P7_TA(2013)0008 Classification, packaging and labelling of dangerous preparations ***I European Parliament legislative resolution of 16 January 2013 on the proposal for a directive of the European Parliament and of the Council on the classification, packaging and labelling of dangerous preparations (recast) (COM(2012)0008 — C7-0021/2012 — 2012/0007(COD)) P7_TC1-COD(2012)0007 Position of the European Parliament adopted at first reading on 16 January 2013 with a view to the adoption of Directive 2013/…/EU of the European Parliament and of the Council on the classification, packaging and labelling of dangerous preparations (recast)
Date: 2013-01-16
Institutions: Committee on Legal Affairs, Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: classification, dangerous substance, labelling, marketing standard, packaging








C_2015440EN.01011701.xml










30.12.2015   


EN


Official Journal of the European Union


C 440/117





P7_TA(2013)0008
Classification, packaging and labelling of dangerous preparations ***I
European Parliament legislative resolution of 16 January 2013 on the proposal for a directive of the European Parliament and of the Council on the classification, packaging and labelling of dangerous preparations (recast) (COM(2012)0008 — C7-0021/2012 — 2012/0007(COD))
(Ordinary legislative procedure — recast)
(2015/C 440/23)

The European Parliament,






—


having regard to the Commission proposal to Parliament and the Council (COM(2012)0008),










—


having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7-0021/2012),










—


having regard to Article 294(3) of the Treaty on the Functioning of the European Union,










—


having regard to the opinion of the European Economic and Social Committee of 28 March 2012 (1),










—


having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts (2),










—


having regard to the letter of 9 November 2012 from the Committee on Legal Affairs to the Committee on the Environment, Public Health and Food Safety in accordance with Rule 87(3) of its Rules of Procedure,










—


having regard to Rules 87 and 55 of its Rules of Procedure,










—


having regard to the report of the Committee on the Environment, Public Health and Food Safety (A7-0391/2012),










A.


whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;












1.


Adopts its position at first reading hereinafter set out, taking into account the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission;












2.


Calls on the Commission to refer the matter to Parliament again if it intends to amend the proposal substantially or replace it with another text;












3.


Instructs its President to forward its position to the Council, the Commission and the national parliaments.






(1)  OJ C 181, 21.6.2012, p. 203.

(2)  OJ C 77, 28.3.2002, p. 1.


P7_TC1-COD(2012)0007
Position of the European Parliament adopted at first reading on 16 January 2013 with a view to the adoption of Directive 2013/…/EU of the European Parliament and of the Council on the classification, packaging and labelling of dangerous preparations (recast)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national Parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the ordinary legislative procedure (2),
Whereas:






(1)


Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (3) has been substantially amended several times (4). Since further amendments are to be made, that Directive should be recast in the interests of clarity.










(2)


The approximation of the rules existing in the Member States relating to classification, packaging and labelling of certain dangerous preparations is essential for setting equal competition conditions and the functioning of the internal market.










(3)


Measures for the approximation of the provisions of the Member States affecting the functioning of the internal market should, in so far as they concern health, safety and protection of man and the environment, adopt a high level of protection as a basis. This Directive should, at the same time, ensure protection for the general public, and, in particular, persons who come into contact with dangerous preparations in the course of their work or in the pursuit of a hobby, protection for consumers and for the environment.










(4)


The number of animals used for experiments should be reduced to a minimum, in accordance with the provisions of Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (5). Pursuant to Article 4(1) of that Directive, Member States are to ensure that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, are used instead of a procedure within the meaning of that Directive, defined as any use, invasive or non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. Therefore, this Directive makes use of the results of assessments of toxicological and ecotoxicological properties only when these are already known and entails no obligation to conduct further experiments on animals.










(5)


Although munitions are not covered by this Directive, explosives marketed to produce an explosive or pyrotechnic effect may, through their chemical composition, present dangers to health. It is therefore necessary as part of a transparent information process to classify them in accordance with this Directive and assign to them a safety data sheet in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (6), and also to label them in accordance with the international rules used for the transport of dangerous goods.










(6)


Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (7) and Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (8), in contrast to the provisions applicable to chemical preparations covered by this Directive, provide for an authorisation procedure for each product on the basis of a dossier presented by the applicant and an assessment carried out by the competent authority in each Member State. Furthermore, that authorisation procedure includes a control relating specifically to the classification, packaging and labelling of each product before it is placed on the market. It is appropriate, as part of a clear and transparent information process, to classify and label plant protection products and biocidal products in accordance with this Directive, and also to provide instructions for use in accordance with the results of the evaluation carried out in the framework of Regulation (EC) No 1107/2009 and Directive 98/8/EC and to ensure that the labelling satisfies the high level of protection sought by both this Directive and Regulation (EC) No 1107/2009 or Directive 98/8/EC respectively . In addition, a safety data sheet has to be established for plant protection products and biocidal products in accordance with Regulation (EC) No 1907/2006.










(7)


It is necessary to provide for concentration limits expressed as a volume/volume percentage in the case of preparations marketed in gaseous form.










(8)


It is necessary to define what human experience might be considered for the evaluation of the health hazards of a preparation. If clinical studies may be accepted, it is taken as given that such studies comply with the Helsinki Declaration and the Guidelines for Good Clinical Practice of the Organisation for Economic Co-operation and Development.










(9)


As the existing safety data sheet is already being used as a communication tool within the supply chain of substances and preparations, has been developed further and has been made an integral part of the system established by Regulation (EC) No 1907/2006, it should be removed from this Directive .










(10)


Due to the adoption of Regulation (EC) No 1907/2006, Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (9) has been adapted and its rules on the notification and risk assessment of chemicals have been deleted. This Directive should be adapted accordingly.










(11)


Annex V to Directive 67/548/EEC, setting out methods for the determination of the physico-chemical properties, toxicity and ecotoxicity of substances and preparations, has been deleted by Directive 2006/121/EC of the European Parliament and of the Council (10) with effect from 1 June 2008. The references to that Annex in this Directive should be adapted accordingly.










(12)


In order to take full account of the work and experience accumulated under Directive 67/548/EEC, including the classification and labelling of specific substances listed in Annex I to that Directive, all existing harmonised classifications should be converted into new harmonised classifications using the new criteria. Moreover, as the applicability of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (11) is deferred and the harmonised classifications in accordance with the criteria of Directive 67/548/EEC are relevant for the classification of substances and mixtures during the ensuing transition period, all existing harmonised classifications should also be placed unchanged in an annex to that Regulation. By subjecting all future harmonisations of classifications to that Regulation, inconsistencies in harmonised classifications of the same substance under the existing and the new criteria should be avoided.










(13)


Preparations composed of more than one substance being classified in Table 3.2 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogenic, mutagenic and/or toxic for reproduction had to be labelled with risk phrases (R phrases) to indicate both category 1 or 2 and category 3 classification. However, providing both R phrases sends a conflicting message. Preparations should therefore only be classified and labelled with the higher category.










(14)


The references to R phrase R40 in Directive 67/548/EEC were amended by Commission Directive 2001/59/EC (12) when R phrase R40 was assigned to carcinogens of category 3. Consequently, the old wording of R phrase R40 became R68 and was used for mutagens of category 3 and for certain substances with non-lethal irreversible effects. The references to R phrase R40 in this Directive should be adapted accordingly.










(15)


Annex VI to Directive 67/548/EEC as amended by Directive 2001/59/EC gives clear advice on the classification of substances and preparations for corrosive effects. In this Directive, preparations should therefore be classified accordingly.










(16)


It is known that cement preparations containing chromium (VI) may cause allergic reactions in certain circumstances. Such preparations should display the relevant warning label.










(17)


Directive 67/548/EEC as amended by Commission Directive 98/98/EC (13) provides for new criteria and a new R phrase (R67) for vapours which may cause drowsiness and dizziness. Preparations should be classified and labelled accordingly.










(18)


Criteria developed for classifying and labelling substances dangerous for the environment were introduced together with the appropriate symbols, indications of danger, risk phrases and safety advice required to appear on labelling, by Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC (14) and by Commission Directive 93/21/EEC of 27 April 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC (15). Provisions are required at Union level on the classification and labelling of preparations to take account of their effects on the environment, and it is therefore necessary to provide for a method for assessing the hazards of a given preparation for the environment either by a calculation method, or by determining the ecotoxicological properties by test methods under certain conditions.










(19)


For substances very toxic to the aquatic environment (classified as N) and assigned the R phrases R50 or R50/53, specific concentration limits (SCLs) are applied to substances listed in Table 3.2 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 in order to avoid an underestimation of the hazard. This measure creates distortions between preparations containing substances listed in that Annex, to which SCLs are applied, and those preparations containing substances not yet included in that Annex, but classified and labelled provisionally in accordance with Article 6 of Directive 67/548/EEC and to which no SCLs are applicable. It is therefore necessary to ensure that SCLs are applied in the same way to all preparations containing substances very toxic to the aquatic environment.










