information communicated in accordance with Article 7 (1), Article 8 and Article 14.

The obligation to carry out supplementary tests in accordance with Article 7 (2) is collectively referred to by all the notifiers.

Article 12. Polymers.

The technical reports contained in the notifications referred to in Article 7 (1) and Article 8 (1) for polymers shall include the data and results of the studies referred to in the Annex. VII D of this Regulation.

CHAPTER IV

Exemptions from Notification

Article 13. Exemptions.

1. They are exempted from the notification procedure set out in Articles 7, 8, 14 and 15:

(a) The substances listed in the EINECS.

(b) Additives and substances for the exclusive use in animal nutrition.

(c) Substances used exclusively as food additives and as flavourings in foodstuffs.

(d) The active ingredients used exclusively for medicinal products for human and veterinary use, without the inclusion of intermediate chemicals.

e) The active ingredients used exclusively for plant protection products, and

(f) Substances used exclusively for other categories of products for which there are notification or approval procedures identical to those required by this Regulation.

2. The substances listed below shall be deemed to have been notified in accordance with this Regulation where the following conditions are met:

(a) Polymers, other than those containing 2 per 100 or more in a linked form, of a substance not listed in the EINECS.

(b) Substances placed on the market in quantities of less than 10 kilograms per manufacturer per year, provided that the manufacturer/importer complies with all the information referred to in paragraphs 1 and 2 of Annex VII C.

(c) Substances placed on the market in limited quantities, which in any case do not exceed 100 kilograms per manufacturer and year, intended exclusively for the purposes of research and scientific development carried out under control conditions.

Any manufacturer or importer benefiting from this exemption must keep a register with the name of the substance, the labelling data, the quantities and the list of customers; this information must be available to the competent authority where the manufacture, import or scientific research and development activities are carried out.

(d) Substances placed on the market for research and production development in quantities limited to the needs of such research and development, with a restricted number of registered customers. These substances may be covered by this exemption for a period of one year, provided that the manufacturer or the importer communicates the name, the data used in the labelling, the quantity of the substance, the justification for the quantity, the list of of the customers and the research and development programme to the competent authority in which the manufacture, import or research and development has been carried out, provided that it complies with the provisions which it has adopted for that purpose. authority, which may request the information required by Article 8.

After one year, these substances must be notified. The manufacturer or importer shall provide a guarantee that the substance or the preparation to which it is incorporated shall be handled only by the customer's staff under conditions of control and that at no time shall the substance or the preparation shall be made available to the general public. Furthermore, if the competent authority considers that there may be an unacceptable risk to man and the environment, it may extend the restriction referred to above including any product containing the new substance, and which has been manufactured during the research and development of production.

The one-year exemption period may be extended to one more year in exceptional circumstances, if the notifier can justify the need for such an extension to the competent authority.

3. Provided that the hazardous properties of the substances referred to in paragraph 2 are known, the manufacturer or his representative must package and label the substances provisionally, in accordance with the rules laid down in Articles 18 to 21. and with the criteria set out in Annex VI.

Where it is not possible to label them because the results of the tests referred to in Annex VII A and VII D where appropriate are incomplete, the label, in accordance with the principles laid down in Article 19, shall be In addition to the labelling derived from the tests already carried out: "Caution: no complete tests of this substance have been carried out".

4. Where one of the substances referred to in paragraph 2, labelled in accordance with Article 19, is very toxic, toxic, mutagenic, toxic for reproduction or carcinogenic, the manufacturer or importer of the substances referred to in Article 19 shall put in knowledge of the competent authority all information as set out in points 2.3, 2.4 and 2.5 of Annex VII A, and where appropriate as set out in Annex VII D. The acute toxicity data shall also be provided if the data are available to the competent authority. same.

CHAPTER V

New information and subsequent notifications of a new substance

Article 14. Back information.

1. Any notifier of a substance already notified in accordance with Article 7 (1) or Article 8 (1) shall, on its own initiative and under its responsibility, inform the competent authority in writing of:

(a) Variations in the annual or total quantities placed on the internal market by the single representative or, where appropriate, by the single representative.

b) New knowledge about the effects that the substance can produce on man and/or on the environment.

(c) New uses for which the substance of which it is reasonable to assume that the notifier is already aware is reasonable.

(d) Any modification concerning the composition of the substance as set out in Annexes VII A, VII B or 1.3 of Annex VII C and in Annex VII D.

e) Any changes to your situation as a manufacturer or importer.

2. Any importer of a substance produced outside the internal market and notified in advance by a single representative shall ensure that the representative has up-to-date information on the quantities of the substance imported by him. on the internal market.

Article 15. Subsequent notifications of the same substance and procedure to avoid repetition of tests on vertebrate animals.

1. Where a substance has already been notified in accordance with Article 7 (1) or Article 8 (1), the competent authority may decide that the following notifier of the same substance, as regards the provisions of Article 7 (1) of Regulation (EC) No 121/2013, shall be notified to the competent authority. 3, 4 and 5 of Annexes VII A, VII B and VII D and Annex VII C (3) and (4) may be submitted to the results of the tests and studies reported by the first notifier, if the subsequent notifier demonstrates that the substance reported by second time is the same as the first, and that the degree of purity and the nature of the impurities also coincide. The first notifier shall give his written agreement to the use of the tests or studies communicated by him prior to such use.

2. Before testing on vertebrate animals, for the purpose of submitting a notification in accordance with Article 7 (1) and Article 8 (1) and without prejudice to the provisions of paragraph 1 of this Article, Article, future notifiers shall request the following information from the competent authority of the Member State in which they intend to submit the notification:

a) If the substance they intend to notify has already been reported or not.

b) The name and address of the first notifier.

This application shall be accompanied by supporting evidence showing that the future notifier intends to place the substance on the market. It shall also indicate the quantities it intends to place on the market.

For the assumption that:

(a) The competent authority receiving the notification is assured that the future notifier intends to place the substance on the market in the quantities indicated.

b) The substance has already been notified previously, and

(c) The first notifier has neither requested nor been granted a temporary exemption from the provisions of this Article, the competent authority shall provide the notifier with the name and address of the first notifier. The notifier shall also inform the notifier of the name and address of the notifier.

The first notifier and the future notifier shall take all necessary measures to reach an agreement on the exchange of information and avoid the repetition of tests on vertebrate animals.

3. Notifiers of the same substance which have reached an agreement to exchange information concerning Annex VII, as set out in paragraphs 1 and 2, shall also take all necessary measures to reach an agreement in accordance with Article 4 (1) and (2). concerning the exchange of information on tests carried out on vertebrate animals in accordance with Article 7.2.

4. If, in spite of the provisions of paragraphs 2 and 3, the notifiers and the future notifiers of the same substance continue to be without agreement to share the information, the competent authority may, as regards the notifiers and to the future notifiers, to establish measures to commit the notifiers and the future notifiers to share the information in order to avoid a repeat of tests on vertebrate animals and to determine the procedure for the use of the information, including provisions on the temporary derogation from Article 7 (1) (f) and the reasonable balance between the interests of the parties concerned are referred to.

CHAPTER VI

Functions of the competent authority. Data confidentiality

Article 16. Functions of the competent authority.

1. The competent authority shall examine the information referred to in Articles 7 to 15 and shall decide whether it complies with the provisions of this Regulation and

:

(a) Order, if necessary to assess the risk, further information and/or new tests for the verification or confirmation of the substances or their processing products, which have been the subject of notification or (a) to request the information contained in Annex VIII in advance of the provisions of Article 7 (2).

b) Collect the samples required for control.

(c) Ask the notifier to supply the quantities of the notified substance deemed necessary to carry out the verification tests.

d) Adopt appropriate measures for safer use of substances.