(20)


Directive 2001/59/EC revised the criteria in Annex VI to Directive 67/548/EEC for the classification and labelling of ozone depleting substances. The revised Annex III now only provides for the assignment of the symbol N in addition to R phrase R59. Preparations should be classified and labelled accordingly.










(21)


The confidentiality of certain substances contained in the preparations should be guaranteed, and it is therefore necessary to institute a system which allows the person responsible for placing the preparation on the market to request confidentiality for such substances.










(22)


The label constitutes a basic tool for users of the dangerous preparations in so far as it provides them with the initial essential concise information. It nevertheless needs to be supplemented by a two-fold system of more detailed information, consisting firstly of the safety data sheet intended for professional users as provided for in Regulation (EC) No 1907/2006 and secondly of the bodies appointed by the Member States which are responsible for the provision of information solely for medical purposes, both preventive and curative.










(23)


Containers containing certain categories of dangerous preparations offered or sold to the general public must be fitted with child-resistant fastenings and/or carry a tactile warning of danger. Certain preparations not falling within these categories of danger may nevertheless, owing to their composition, present a danger for children. The packaging of such preparations should therefore be equipped with child-resistant fastenings.










(24)


In order to take account of certain preparations which, although they are not considered dangerous under this Directive, may nevertheless present a danger for users, it is necessary that certain provisions of this Directive cover such preparations.










(25)


This Directive contains special labelling provisions applicable to certain preparations. To ensure an adequate level of protection for man and the environment, special labelling provisions should also be laid down for certain preparations which, although not dangerous within the meaning of this Directive, may nevertheless present a danger to the user.










(26)


In the case of preparations classified as dangerous within the meaning of this Directive, it is appropriate to permit Member States to allow certain derogations with respect to labelling where the packaging is too small, or otherwise unsuitable for labelling, or where such small packaging or such small quantities are involved that there is no reason to fear any danger to man or the environment. In such cases appropriate consideration should also be given to the approximation of the relevant provisions at Union level.










(27)


It is appropriate to provide, in relation to environmental labelling, that specific exemptions or specific provisions may be decided upon in specific cases where it can be demonstrated that the overall environmental impact of the product types in question is lower than that of corresponding product types.










(28)


In order to supplement or amend certain non-essential elements of this Directive, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of determining exemptions to certain provisions on environmental labelling, deciding on measures in the framework of the special provisions on the labelling of certain preparations and adapting the Annexes to technical progress. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.










(29)


In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (16).










(30)


This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex VIII, Part B,




HAVE ADOPTED THIS DIRECTIVE:

Article 1

Objectives and scope
1.   This Directive aims at the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, and to the approximation of specific provisions for certain preparations which may present hazards, whether or not they are classified as dangerous within the meaning of this Directive, when such preparations are placed on the market of the Member States.
2.   This Directive shall apply to preparations which:






(a)


contain at least one dangerous substance within the meaning of Article 2; and










(b)


are considered dangerous within the meaning of Article 5, 6 or 7.




3.   The specific provisions set out in Article 9 and Annex IV, and those set out in Article 10 and Annex V shall also apply to preparations which are not considered dangerous within the meaning of Article 5, 6 or 7 but which may nevertheless present a specific hazard.
4.   Without prejudice to Regulation (EC) No 1107/2009, the articles on classification, packaging and labelling of this Directive shall apply to plant protection products.
5.   This Directive shall not apply to the following preparations in the finished state, intended for the final user:






(a)


veterinary medicinal products and medicinal products for human use, as defined in Directives 2001/82/EC (17) and 2001/83/EC (18) of the European Parliament and of the Council respectively;










(b)


cosmetic products as defined in Council Directive 76/768/EEC (19);










(c)


mixtures of substances which, in the form of waste, are covered by Directive 2008/98/EC of the European Parliament and of the Council (20);










(d)


foodstuffs;










(e)


animal feedingstuffs;










(f)


preparations containing radioactive substances as defined by Council Directive 96/29/Euratom (21);










(g)


medical devices which are invasive or used in direct physical contact with the human body in so far as Union measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as this Directive.




6.   This Directive shall not apply to:






(a)


the carriage of dangerous preparations by rail, road, inland waterway, sea or air;










(b)


preparations in transit which are under customs supervision, provided they do not undergo any treatment or processing.





Article 2

Definitions
1.   For the purposes of this Directive, the following definitions shall apply:






(a)


‘substances’ means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;










(b)


‘preparations’ means mixtures or solutions composed of two or more substances;










(c)


‘polymer’ means a substance consisting of molecules characterised by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. In the context of this definition a ‘monomer unit’ means the reacted form of a monomer in a polymer;










(d)


‘placing on the market’ means making available to third parties. Importation into the customs territory of the Union shall be deemed to be placing on the market for the purposes of this Directive;










(e)


‘scientific research and development’ means scientific experimentation, analysis or chemical research carried out under controlled conditions; it includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development;










(f)


‘process-orientated research and development’ means the further development of a substance in the course of which pilot plant or production trials are used to test the fields of application of the substance;










(g)


‘Einecs’ means the European Inventory of Existing Commercial Chemical Substances. This inventory contains the definitive list of all chemical substances deemed to be on the Union market on 18 September 1981.




2.   The following are ‘dangerous’ within the meaning of this Directive:






(a)


explosive substances and preparations: solid, liquid, pasty or gelatinous substances and preparations which may also react exothermically without atmospheric oxygen thereby quickly evolving gases, and which, under defined test conditions, detonate, quickly deflagrate or upon heating explode when partially confined;










(b)


oxidising substances and preparations: substances and preparations which give rise to a highly exothermic reaction in contact with other substances, particularly flammable substances;










(c)


extremely flammable substances and preparations: liquid substances and preparations having an extremely low flash-point and a low boiling-point and gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure;










(d)


highly flammable substances and preparations:






(i)


substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any application of energy; or










(ii)


solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition; or










(iii)


liquid substances and preparations having a very low flash-point; or










(iv)


substances and preparations which, in contact with water or damp air, evolve extremely flammable gases in dangerous quantities;














(e)


flammable substances and preparations: liquid substances and preparations having a low flash-point;










(f)


very toxic substances and preparations: substances and preparations which in very low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;










(g)


toxic substances and preparations: substances and preparations which in low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;










(h)


harmful substances and preparations: substances and preparations which may cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;










(i)


corrosive substances and preparations: substances and preparations which may, on contact with living tissues, destroy them;










(j)


irritant substances and preparations: non-corrosive substances and preparations which, through immediate, prolonged or repeated contact with the skin or mucous membrane, may cause inflammation;










(k)


sensitising substances and preparations: substances and preparations which, if they are inhaled or if they penetrate the skin, are capable of eliciting a reaction of hypersensitisation such that on further exposure to the substance or preparation, characteristic adverse effects are produced;










(l)


carcinogenic substances and preparations: substances or preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence;










(m)


mutagenic substances and preparations: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce heritable genetic defects or increase their incidence;










(n)


substances and preparations which are toxic for reproduction: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may produce, or increase the incidence of, non-heritable adverse effects in the progeny and/or an impairment of male or female reproductive functions or capacity;










(o)


substances and preparations which are dangerous for the environment: substances and preparations which, were they to enter the environment, would or could present an immediate or delayed danger for one or more components of the environment.





Article 3

Determination of dangerous properties of preparations
1.   The evaluation of the hazards of a preparation shall be based on the determination of:






(a)


physico-chemical properties;










(b)


properties affecting health;










(c)


environmental properties.




Those different properties shall be determined in accordance with Articles 5, 6 and 7.
Where laboratory tests are conducted, they shall be carried out on the preparation as placed on the market.
2.   Where the determination of dangerous properties is carried out in accordance with Articles 5, 6 and 7, all dangerous substances within the meaning of Article 2 and in particular the following shall be taken into consideration in accordance with the provisions laid down in the method used:






(a)


substances listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008;










(b)


substances classified and labelled provisionally by the person responsible for the placing on the market in accordance with Article 6 of Directive 67/548/EEC.




3.   For preparations covered by this Directive, dangerous substances as referred to in paragraph 2 which are classified as dangerous on the basis of their health and/or environmental effects, whether they are present as impurities or additives, shall be taken into consideration when their concentrations are equal to, or greater than, those defined in the following table unless lower values are given in Part 3 of Annex VI to Regulation (EC) No 1272/2008 , or in Part B of Annex II to this Directive or in Part B of Annex III thereto, unless otherwise specified in Annex V to this Directive.