For substances notified in accordance with Article 7 (1) and Article 8 (1) and (3), the competent authority receiving the notification shall carry out an assessment of the risks in accordance with the provisions of the Article 4. The assessment shall be updated regularly on the basis of the additional information provided by the notifier.

2. A period of 60 days from the receipt of the complete notification shall be established, in which the competent authority shall inform the notifier of the course which has been given to it in writing, whether or not it is in conformity with the present Regulation.

In the absence of communication by the Competent Authority, the provisions of Article 10.1 shall apply.

If the file is accepted, the competent authority shall at the same time communicate to the notifier the official number that has been assigned to its notification.

Where the dossier is not accepted, the competent authority shall require the notifier of the additional information necessary for the notification dossier to comply with this Regulation.

3. A period of 30 days shall be established from the receipt of the simplified notification, in which the competent authority shall assess whether such notification complies with this Regulation.

If the file is accepted, the authority shall at the same time communicate to the notifier the official number that has been assigned to its notification.

Where the dossier is not accepted, the competent authority shall require the notifier of the additional information necessary to ensure that the notification dossier complies with this Regulation.

4. The competent authority shall calculate the cumulative annual quantities of substances manufactured outside the internal market in accordance with Article 11. Where the thresholds set out in Article 7 (2) are reached, the competent authority shall establish contact with each of the notifiers and communicate the identity of the other notifiers with a view to the collective responsibility of the the notifiers.

5. The competent authority participates in the system of exchange of notification information, established between the Commission and the Member States.

6. The competent authority shall ensure the confidentiality of data relating to the commercial exploitation and manufacture of the substances.

7. For the purposes of the study of notifications, the competent authority may seek the collaboration and advice of scientific experts and, where appropriate, set up specialised working groups.

Article 17. Data confidentiality.

1. The notifier shall indicate which data must be kept secret, as described in Articles 7, 8 and 14, and the dissemination of which may be detrimental to him in the industrial or commercial field and for which he requires the maintenance of secrecy in relation to any person. other than the competent authority. In such a case, such a requirement shall be justified.

The following data cannot be protected by commercial and industrial secrecy:

a) The commercial name of the substance.

b) The name of the manufacturer and the notifier.

(c) The physical-chemical data of the substance in relation to paragraph 3 of Annex VII.

d) The possibilities of making the substance harmless.

e) The summary of toxicological and ecotoxicological tests.

(f) The degree of purity of the substance and the identity of the impurities and/or additives known as hazardous according to the criteria of Article 2 (2), if it is essential for classification and labelling and for their inclusion in Annex I.

(g) The methods and precautions recommended in paragraph 2.3 of Annex VII and the emergency measures referred to in paragraphs 2.4 and 2.5 of Annex VII.

h) The data that appears on the security data tab, and

(i) In the case of substances listed in Annex I, analytical methods for detecting a dangerous substance released into the environment and determining the degree of direct exposure of the human being.

If the notifier, the manufacturer or importer makes public the information previously considered as confidential, it shall inform the competent authority.

2. The competent authority shall decide which information is protected by industrial and commercial secrecy in accordance with paragraph 1 above.

Information deemed confidential by the authority shall be treated as such by the Commission and by the other competent authorities of the Member States and vice versa.

3. However, in the case of criminal administrative or criminal proceedings initiated in the exercise of the function or control of the substances placed on the market, such information may be brought to the attention of the persons directly concerned. interested in such procedures.

4. The notified substances, which are not classified as dangerous according to the criteria of this Regulation, may be listed under their trade name on the European list of 'ELINCS' notified chemical substances, at the request of the competent authority and for a maximum period of three years. However, if the authority considers that the publication of the chemical name in accordance with the nomenclature of the IUPAC may reveal information concerning the placing on the market or manufacture, the substance may be included exclusively by its trade name during the period that the authority considers appropriate.

If requested by the authority, the hazardous substances shall be listed in the ELINCS only under their trade name until they are listed in Annex I.

CHAPTER VII

Packaging, Labelling, and Security Data Tab

Article 18. Packaging.

1. Dangerous substances may be placed on the market only if their packaging complies with the following conditions:

a) They will be designed and manufactured in such a way as not to be possible loss of content. This condition will not apply when prescribing special security devices.

(b) The materials with which the packaging is manufactured and the closures must not be attacked by the contents, nor shall they form with the latter dangerous combinations.

(c) Packaging and closures must be strong and solid in order to prevent loosening and must respond reliably to maintenance requirements.

d) The containers with a reusable locking system must be designed so that the container can be closed several times without loss of its contents.

e) Whatever capacity, containers containing substances sold to the general public or made available to the public, labelled as "very toxic", "toxic" or "corrosive", must have a closure of safety for children and to bring an indication of detectable danger to the touch.

(f) Any capacity, containers containing substances sold to the general public or made available to the public, labelled as "harmful", "extremely flammable" or "easily flammable", must be carry an indication of detectable danger to the touch.

2. The technical specifications for child safety closures, and devices to detect hazards to the touch, shall comply with the rules set out in Annex IX to this Regulation.

Article 19. Tagged.

1. Dangerous substances may be placed on the market only when the labelling of their packaging, in a legible and indelible manner, is at least in the official Spanish language of the State, the following conditions:

(a) The name of the substance, with one of the names listed in Annex I. Where the substance is not in that Annex, it shall be given the name used in an internationally recognised nomenclature.

(b) The full name and address, including the telephone number, of the person responsible for placing the market on the internal market, either the manufacturer, the importer or the distributor.

(c) The symbols and hazard statements in accordance with Annex II. The symbols must be printed in black on an orange yellow background.

For the dangerous substances listed in Annex I, the symbols and hazard statements listed in that Annex should be used. For dangerous substances not listed in Annex I, the symbols and hazard statements shall be attributed in accordance with the rules laid down in Annex VI.

When a substance must carry more than one symbol, the following rules will be followed:

1. The obligation to place the symbol T makes the symbols X and C optional, unless otherwise specified in Annex I,

2. The obligation to put the C symbol makes the X symbol optional, and

3. The obligation to put the symbol E converts the symbols F and O.

(d) The standard phrases indicating the specific risks arising from the hazards of the substance (R phrases) shall be in accordance with the indications in Annex III.

For the dangerous substances listed in Annex I, the R-phrases indicated in that Annex shall be used. For substances not listed in Annex I, the R phrases shall be attributed according to the rules set out in Annex VI.

(e) The standard phrases indicating the precautionary advice in relation to the use of the substance (S) shall be in accordance with the indications in Annex IV.

For the dangerous substances listed in Annex I, the S-phrases as set out in that Annex shall be used. For dangerous substances not listed in Annex I, the S-phrases shall be attributed in accordance with the rules set out in Annex VI.

f) The EEC number, if assigned. This number will be obtained from the "EINECS" or the "ELINCS".

(g) The substances listed in Annex I shall also bear the phrase "EEC label" on the label.

2. In the case of irritable, easily flammable, flammable or oxidising substances, it is not necessary to indicate the R and S phrases when the contents of the package do not exceed 125 millilitres. This rule shall also apply to harmful substances of the same content, where they are not sold to the public in general.

3. Indications such as 'non-toxic', 'harmless' or any other analogue indication may not appear on the label or packaging of the substances covered by this Regulation.

Article 20. Application of the labelling conditions.

1. Where the particulars required by Article 19 are given on a label, the label shall be affixed solidly on one or more sides of the package so that the particulars can be read horizontally when the package is in position normal.

The dimensions of the label must respond to the following formats:

Container/Format Capacity-(In millimeters)

Less than or equal to at least 3 litres/52 x 74.

Top 3 litres and less than or equal to 50 litres/74 x 105 at least.