Category of danger of the substance


Concentration to take into consideration for




gaseous preparations
% vol/vol


other preparations
% w/w




Very toxic


≥ 0,02


≥ 0,1




Toxic


≥ 0,02


≥ 0,1




Carcinogenic
Category 1 or 2


≥ 0,02


≥ 0,1




Mutagenic
Category 1 or 2


≥ 0,02


≥ 0,1




Toxic for reproduction
Category 1 or 2


≥ 0,02


≥ 0,1




Harmful


≥ 0,2


≥ 1




Corrosive


≥ 0,02


≥ 1




Irritant


≥ 0,2


≥ 1




Sensitising


≥ 0,2


≥ 1




Carcinogenic
Category 3


≥ 0,2


≥ 1




Mutagenic
Category 3


≥ 0,2


≥ 1




Toxic for reproduction
Category 3


≥ 0,2


≥ 1




Dangerous for the environment N


 


≥ 0,1




Dangerous for the environment ozone


≥ 0,1


≥ 0,1




Dangerous for the environment


 


≥ 1





Article 4

General principles of classification and labelling
1.   The classification of dangerous preparations according to the degree and specific nature of the hazards involved shall be based on the definitions of categories of danger laid down in Article 2.
2.   The general principles of the classification and labelling of preparations shall be applied in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC, save where alternative criteria referred to in Article 5, 6, 7 or 10 and the relevant Annexes of this Directive are applied.

Article 5

Evaluation of the hazards deriving from physico-chemical properties
1.   The hazards of a preparation deriving from its physico-chemical properties shall be assessed by determining, by means of the methods specified in Part A of the Annex to Council Regulation (EC) No 440/2008 (22), the physico-chemical properties of the preparation necessary for appropriate classification and labelling in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.
2.   By way of derogation from paragraph 1, the determination of the explosive, oxidising, extremely flammable, highly flammable, or flammable properties is not necessary provided that:






(a)


none of the constituents possesses such properties and that, on the basis of the information available to the manufacturer, the preparation is unlikely to present hazards of this kind;










(b)


in the event of a change in the composition of a preparation of known composition, scientific evidence indicates that a reassessment of the hazards will not lead to a change in classification;










(c)


preparations placed on the market in the form of aerosols satisfy the provisions of Article 8(1a) of Council Directive 75/324/EEC (23).




3.   For certain cases for which the methods laid down in Part A of the Annex to Regulation (EC) No 440/2008 are not appropriate, alternative calculation methods are laid down in Part B of Annex I to this Directive.
4.   Certain exemptions from the application of the methods laid down in Part A of the Annex to Regulation (EC) No 440/2008 are referred to in Part A of Annex I to this Directive.
5.   The hazards deriving from the physico-chemical properties of a preparation covered by Regulation (EC) No 1107/2009 shall be assessed by determining the physico-chemical properties of the preparation necessary for appropriate classification in accordance with the criteria set out in Annex VI to Directive 67/548/EEC. Those properties shall be determined by means of the methods laid down in Part A of the Annex to Regulation (EC) No 440/2008 unless other internationally recognised methods are acceptable in accordance with the provisions of Commission Regulations (EU) No 544/2011 (24) and (EU) No 545/2011 (25).

Article 6


Evaluation of health hazards

1.   The health hazards of a preparation shall be assessed by one or more of the following procedures:






(a)


by a conventional method described in Annex II;










(b)


by determining the toxicological properties of the preparation necessary for appropriate classification in accordance with the criteria in Annex VI to Directive 67/548/EEC. Those properties shall be determined by means of the methods laid down in Part B of the Annex to Regulation (EC) No 440/2008, unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Regulations (EU) No 544/2011 and (EU) No 545/2011.




2.   Without prejudice to the requirements of Regulation (EC) No 1107/2009 , only where it can be scientifically demonstrated by the person responsible for placing the preparation on the market that the toxicological properties of the preparation cannot correctly be determined by the method outlined in point (a) of paragraph 1, or on the basis of existing test results on animals, the methods outlined in point (b) of paragraph 1 may be used, provided they are justified or specifically authorised under Article 12 of Directive 86/609/EEC.
When a toxicological property is established by the methods outlined in point (b) of paragraph 1 to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC of the European Parliament and the Council (26) and the provisions of Directive 86/609/EEC, in particular Articles 7 and 12 thereof.
Subject to the provisions of paragraph 3, where a toxicological property has been established on the basis of both the methods outlined in points (a) and (b) of paragraph 1, the results from the methods outlined in point (b) of paragraph 1 shall be used for classifying the preparation, except in the case of carcinogenic, mutagenic or toxic effects for reproduction for which only the method outlined in point (a) of paragraph 1 shall be used.
Any of the toxicological properties of the preparation which are not assessed by the method outlined in point (b) of paragraph 1 shall be assessed in accordance with the method outlined in point (a) of paragraph 1.
3.   Furthermore, where it can be demonstrated by epidemiological studies, by scientifically valid case studies as specified by Annex VI to Directive 67/548/EEC or by statistically backed experience, such as the assessment of data from poison information units or concerning occupational diseases:






—


that toxicological effects on man differ from those suggested by the application of the methods outlined in paragraph 1, then the preparation shall be classified according to its effects on man,










—


that, owing to effects such as potentiation, a conventional assessment would underestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation,










—


that, owing to effects such as antagonism, a conventional assessment would overestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation.




4.   For preparations of a known composition, with the exception of those covered by Regulation (EC) No 1107/2009 , classified in accordance with point (b) of paragraph 1, a new evaluation of health hazard by the methods outlined in either point (a) or point (b) of paragraph 1 shall be performed whenever:






—


changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer, in accordance with the following table:






Initial concentration range of the constituent


Permitted variation in initial concentration of the constituent




≤ 2,5 %


± 30 %




> 2,5 ≤ 10 %


± 20 %




> 10 ≤ 25 %


± 10 %




> 25 ≤ 100 %


± 5 %














—


changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions set out in Article 2, are introduced by the manufacturer.




This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Article 7

Evaluation of environmental hazards
1.   The hazards of a preparation for the environment shall be assessed by one or more of the following procedures:






(a)


by a conventional method described in Annex III;










(b)


by determining the hazardous properties of the preparation for the environment necessary for appropriate classification in accordance with the criteria set out in Annex VI to Directive 67/548/EEC. Those properties shall be determined by means of the methods laid down in Part C of the Annex to Regulation (EC) No 440/2008 unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Regulations (EU) No 544/2011 and (EU) No 545/2011. Without prejudice to the testing requirements laid down in or pursuant to Regulation (EC) No 1107/2009 , the conditions for application of the test methods are described in Part C of Annex III to this Directive.




2.   Where an ecotoxicological property is established by one of the methods outlined in point (b) of paragraph 1 to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC and with the provisions of Directive 86/609/EEC.
Where the environmental hazards have been assessed in compliance with both of the procedures mentioned above, the results of the methods referred to in point (b) of paragraph 1 shall be used for classifying the preparation.
3.   For preparations of a known composition, with the exception of those covered by Regulation (EC) No 1107/2009, classified in accordance with the method outlined in point (b) of paragraph 1, a new evaluation of environmental hazard either by the method outlined in point (a) of paragraph 1 or that outlined in point (b) of paragraph 1 shall be performed whenever:






—


changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer, in accordance with the following table:






Initial concentration range of the constituent


Permitted variation in initial concentration of the constituent




≤ 2,5 %


± 30 %




> 2,5 ≤ 10 %


± 20 %




> 10 ≤ 25 %


± 10 %




> 25 ≤ 100 %


± 5 %














—


changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions set out in Article 2, are introduced by the manufacturer.




This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Article 8

Obligations and duties of the Member States
1.   Member States shall take all necessary measures to ensure that the preparations covered by this Directive cannot be placed on the market unless they comply with it.
2.   In order to ensure compliance with this Directive, the authorities of the Member States may request information on the composition of the preparation and any other pertinent information from any person responsible for placing the preparation on the market.
3.   Member States shall take all necessary measures to ensure that those responsible for placing the preparation on the market keep at the disposal of the authorities of the Member States:






(a)


the data used for the classification and labelling of the preparation;










(b)


any pertinent information relating to packaging requirements in accordance with point (c) of Article 9, including the test certificate issued in accordance with Part A of Annex IX to Directive 67/548/EEC;










(c)


the data used for establishing the safety data sheet, in accordance with Article 31 of Regulation (EC) No 1907/2006.




4.   Member States and the Commission shall exchange information concerning the name and full address of the national authority or authorities responsible for communicating and exchanging information relating to the practical application of this Directive.

Article 9

Packaging
1.   Member States shall take all necessary measures to ensure that:






(a)


preparations within the meaning of Article 1(2) and preparations covered by Annex IV pursuant to Article 1(3) cannot be placed on the market unless their packaging satisfies the following requirements:






(i)


it shall be so designed and constructed that its contents cannot escape; this requirement shall not apply where special safety devices are prescribed;










(ii)


the materials constituting the packaging and fastenings must not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents;










(iii)


packaging and fastenings must be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;










(iv)


containers fitted with replaceable fastening devices shall be so designed that the packaging can be refastened repeatedly without the contents escaping;














(b)


containers which contain preparations within the meaning of Article 1(2) and preparations covered by Annex IV pursuant to Article 1(3) offered or sold to the general public do not have:






(i)


either a shape and/or graphic decoration likely to attract or arouse the active curiosity of children or to mislead consumers; or










(ii)


a presentation and/or a designation used for foodstuffs or animal feeding stuffs or medicinal or cosmetic products;














(c)


containers which contain certain preparations offered or sold to the general public covered by Annex IV:






(i)


are fitted with child-resistant fastenings; and/or










(ii)


carry a tactile warning of danger.








The devices must conform to the technical specifications given in Parts A and B of Annex IX to Directive 67/548/EEC.
2.   The packaging of preparations shall be deemed to satisfy the requirements of points (a)(i), (ii) and (iii) of paragraph 1 if it complies with the requirements for carriage of dangerous goods by rail, road, inland waterway, sea or air.

Article 10

Labelling
1.   Member States shall take all necessary measures to ensure that:






(a)


preparations within the meaning of Article 1(2) cannot be placed on the market unless the labelling on their packaging satisfies all the requirements of this Article and the specific provisions of Parts A and B of Annex V;










(b)


preparations within the meaning of Article 1(3) as defined in Parts B and C of Annex V cannot be placed on the market unless the labelling on their packaging satisfies the requirements of points (a) and (b) of paragraph 3 of this Article and the specific provisions of Parts B and C of Annex V.




2.   With respect to plant protection products subject to Regulation (EC) No 1107/2009, the labelling requirements in accordance with this Directive shall be accompanied by the following wording:

‘To avoid risks to man and the environment, comply with the instructions for use.’

This labelling shall be without prejudice to the information required in accordance with Article 65 of Regulation (EC) No 1107/2009 and Annexes I and III to Commission Regulation (EU) No 547/2011 (27) .
3.   The following information shall be clearly and indelibly marked on any package:






(a)


the trade name or designation of the preparation;










(b)


the name, full address and telephone number of the person established in the Union who is responsible for placing the preparation on the market, whether it be the manufacturer, the importer or the distributor;










(c)


the chemical name of the substance or substances present in the preparation in accordance with the following detailed rules:






(i)


for preparations classified T+, T, Xn in accordance with Article 6, only the substances T+, T, Xn present in concentrations equal to, or greater than, the lowest limit (limit Xn) for each of them laid down in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or, failing that, Part B of Annex II to this Directive have to be taken into consideration;










(ii)


for preparations classified C in accordance with Article 6, only C substances present in concentrations equal to, or greater than, the lowest limit (limit Xi) laid down in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or, failing that, Part B of Annex II to this Directive have to be taken into consideration;










(iii)


the name of the substances which have given rise to the classification of the preparation in one or more of the following danger categories shall be mentioned on the label:






—


carcinogen category 1, 2 or 3,










—


mutagen category 1, 2 or 3,










—


toxic for reproduction category 1, 2 or 3,










—


very toxic, toxic or harmful due to non-lethal effects after a single exposure,










—


toxic or harmful due to severe effects after repeated or prolonged exposure,










—


sensitising.




The chemical name shall be one of the designations listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or an internationally recognised chemical nomenclature if no corresponding designation is yet listed in that Annex;










(iv)


the name of any substance which led to the classification of the preparation in the following danger categories need not be mentioned on the label, unless the substance has to be mentioned pursuant to points (i), (ii) or (iii):






—


explosive,










—


oxidising,










—


extremely flammable,










—


highly flammable,










—


flammable,










—


irritant,










—


dangerous for the environment;














(v)


as a general rule, a maximum of four chemical names shall suffice to identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding phrases referring to the risk involved. In some cases, more than four chemical names may be necessary;














(d)


the danger symbol(s) and indication(s) of danger. The danger symbols, where specified in this Directive, and indications of the dangers involved in the use of the preparation, shall be in accordance with Annexes II and VI to Directive 67/548/EEC and shall be applied in accordance with the evaluation of the hazards carried out in accordance with Annexes I, II and III to this Directive.
Where more than one danger symbol must be assigned to a preparation the obligation to apply the symbol:






(i)


T shall make the symbols C and X optional unless otherwise specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008;










(ii)


C shall make the symbol X optional;










(iii)


E shall make the symbols F and O optional;










(iv)


Xn shall make the symbol Xi optional.




The symbol(s) shall be printed in black on an orange-yellow background;










(e)


the risk phrases (R phrases). The indications concerning special risks (R phrases) shall comply with Annexes III and VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Annexes I, II, and III to this Directive.
As a general rule, a maximum of six R phrases shall suffice to describe the risks; for this purpose, the combined phrases listed in Annex III to Directive 67/548/EEC shall be regarded as single phrases. However, if the preparation falls within more than one danger category, those standard phrases shall cover all the principal hazards associated with the preparation. In some cases more than six R phrases may be necessary.
The standard phrases ‘extremely flammable’ or ‘highly flammable’ need not be used where they describe an indication of danger used in accordance with point (d) of this paragraph;










(f)


the safety advice (S phrases). The indications giving safety advice (S phrases) shall comply with Annex IV and with Annex VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Annexes I, II and III to this Directive.
As a general rule, a maximum of six S phrases shall suffice to formulate the most appropriate safety advice; for this purpose the combined phrases listed in Annex IV to Directive 67/548/EEC shall be regarded as single phrases. However, in some cases more than six S phrases may be necessary.
Where it is physically impossible to include the advice on the label or package itself, the package shall be accompanied by safety advice on the use of the preparation;










(g)


the nominal quantity (nominal mass or nominal volume) of the contents in the case of preparations offered or sold to the general public.




4.   In relation to certain preparations classified as dangerous within the meaning of Article 7, by way of derogation from points (d), (e) and (f) of paragraph 3 of this Article, the Commission shall be empowered to adopt delegated acts in accordance with Article 20 for the purpose of determining exemptions to certain provisions on environmental labelling or specific provisions in relation to environmental labelling, where it can be demonstrated that there would be a reduction in the environmental impact. Those exemptions or specific provisions are defined and laid down in Part A or B of Annex V.
5.   If the contents of the package do not exceed 125 ml:






(a)


in the case of preparations that are classified as highly flammable, oxidising, irritant, with the exception of those assigned R41, or dangerous for the environment and assigned the N symbol it shall not be necessary to indicate the R phrases or the S phrases;










(b)


in the case of preparations that are classified as flammable or dangerous for the environment and not assigned the N symbol it shall be necessary to indicate the R phrases but it shall not be necessary to indicate the S phrases.




6.   Without prejudice to point 3 of Annex I to Regulation (EU) No 547/2011 , indications such as ‘non-toxic’, ‘non-harmful’, ‘non-polluting’, ‘ecological’ or any other statement indicating that the preparation is not dangerous or likely to lead to underestimation of the dangers of the preparation in question shall not appear on the packaging or labelling of any preparation subject to this Directive.

Article 11

Implementation of the labelling requirements
1.   Where the particulars required by Article 10 appear on a label, that label shall be firmly affixed to one or more surfaces of the packaging so that those particulars can be read horizontally when the package is set down normally. The dimensions of the label are laid down in Annex VI to Directive 67/548/EEC and the label is intended solely for provision of the information required by this Directive and if necessary of any supplementary health or safety information.
2.   A label shall not be required when the particulars are clearly shown on the package itself, as specified in paragraph 1.
3.   The colour and presentation of the label — or, in the case of paragraph 2, of the package — shall be such that the danger symbol and its background stand out clearly from it.
4.   The information required on the label under Article 10 shall stand out clearly from its background and shall be of such size and spacing as to be easily read.
Specific provisions regarding the presentation and format of this information shall be laid down in Annex VI to Directive 67/548/EEC.
5.   Member States may make the placing on the market of preparations covered by this Directive within their territories subject to the use of their official language or languages in respect of the labelling thereof.
6.   For the purposes of this Directive, labelling requirements shall be deemed to be satisfied:






(a)


in the case of an outer package containing one or more inner packages, if the outer package is labelled in accordance with international rules on the transport of dangerous goods and the inner package or packages are labelled in accordance with this Directive;










(b)


in the case of a single package:






(i)


if such a package is labelled in accordance with international rules on the transport of dangerous goods and with points (a), (b), (c), (e) and (f) of Article 10(3); for preparations classified in accordance with Article 7, the provisions of Article 10(3)(d) shall additionally apply with respect to the property in question when it has not been so identified on the label; or










(ii)


where appropriate, for particular types of packaging such as mobile gas cylinders, if the specific requirements referred to in Annex VI to Directive 67/548/EEC are complied with.