Top 50 litres and less than or equal to 500 litres/105 x 148 at least.

Top 500 litres/148 x 210 at least.

Each symbol must occupy at least one-tenth of the surface of the label, in no case less than 1 cm. The label shall be attached to the packaging containing the substance directly on its entire surface. These areas shall be intended solely for the purposes of containing the information required by this Regulation and, where appropriate, supplementary hygiene or safety indications.

2. The label shall not be required where the particulars provided for in the preceding paragraph are visible on the packaging itself.

3. The presentation and colour of the label and, in the case of paragraph 2, of the package shall be such that the hazard symbol and the background on which it is printed clearly stand out.

4. The information referred to in Article 19 shall contain the label, stand out on the bottom and shall be of a sufficient size and shall be so spaced as to be easily read. Annex VI contains specific provisions concerning the presentation and format of this information for certain substances.

5. The labelling requirements shall be deemed to be fulfilled for the purposes of this Regulation:

(a) Where packaging containing one or more internal packaging is labelled in accordance with international standards for the transport of dangerous substances and the internal packaging or internal packaging is labelled in accordance with this Regulation.

b) In the case of a single package:

1. Where the label bears a label in accordance with international standards for the transport of dangerous substances and paragraphs (a), (b), (d), (e), (f) and (g) of Article 19 (1).

2. ° When considered appropriate for special types of packaging, such as portable gas cylinders, in accordance with the specific requirements set out in Annex VI.

Article 21. Exceptions to the labelling and packaging requirements.

1. Articles 18, 19 and 20 above shall not apply to the provisions governing ammunition and explosives placed on the market to produce a pyrotechnic or explosion practical effect.

2. Where the packaging is very small or in such a way that it does not permit the use of a label which can comply with Article 20 (1) and (2), the labelling required in Article 19 may be applied in a different manner. appropriate, provided that the competent authority has previously been brought to the attention of the competent authority 60 days prior to its placing on the market.

3. Packaging of dangerous substances, which are not "explosive", "very toxic" or "toxic", may be exempted from the labelling requirement or be made in a manner other than that required by Articles 19 and 20, in the case of such quantities containing such quantities. reduced which cannot be a danger to persons handling such substances or to third parties, provided that they are previously known to the competent authority 60 days before they are placed on the market.

4. Where the packaging of substances, "explosive", "very toxic" or "toxic" is very small or in such a way that they do not permit the labelling provided for in Articles 19 and 20, they may be labelled in any other appropriate form, provided that there is no danger to persons handling such substances or to third parties, provided that they are previously known to the competent authority 60 days before they are placed on the market.

In the exceptions referred to in paragraphs 2, 3 and 4, symbols, hazard statements, R phrases or S phrases other than those laid down in this Regulation may not be used.

Article 22. Advertising.

In accordance with the provisions of Article 8 of Law 34/1988 of 11 November 1988, General of Advertising, and Article 27 of Law 14/1986, General of Health, all advertising on substances included in one or more of these substances is prohibited. a number of the categories referred to in Article 2 (2) where the category or categories concerned are not mentioned.

Article 23. Security Data Tab.

1. In order to adopt a system of information aimed primarily at professional users to enable them to take the necessary measures for the protection of health and safety at the workplace, the person responsible for the placing on the market of a dangerous substance must have a safety data sheet at the time of placing on the market. A copy of the same shall be submitted to the Ministry of Health and Consumer Affairs, which shall keep it at the disposal of the Autonomous Communities that request it.

Such a token may be communicated on paper or electronically.

The person responsible for placing a dangerous substance on the market, whether the manufacturer, the importer or the distributor, must provide the recipient, who is a professional user, with a safety data sheet in the the time of the first delivery of the same or even earlier, in which the information specified in paragraph 2 of this Article is included.