Where dangerous preparations do not leave the territory of a Member State, labelling may be permitted which complies with national rules instead of with international rules on the transport of dangerous goods.





Article 12

Exemptions from the labelling and packaging requirements
1.   Articles 9, 10 and 11 shall not apply to explosives placed on the market with a view to obtaining an explosive or pyrotechnic effect.
2.   For certain dangerous preparations within the meaning of Article 5, 6 or 7 defined in Annex VII which, in the form in which they are placed on the market, do not present any physico-chemical risk, or risk to health or to the environment, Articles 9, 10 and 11 shall not apply.
3.   Member States may also:






(a)


permit the labelling required by Article 10 to be applied in some other appropriate manner on packages which are either too small or otherwise unsuitable for labelling in accordance with Article 11(1) and (2);










(b)


by way of derogation from Articles 10 and 11 permit the packaging of dangerous preparations which are classified as harmful, extremely flammable, highly flammable, flammable, irritant or oxidising to be unlabelled or to be labelled in some other way, if they contain such small quantities that there is no reason to fear any danger to persons handling such preparations or to other persons;










(c)


by way of derogation from Articles 10 and 11, for preparations classified in accordance with Article 7, permit the packaging of dangerous preparations to be unlabelled or labelled in some other way if they contain such small quantities that there is no reason to fear any dangers to the environment;










(d)


by way of derogation from Articles 10 and 11 permit the packaging of dangerous preparations which are not mentioned in points (b) or (c) to be labelled in some other appropriate way, if the packages are too small for the labelling provided for in Articles 10 and 11 and there is no reason to fear any danger to persons handling such preparations or to other persons.




Where this paragraph is applied, the use of symbols, indications of danger, risk (R) phrases or safety (S) phrases different to those laid down in this Directive shall not be permitted.
4.   If a Member State makes use of the options provided for in paragraph 3, it shall forthwith inform the Commission and Member States thereof. 1 The Commission shall be empowered to adopt delegated acts in accordance with Article 20 for the purpose of amending Annex V on the basis of such information .

Article 13

Distance selling
Any advertisement for a preparation within the meaning of this Directive which enables a member of the general public to conclude a contract for purchase without first having sight of the label for that preparation shall make mention of the type or types of hazard indicated on the label. This requirement is without prejudice to Directive 97/7/EC of the European Parliament and of the Council (28).

Article 14

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






—


irritant with the exception of those assigned R41 or irritant in combination with one or more of the other properties mentioned in point (c)(iv) of Article 10(3), or










—


harmful or harmful in combination with one or more of the properties mentioned in point (c)(iv) of Article 10(3) presenting acute lethal effects alone




will put at risk the confidential nature of his intellectual property, he may, in accordance with the provisions of Annex VI, be permitted to refer to that substance either by means of a name that identifies the most important functional chemical groups or by means of an alternative name. This procedure may not be applied where the substance concerned has been assigned a Union exposure limit.
Where the person responsible for placing a preparation on the market wishes to take advantage of confidentiality provisions, he shall make a request to the competent authority of the Member State in which the preparation is to be first placed on the market.
This request shall be made in accordance with the provisions of Annex VI and shall provide the information required in the form in Part A of that Annex. The competent authority may nevertheless request further information from the person responsible for placing the preparation on the market if such information appears necessary in order to evaluate the validity of the request.
The authority of the Member State receiving a request for confidentiality shall notify the applicant of its decision. The person responsible for placing the preparation on the market shall forward a copy of this decision to each of the Member States where he wishes to market the product.
Confidential information brought to the attention of the authorities of a Member State or of the Commission shall be kept secret.
In all cases such information:






—


may be brought to the attention only of the competent authority or authorities responsible for receiving the information necessary for evaluating the foreseeable risks which the preparations may entail for man and the environment, and examining its conformity with the requirements of this Directive,










—


may, however, be divulged to persons directly involved in administrative or legal proceedings involving sanctions which are undertaken for the purpose of controlling substances placed on the market and to persons who are to participate or be heard in legislative proceedings.





Article 15

Rights of Member States regarding safety of workers
This Directive shall not affect the right of Member States to specify, in compliance with the Treaty, the requirements they deem necessary to ensure that workers are protected when using the dangerous preparations in question, provided that this does not mean that the classification, packaging, and labelling of dangerous preparations are modified in a way not provided for in this Directive.

Article 16

Bodies responsible for receiving information relating to health
Member States shall appoint the body or bodies responsible for receiving information, including chemical composition, relating to preparations placed on the market and considered dangerous on the basis of their health effects or on the basis of their physico-chemical effects.
Member States shall take the necessary steps to ensure that the appointed bodies provide all the requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used to meet any medical demand by formulating preventive and curative measures, in particular in case of emergency.
Member States shall ensure that the information is not used for other purposes.
Member States shall ensure that the appointed bodies have at their disposal all the information required from the manufacturers or persons responsible for marketing to carry out the tasks for which they are responsible.

Article 17

Free movement clause
Without prejudice to the provisions set out in other Union legislation, Member States may not prohibit, restrict or impede the placing on the market of preparations because of their classification, packaging and labelling if such preparations comply with the provisions laid down in this Directive.

Article 18

Safeguard clause
1.   Where a Member State has detailed evidence that a preparation, although satisfying the provisions of this Directive, constitutes a hazard for man or the environment on grounds relating to the provisions of this Directive, it may provisionally prohibit the placing on the market of that preparation or subject it to special conditions in its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision.
2.   In the case referred to in paragraph 1, the Commission shall consult the Member States as soon as possible.
3.   The Commission shall decide by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21(2).

Article 19

Adaptation to technical progress
The Commission shall adopt delegated acts in accordance with Article 20 for the purpose of adapting Annexes I to VII to technical progress.

Article 20

Exercise of the delegation
1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2.   The power to adopt delegated acts referred to in Article 10(4), Article 12(4) and Article 19 shall be conferred on the Commission for an indeterminate period of time from … (29)

3.   The delegation of powers referred to in Article 10(4), Article 12(4) and Article 19 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
5.   A delegated act adopted pursuant to Article 10(4), Article 12(4) and Article 19 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by one month

two months
 at the initiative of the European Parliament or of the Council. [Am. 1]


Article 21

Committee procedure
1.   The Commission shall be assisted by the committee established by Article 29(1) of Directive 67/548/EEC. That Committee shall be a Committee within the meaning of Regulation (EU) No 182/2011.
2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 22

Repeal
Directive 1999/45/EC, as amended by the Acts listed in Part A of Annex VIII, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex VIII to the repealed Directive and in Part B of Annex VIII to this Directive.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IX.

Article 23

Entry into force
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 24

Addressees
This Directive is addressed to the Member States.

Done at ,


For the European Parliament


The President




For the Council


The President





(1)  OJ C 181, 21.6.2012, p. 203.

(2)  Position of the European Parliament of 16 January 2013.

(3)  OJ L 200, 30.7.1999, p. 1.

(4)  See Annex VIII, Part A.

(5)  OJ L 276, 20.10.2010, p. 33.

(6)  OJ L 396, 30.12.2006, p. 1.

(7)  OJ L 309, 24.11.2009, p. 1.

(8)  OJ L 123, 24.4.1998, p. 1.

(9)  OJ 196, 16.8.1967, p. 1.

(10)  OJ L 396, 30.12.2006, p. 850.

(11)  OJ L 353, 31.12.2008, p. 1.

(12)  OJ L 225, 21.8.2001, p. 1.

(13)  OJ L 355, 30.12.1998, p. 1.

(14)  OJ L 154, 5.6.1992, p. 1.

(15)  OJ L 110, 4.5.1993, p. 20.

(16)  OJ L 55, 28.2.2011, p. 13.

(17)  OJ L 311, 28.11.2001, p. 1.

(18)  OJ L 311, 28.11.2001, p. 67.

(19)  OJ L 262, 27.9.1976, p. 169.

(20)  OJ L 312, 22.11.2008, p. 3.

(21)  OJ L 159, 29.6.1996, p. 1.

(22)  OJ L 142, 31.5.2008, p. 1.

(23)  OJ L 147, 9.6.1975, p. 40.

(24)  OJ L 155, 11.6.2011, p. 1.

(25)  OJ L 155, 11.6.2011, p. 67.

(26)  OJ L 50, 20.2.2004, p. 44.

(27)  OJ L 155, 11.6.2011, p. 176.

(28)  OJ L 144, 4.6.1997, p. 19.

(29)  Date of entry into force of this Directive.



ANNEX I



METHODS FOR THE EVALUATION OF PHYSICO-CHEMICAL PROPERTIES OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 5


PART A


Exemptions to test methods of Part A of the Annex to Regulation (EC) No 440/2008

See point 2.2.5 of Annex VI to Directive 67/548/EEC.

PART B


Alternative calculation methods


B.1.   Non-gaseous preparations









1.


Method for the determination of oxidising properties of preparations containing organic peroxides.
See point 2.2.2.1 of Annex VI to Directive 67/548/EEC.





B.2.   Gaseous preparations









1.


Method for the determination of oxidising properties
See point 9.1.1.2 of Annex VI to Directive 67/548/EEC.












2.


Method for the determination of flammability properties
See point 9.1.1.1 of Annex VI to Directive 67/548/EEC.








ANNEX II



METHODS FOR THE EVALUATION OF HEALTH HAZARDS OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 6


Introduction

An assessment must be made for all the health effects corresponding to the health effects of substances contained in a preparation. This conventional method described in Parts A and B of this Annex is a calculation method which is applicable to all preparations and which takes into consideration all the health hazards of substances contained in the preparation. For that purpose the dangerous health effects have been subdivided into:






1.


acute lethal effects;










2.


non-lethal irreversible effects after a single exposure;










3.


severe effects after repeated or prolonged exposure;










4.


corrosive effects, irritant effects;










5.


sensitising effects;










6.


carcinogenic effects, mutagenic effects, toxic effects for reproduction.




The health effects of a preparation are to be assessed in accordance with Article 6(1)(a) by the conventional method described in Parts A and B of this Annex using individual concentration limits:






(a)


where the dangerous substances listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 are assigned concentration limits necessary for the application of the method of assessment described in Part A of this Annex, these concentration limits must be used;










(b)


where the dangerous substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear there without the concentration limits necessary for the application of the method of evaluation described in Part A of this Annex, the concentration limits must be assigned in accordance with the specifications in Part B of this Annex.




The procedure for classification is set out in Part A of this Annex.
The classification of the substance(s) and the resulting classification of the preparation are expressed:






—


either by a symbol and one or more risk phrases, or










—


by categories (category 1, category 2 or category 3) also assigned risk phrases when substances and preparations are shown to be carcinogenic, mutagenic or toxic for reproduction. Therefore it is important to consider, in addition to the symbol, all the phrases denoting specific risks which are assigned to each substance under consideration.




The systematic assessment of all the dangerous health effects is expressed by means of concentration limits, expressed as a weight/weight percentage except for gaseous preparations where they are expressed as a volume/volume percentage and in conjunction with the classification of the substance.
Where they are not given in Part 3 of Annex VI to Regulation (EC) No 1272/2008 , the concentration limits to be taken into account for the application of this conventional method are those set out in Part B of this Annex.

PART A


Procedure for evaluation of health hazards

The evaluation proceeds stepwise as follows:

1.   The following preparations are to be classified as very toxic:









1.1.


owing to their acute lethal effects and assigned the symbol ‘T+’, the indication of danger ‘very toxic’ and the risk phrases R26, R27 or R28:












1.1.1.


preparations containing one or more substances classified as very toxic that produce such effects, in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















1.1.2.


preparations containing more than one substance classified as very toxic in lower individual concentrations than the limits specified in point 1.1.1(a) or (b) if:




where:








PT+



=


is the percentage by weight or by volume of each very toxic substance in the preparation,




LT+



=


is the very toxic limit specified for each very toxic substance, expressed as a percentage by weight or by volume;
















1.2.


owing to their non-lethal irreversible effects after a single exposure and assigned the symbol ‘T+’, the indication of danger ‘very toxic’ and the risk phrase R39/route of exposure.
Preparations containing at least one dangerous substance that produces such effects in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits.









2.   The following preparations shall be classified as toxic:









2.1.


owing to their acute lethal effects and assigned the symbol ‘T’, the indication of danger ‘toxic’ and the risk phrases R23, R24 or R25;












2.1.1.


preparations containing one or more substances classified as very toxic or toxic that produce such effects in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















2.1.2.


preparations containing more than one substance classified as very toxic or toxic in lower individual concentrations than the limits specified in point 2.1.1(a) or (b) if:




where:








PT+



=


is the percentage by weight or by volume of each very toxic substance in the preparation,




PT



=


is the percentage by weight or by volume of each toxic substance in the preparation,




LT



=


is the respective toxic limit specified for each very toxic or toxic substance, expressed as a percentage by weight or by volume;
















2.2


owing to their non-lethal irreversible effects after a single exposure and assigned the symbol ‘T’, the indication of danger ‘toxic’ and the risk phrase R39/route of exposure.
Preparations containing at least one dangerous substance classified as very toxic or toxic that produce such effects in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















2.3.


owing to their long-term effects and assigned the symbol ‘T’, the indication of danger ‘toxic’ and the risk phrase R48/route of exposure.
Preparations containing at least one dangerous substance that produces such effects in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 3 in Part B of this Annex (Table 3 and 3a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits.









3.   The following preparations shall be classified as harmful:









3.1.


owing to their acute lethal effects and assigned the symbol ‘Xn’ and the indication of danger ‘harmful’ and the risk phrases R20, R21 or R22;












3.1.1.


preparations containing one or more substances classified as very toxic, toxic or harmful and that produce such effects in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















3.1.2.


preparations containing more than one substance classified as very toxic, toxic or harmful in lower individual concentrations than the limits specified in point 3.1.1(a) or (b) if:




where:








PT+



=


is the percentage by weight or by volume of each very toxic substance in the preparation,




PT



=


is the percentage by weight or by volume of each toxic substance in the preparation,




PXn



=


is the percentage by weight or by volume of each harmful substance in the preparation,




LXn



=


is the respective harmful limit specified for each very toxic, toxic or harmful substance, expressed as percentage by weight or by volume;
















3.2.


owing to their acute effects to the lungs if swallowed and assigned the symbol ‘Xn’, and the indication of danger ‘harmful’ and the risk phrase R65.




Preparations classified as harmful according to the criteria specified in point 3.2.3 of Annex VI to Directive 67/548/EEC. In applying the conventional method in accordance with point 3.1 of this Part no account shall be taken of the classification of a substance as R65;








3.3.


owing to their non-lethal irreversible effects after a single exposure and assigned the symbol ‘Xn’, the indication of danger ‘harmful’ and the risk phrase 1 R68/route of exposure.
Preparations containing at least one dangerous substance classified as very toxic, toxic or harmful that produces such effects in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















3.4.


owing to their long-term effects and assigned the symbol ‘Xn’, the indication of danger ‘harmful’ and the risk phrase R48/route of exposure.
Preparations containing at least one dangerous substance classified as toxic or harmful that produces such effects in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 3 in Part B of this Annex (Table 3 and 3a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits.









4.   The following preparations are to be classified as corrosive:









4.1.


and assigned the symbol ‘C’, the indication of danger ‘corrosive’ and the risk phrase R35;












4.1.1.


preparations containing one or more substances classified as corrosive to which is assigned the phrase R35 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















4.1.2.


preparations containing more than one substance classified as corrosive to which is assigned phrase R35 in lower individual concentrations than the limits specified in point 4.1.1(a) or (b) if:




where:








PC, R35



=


is the percentage by weight or by volume of each corrosive substance which is assigned phrase R35 in the preparation,




LC, R35



=


is the corrosive limit R35 specified for each corrosive substance to which is assigned phrase R35, expressed as a percentage by weight or by volume;
















4.2.


and assigned the symbol ‘C’, the indication of danger ‘corrosive’ and the risk phrase R34;












4.2.1.


preparations containing one or more substances classified as corrosive to which is assigned the phrase R35 or R34 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















4.2.2.


preparations containing more than one of the substances classified as corrosive to which is assigned the phrase R35 or R34 in lower individual concentrations than the limits specified in point 4.2.1(a) or (b) if:




where:








PC, R35



=


is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,




PC, R34



=


is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,




LC, R34



=


is the respective corrosive limit R34 specified for each corrosive substance to which is assigned phrase R35 or R34, expressed as a percentage by weight or by volume.