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 new dated version, known as the 'Review ... (date)', will be provided free of charge to all previous recipients and would have received the substance in the preceding 12 months. It shall also be forwarded to the Ministry of Health and Consumer Affairs.

It shall not be mandatory to provide the safety data sheet in case the dangerous substances placed on the market are accompanied by sufficient information to enable the user to take the necessary measures in relationship with the protection of health and safety. However, the safety data sheet must be provided if the professional user so requests.

3. The safety data sheet referred to in paragraph 1 above shall at least be written in the official Spanish language of the State and shall include the following headings:

(a) Identification of the substance and the person responsible for placing it on the market.

b) Composition/information about the components.

c) Identification of hazards.

d) First aid.

e) Fire fighting measures.

f) Measures to be taken in case of accidental dumping.

g) Manipulation and storage.

h) Exposure/individual protection controls.

i) Physical-chemical properties.

j) Stability and reactivity.

k) Toxicological information.

l) Ecological information.

m) Considerations regarding removal.

n) Information regarding transport.

n) Regulatory information, and

o) Other information.

The person responsible for placing the substance on the market shall provide the information corresponding to these headings in accordance with the explanatory notes set out in Annex XI to this Regulation. The safety data sheet must be dated.

CHAPTER VIII

Administrative competencies

Article 24. Competence determination.

1. Competence of the State Administration.

(a) In accordance with Article 40.1, 5 and 6 of Law 14/1986, General Health, the Ministry of Health and Consumer Affairs shall be competent authority as regards the determination and development of the requirements of classification, packaging, labelling and safety data sheets of dangerous substances, as well as actions relating to the procedure for the notification and risk assessment of new substances and for the verification or approval of such substances substances which, where appropriate, may be carried out prior to their placing on the market.

b) In the exercise of these powers, the Ministry of Health and Consumer Affairs will coordinate its actions with the Ministries of Labour and Social Security, Industry and Energy and Public Works, Transport and the Environment, and with the other bodies of the public authorities, in order to ensure that the provisions of this Regulation are applied correctly. Likewise, and in accordance with the provisions of Article 4.1.c) of Law 30/1992, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, it shall provide those authorities with the information they need for the exercise of their duties. of their functions.

(c) Corresponding to the Ministry of Health and Consumer Affairs, the exercise of the precise activities for the correct performance of the competencies that it corresponds to.

2. Powers of the Autonomous Communities.

It shall be for the competent bodies of the Autonomous Communities to monitor, inspect and monitor the proper compliance with this Regulation with regard to substances and preparations placed on the market in their respective territories, as well as the exercise of sanctioning power where appropriate.

3. Work on safety and hygiene at work.

The provisions of this Regulation shall not affect the ability of competent bodies in matters of safety and hygiene at work to lay down the requirements necessary to ensure the protection of workers. during the use of the dangerous substances, provided that this does not lead to changes in the classification, packaging or labelling of dangerous substances with regard to the provisions laid down in this Regulation.

Article 25. Exchange of information.

1. The Ministry of Health and Consumer Affairs shall provide the Autonomous Communities with the advice, guidance, information or any other element available to them so that they can properly exercise their inspection and surveillance functions.

You will also be able to implement the measures that are most appropriate to achieve the effective coordination of the actions that correspond to the Autonomous Communities.

2. Without prejudice to the coordination and cooperation measures to be established, the authorities of the Autonomous Communities responsible for monitoring the proper implementation of this Regulation shall report annually to the Ministry of Health and Consumer Affairs, the activities they undertake to ensure the implementation of this Regulation.

Article 26. Competence for request for information.

1. In order to respond to any request for a medical order, the Ministry of Health and Consumer Affairs and the corresponding bodies of the Autonomous Communities may ask the person responsible for marketing the information relating to the dangerous substances placed on the market, including their chemical composition. Similarly, in case of urgency, such information may be requested by any authority which has to deal with such a situation. In any event, the confidentiality of the data supplied with such a character shall be ensured. For all of this, any additional provisions deemed appropriate may be made, where appropriate.