5.   The following preparations are to be classified as irritants:









5.1.


liable to cause serious eye damage and assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R41;












5.1.1.


preparations containing one or more substances classified as irritant to which is assigned phrase R41 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















5.1.2.


preparations containing more than one of the substances classified as irritant and to which is assigned phrase R41, or classified as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits specified in point 5.1.1(a) or (b) if:




where:








PC, R35



=


is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,




PC, R34



=


is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,




PXi, R41



=


is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41 in the preparation,




LXi, R41



=


is the respective irritant limit R41 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, expressed as percentage by weight or by volume;
















5.2.


irritant to eyes and assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R36;












5.2.1.


preparations containing one or more substances classified as corrosive to which is assigned phrase R35 or R34 or as irritant and to which is assigned phrase R41 or R36 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















5.2.2.


preparations containing more than one substance classified as irritant to which is assigned phrase R41 or R36, or as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits specified in point 5.2.1(a) or (b) if:




where:








PC, R35



=


is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,




PC, R34



=


is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,




PXi, R41



=


is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41 in the preparation,




PXi, R36



=


is the percentage by weight or by volume of each irritant substance to which is assigned phrase R36 in the preparation,




LXi, R36



=


is the respective irritant limit R36 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, or R36 expressed as percentage by weight or by volume;
















5.3.


irritant to skin and assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R38;












5.3.1.


preparations containing one or more substances classified as irritant and to which is assigned phrase R38 or as corrosive and to which is assigned phrase R35 or R34 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















5.3.2.


preparations containing more than one of the substances classified as irritant and to which is assigned phrase R38, or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than the limits specified in point 5.3.1(a) or (b) if:




where:








PC, R35



=


is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,




PC, R34



=


is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,




PXi, R38



=


is the percentage by weight or by volume of each irritant substance to which is assigned phrase R38 in the preparation,




LXi, R38



=


is the respective irritant limit R38 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R38, expressed as percentage by weight or by volume;
















5.4.


irritant to respiratory system and assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R37;












5.4.1.


preparations containing one or more substances classified as irritant and to which is assigned phrase R37 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or the substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















5.4.2.


preparations containing more than one substance classified as irritant and to which is assigned phrase R37 in lower individual concentrations than the limits specified in point 5.4.1(a) or (b) if:




where:








PXi, R37



=


is the percentage by weight or by volume of each irritant substance to which is assigned phrase R37 in the preparation,




LXi, R37



=


is the irritant limit R37 specified for each irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume;
















5.4.3.


gaseous preparations containing more than one of the substances classified as irritant to which is assigned phrase R37 or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than the limits specified in point 5.4.1(a) or (b) if:




where:








PC, R35



=


is the percentage by volume of each corrosive substance to which is assigned phrase R35 in the preparation,




PC, R34



=


is the percentage by volume of each corrosive substance to which is assigned phrase R34 in the preparation,




PXi, R37



=


is the percentage by volume of each irritant substance to which is assigned phrase R37 in the preparation,




LXi, R37



=


is the respective irritant limit R37 specified for each gaseous corrosive substance to which is assigned phrase R35 or R34 or gaseous irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume.









6.   The following preparations are to be classified as sensitising:









6.1.


by skin contact and assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R43.
Preparations containing at least one substance classified as sensitising and to which is assigned phrase R43 that produces such effects in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 5 in Part B of this Annex (Table 5 and 5a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















6.2.


by inhalation and assigned the symbol ‘Xn’, the indication of danger ‘harmful’ and the risk phrase R42.
Preparations containing at least one substance classified as sensitising to which is assigned phrase R42 that produces such effects in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 5 in Part B of this Annex (Table 5 and 5a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits.









7.   The following preparations are to be classified as carcinogenic:









7.1.


those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R45 or R49.
Preparations containing at least one substance producing such effects, classified as carcinogenic and to which is assigned phrase R45 or R49 which denotes carcinogenic substances in category 1 and category 2, in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















7.2.


those of category 3 which are assigned the symbol ‘Xn’ and the phrase R40.
Preparations containing at least one substance producing such effects classified as carcinogenic and to which is assigned phrase R40 which denotes carcinogenic substances in category 3, in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits.









8.   The following preparations are to be classified as mutagenic:









8.1.


those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R46.
Preparations containing at least one substance producing such effects, classified as mutagenic and to which is assigned phrase R46 which denotes mutagenic substances in category 1 and category 2, in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















8.2.


those of category 3 which are assigned the symbol ‘Xn’ and the phrase 1 R68 .
Preparations containing at least one substance, producing such effects, classified as mutagenic and to which is assigned phrase 1 R68 which denotes mutagenic substances in category 3, in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits.









9.   The following preparations are to be classified as toxic for reproduction:









9.1.


those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R60 (fertility).
Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R60 which denotes substances toxic for reproduction of category 1 and category 2, in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















9.2.


those of category 3 which are assigned the symbol ‘Xn’ and the phrase R62 (fertility).
Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R62 which denotes substances toxic for reproduction of category 3, in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















9.3.


those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R61 (development).
Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R61 which denotes substances toxic for reproduction of category 1 and category 2, in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















9.4.


those of category 3 which are assigned the symbol ‘Xn’ and the phrase R63 (development).
Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R63 which denotes substances toxic for reproduction of category 3, in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits.









PART B


Concentration limits to be used in evaluation of health hazards

For each health effect, the first table (Tables 1 to 6) sets out the concentration limits (expressed as a weight/weight percentage) to be used for non-gaseous preparations and the second table (Tables 1a to 6a) sets out the concentration limits (expressed as a volume/volume percentage) to be used for gaseous preparations. These concentration limits are used in the absence of specific concentration limits for the substance under consideration in Part 3 of Annex VI to Regulation (EC) No 1272/2008 .

1.   Acute lethal effects


1.1.   Non-gaseous preparations

The concentration limits fixed in Table 1, expressed as a weight/weight percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Table 1









Classification of the substance


Classification of the preparation




T+



T


Xn





T+ with R26, R27, R28


concentration ≥ 7 %


1 % ≤ concentration < 7 %


0,1 % ≤ concentration < 1 %




T with R23, R24, R25


 


concentration ≥ 25 %


3 % ≤ concentration < 25 %




Xn with R20, R21, R22


 


 


concentration ≥ 25 %




The R phrases denoting risk are to be assigned to the preparation in accordance with the following criteria:






—


the label shall include one or more of the abovementioned R phrases according to the classification used,










—


in general, the R phrases selected should be those applicable to the substance(s) present in the concentration which gives rise to the most severe classification.





1.2.   Gaseous preparations

The concentration limits expressed as a volume/volume percentage in Table 1a determine the classification of the gaseous preparations in relation to the individual concentration of the gas(es) present whose classification is also shown.

Table 1a









Classification of the substance (gas)


Classification of the gaseous preparation




T+



T


Xn





T+ with R26, R27, R28


concentration ≥ 1 %


0,2 % ≤ concentration < 1 %


0,02 % ≤ concentration < 0,2 %




T with R23, R24, R25


 


concentration ≥ 5 %


0,5 % ≤ concentration < 5 %




Xn with R20, R21, R22


 


 


concentration ≥ 5 %




The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria:






—


the label shall include one or more of the abovementioned R phrases according to the classification used,










—


in general, the R phrases selected should be those applicable to the substance(s) present in the concentration which gives rise to the most severe classification.