2. A system of information for the prevention and treatment of poisonings or accidents caused by dangerous substances shall be established by Royal Decree.

Article 27. Safeguard clause.

1. Where the Ministry of Health and Consumer Affairs has clear evidence that a substance placed on the market, while complying with the requirements of this Regulation, constitutes a hazard to health or the environment on the grounds of its classification, packaging or labelling, may subject it to special conditions of inspection, a new provisional classification of the substance or, if necessary, prohibit the placing on the market of that substance. The Ministry of Health and Consumer Affairs shall immediately inform the European Union and the other Member States of the reasons for such a decision.

2. The Ministry of Health and Consumer Affairs shall inform the manufacturer or the person responsible for placing the substance on the market of the measures taken in the course of the duties referred to in the previous paragraph.

CHAPTER IX

Violations and penalties

Article 28. Enforcement in this area of the legally established sanctioning regime.

1. The offences committed against the provisions of this Royal Decree shall have the character of administrative infringements of health legislation in accordance with the provisions of Chapter VI of Title I of Law 14/1986 of 25 April 1986, General of Health, and of the other provisions resulting from implementation. The corresponding penalties shall be imposed on the instruction of the relevant file, in accordance with the provisions of Law No 30/1992 of 26 November of the Legal Regime of Public Administrations and of the Administrative Procedure. Common, and in Royal Decree 1398/1993 of 4 August, approving the Rules of Procedure for the exercise of sanctioning powers. This shall be without prejudice to any civil, criminal or other order that may be held.

2. Minor infringements shall be considered:

Failure to comply with the provisions of this Royal Decree, or in the provisions that develop it, insofar as it is not classified as serious or very serious, as required by Article 35-A-3. of the General Law of Health.

3. Serious infringements shall be considered:

(a) Failure to comply with the obligation to provide false or inaccurate information, to the competent authority, to the information required in connection with the notification procedure, as required by Article 35-B-4. the General Health Law.

(b) Non-compliance with the requirements for classification, packaging and labelling of substances, considered as being of course provided for in Article 35-B-1. and 4. of the General Health Law.

(c) The absence of any of the data required in the safety data sheet, as provided for in Article 35-B-1. and 2. of the General Health Law.

d) The recidivism in the commission of minor infractions in the last 3 months, as provided for in article 35-B-7. of the General Law of Health.

4. Serious infringements will be considered:

(a) The placing on the market of a new substance without prior notification of the substance, considered as being the case provided for in Article 35-C-1. and 2. of the General Health Law.

(b) Non-communication to the competent authority of the increase of quantities of marketed substances, other than the initial notification, considered as being of course provided for in Article 35-C-1. and 2. of the Law General of Health.

(c) The placing on the market of dangerous substances without the safety data sheet, considered as supposed to be provided for in Article 35-C-1. and 2. of the General Health Law.

d) The conscious and deliberate non-compliance with the requirements for classification, packaging and labelling of substances, where the same poses a serious risk to public health and the environment, considered as being of course those provided for in Article 35-C-1. and 2. of the General Health Law.

e) The recidivism in the commission of serious misconduct in the last five years, as required by article 35-C-8. of the General Law of Health.

5. The offences described in the preceding paragraphs shall give rise to the imposition of the penalties provided for in Article 36 of Law 14/1986 of 25 April of 25

.

6. For the imposition of the appropriate penalties, consideration shall be given to the extent of the existing dolo or fault, as well as its impact on public health and the environment and its economic significance.

7. In accordance with the provisions of Article 33 of Law 14/1986 of 25 April 1986, General Health, these penalties shall be independent of those which may be imposed by other competent authorities on grounds other than those of infringement of the health rules. To this end, the various authorities shall exchange the background and information in their possession.

To this end, the various authorities will exchange the background and information in their possession.

[SEPARATE SUPPLEMENT IS PUBLISHED]