2.   Non-lethal irreversible effects after a single exposure


2.1.   Non-gaseous preparations

For substances that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, 1 R68/route of exposure), the individual concentration limits specified in Table 2, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table 2









Classification of the substance


Classification of the preparation




T+



T


Xn





T+ with R39/route of exposure


concentration ≥ 10 % R39 (1) obligatory


1 % ≤ concentration < 10 % R39 (1) obligatory


0,1 % ≤ concentration < 1 % 1 R68 (1) obligatory




T with R39/route of exposure


 


concentration ≥ 10 % R39 (1) obligatory


1 % ≤ concentration < 10 % 1 R68 (1) obligatory




Xn with 1 R68/route of exposure


 


 


concentration ≥ 10 % 1 R68 (1) obligatory





2.2.   Gaseous preparations

For gases that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, 2 R68/route of exposure), the individual concentration limits specified in Table 2a, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table 2a









Classification of the substance (gas)


Classification of the gaseous preparation




T+



T


Xn





T+ with R39/route of exposure


concentration ≥ 1 % R39 (2) obligatory


0,2 % ≤ concentration < 1 % R39 (2) obligatory


0,02 % ≤ concentration < 0,2 % 2 R68 (2) obligatory




T with R39/route of exposure


 


concentration ≥ 5 % R39 (2) obligatory


0,5 % ≤ concentration < 5 % 2 R68 (2) obligatory




Xn with 2 R68/route of exposure


 


 


concentration ≥ 5 % 2 R68 (2) obligatory





3.   Severe effects after repeated or prolonged exposure


3.1.   Non-gaseous preparations

For substances that produce severe effects after repeated or prolonged exposure (R 48/route of exposure), the individual concentration limits specified in Table 3, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table 3








Classification of the substance


Classification of the preparation




T


Xn





T with R48/route of exposure


concentration ≥ 10 % R48 (3) obligatory


1 % ≤ concentration < 10 % R48 (3) obligatory




Xn with R48/route of exposure


 


concentration ≥ 10 % R48 (3) obligatory





3.2.   Gaseous preparations

For gases that produce severe effects after repeated or prolonged exposure (R48/route of exposure), the individual concentration limits specified in Table 3a, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table 3a








Classification of the substance (gas)


Classification of the gaseous preparation




T


Xn





T with R48/route of exposure


concentration ≥ 5 % R48 (4) obligatory


0,5 % ≤ concentration < 5 % R48 (4) obligatory




Xn with R48/route of exposure


 


concentration ≥ 5 % R48 (4) obligatory





4.   Corrosive and irritant effects including serious damage to the eye


4.1.   Non-gaseous preparations

For substances that produce corrosive effects (R34, R35) or irritant effects (R36, R37, R38, R41), the individual concentration limits specified in Table 4, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table 4










Classification of the substance


Classification of the preparation




C with R35


C with R34


Xi with R41


Xi with R36, R37, R38




C with R35


concentration ≥ 10 % R35 obligatory


5 % ≤ concentration < 10 % R34 obligatory


5 % (5)



1 % ≤ concentration < 5 % R36/38 obligatory




C with R34


 


concentration ≥ 10 % R34 obligatory


10 % (5)



5 % ≤ concentration < 10 % R36/38 obligatory




Xi with R41


 


 


concentration ≥ 10 % R41 obligatory


5 % ≤ concentration < 10 % R36 obligatory




Xi with R36, R37, R38


 


 


 


concentration ≥ 20 % R36, R37, R38 are obligatory in the light of the concentration present if they apply to the substances under consideration











NB:



Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in point 3.2.5 of Annex VI to Directive 67/548/EEC and in the second and third indents of Article 6(3), of this Directive.





4.2.   Gaseous preparations

For gases that produce such effects (R34, R35 or R36, R37, R38, R41), the individual concentration limits specified in Table 4a, expressed as a volume/volume percentage determine, when appropriate, the classification of the preparation.

Table 4a










Classification of the substance (gas)


Classification of the gaseous preparation




C with R35


C with R34


Xi with R41


Xi with R36, R37, R38




C with R35


concentration ≥ 1 % R35 obligatory


0,2 % ≤ concentration < 1 % R34 obligatory


0,2 % (6)



0,02 % ≤ concentration < 0,2 % R36/37/38 obligatory




C with R34


 


concentration ≥ 5 % R34 obligatory


5 % (6)



0,5 % ≤ concentration < 5 % R36/37/38 obligatory




Xi with R41


 


 


concentration ≥ 5 % R41 obligatory


0,5 % ≤ concentration < 5 % R36 obligatory




Xi with R36, R37, R38


 


 


 


concentration ≥ 5 % R36, R37, R38 obligatory as appropriate











NB:



Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in point 3.2.5 of Annex VI to Directive 67/548/EEC and in the second and third indents of Article 6(3), of this Directive.





5.   Sensitising effects


5.1.   Non-gaseous preparations

Preparations that produce such effects are classified as sensitising and assigned:






—


the symbol Xn and phrase R42 if this effect can be produced by inhalation,










—


the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.




The individual concentration limits specified in Table 5, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table 5








Classification of the substance


Classification of the preparation




Sensitising with R42


Sensitising with R43




Sensitising with R42


concentration ≥ 1 % R42 obligatory


 




Sensitising with R43


 


concentration ≥ 1 % R43 obligatory





5.2.   Gaseous preparations

Gaseous preparations that produce such effects are classified as sensitising and assigned:






—


the symbol Xn and phrase R42 if this effect can be produced by inhalation,










—


the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.




The individual concentration limits specified in Table 5a, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table 5a








Classification of the substance (gas)


Classification of the gaseous preparation




Sensitising with R42


Sensitising with R43




Sensitising with R42


concentration ≥ 0,2 % R42 obligatory


 




Sensitising with R43


 


concentration ≥ 0,2 % R43 obligatory





6.   Carcinogenic/mutagenic/toxic effects for reproduction


6.1.   Non-gaseous preparations

For substances which produce such effects, the concentration limits laid down in Table 6, expressed as a weight/weight percentage, shall determine, where appropriate, the classification of the preparation. The following symbol and risk phrases are assigned:






Carcinogenic categories 1 and 2:


T; R45 or R49




Carcinogenic category 3:


Xn; R40




Mutagenic categories 1 and 2:


T; R46




Mutagenic category 3:


Xn; 1 R68




Toxic for reproduction fertility categories 1 and 2:


T; R60




Toxic for reproduction development categories 1 and 2:


T; R61




Toxic for reproduction fertility category 3:


Xn; R62




Toxic for reproduction development category 3:


Xn; R63








Table 6








Classification of the substance


Classification of the preparation




Categories 1 and 2


Category 3




Carcinogenic substances of category 1 or 2 with R45 or R49


Concentration ≥ 0,1 % carcinogenic R45, R49 obligatory as appropriate


 




Carcinogenic substances of category 3 with R40


 


Concentration ≥ 1 % carcinogenic R40 obligatory (unless already assigned R45
 (7))




Mutagenic substances of category 1 or 2 with R46


Concentration ≥ 0,1 % mutagenic R46 obligatory


 




Mutagenic substances of category 3 with R68


 


Concentration ≥ 1 % mutagenic R68 obligatory (unless already assigned R46)




Substances ‘toxic for reproduction’ of category 1 or 2 with R60 (fertility)


Concentration ≥ 0,5 % toxic for reproduction (fertility) R60 obligatory


 




Substances ‘toxic for reproduction’ of category 3 with R62 (fertility)


 


Concentration ≥ 5 % toxic for reproduction (fertility) R62 obligatory (unless already assigned R60)




Substances ‘toxic for reproduction’ of category 1 or 2 with R61 (development)


Concentration ≥ 0,5 % toxic for reproduction (development) R61 obligatory


 




Substances ‘toxic for reproduction’ of category 3 with R63 (development)


 


Concentration ≥ 5 % toxic for reproduction (development) R63 obligatory (unless already assigned R61)





6.2.   Gaseous preparations

For gases which produce such effects, the concentration limits laid down in Table 6a, expressed as a volume/volume percentage, shall determine, where appropriate, the classification of the preparation. The following symbol and risk phrases are assigned:






Carcinogenic categories 1 and 2:


T; R45 or R49




Carcinogenic category 3:


Xn; R40




Mutagenic categories 1 and 2:


T; R46




Mutagenic category 3:


Xn; 1 R68




Toxic for reproduction fertility categories 1 and 2:


T; R60




Toxic for reproduction development categories 1 and 2:


T; R61




Toxic for reproduction fertility category 3:


Xn; R62




Toxic for reproduction development category 3:


Xn; R63








Table 6a








Classification of the substance


Classification of the preparation




Categories 1 and 2


Category 3




Carcinogenic substances of category 1 or 2 with R45 or R49


Concentration ≥ 0,1 % carcinogenic R45, R49 obligatory as appropriate


 




Carcinogenic substances of category 3 with R40


 


Concentration ≥ 1 % carcinogenic R40 obligatory (unless already assigned R45
 (8))




Mutagenic substances of category 1 or 2 with R46


Concentration ≥ 0,1 % mutagenic R46 obligatory


 




Mutagenic substances of category 3 with R68


 


Concentration ≥ 1 % mutagenic R68 obligatory (unless already assigned R46)




Substances ‘toxic for reproduction’ of category 1 or 2 with R60 (fertility)


Concentration ≥ 0,2 % toxic for reproduction (fertility) R60 obligatory


 




Substances ‘toxic for reproduction’ of category 3 with R62 (fertility)


 


Concentration ≥ 1 % toxic for reproduction (fertility) R62 obligatory (unless already assigned R60)




Substances ‘toxic for reproduction’ of category 1 or 2 with R61 (development)


Concentration ≥ 0,2 % toxic for reproduction (development) R61 obligatory


 




Substances ‘toxic for reproduction’ of category 3 with R63 (development)


 


Concentration ≥ 1 % toxic for reproduction (development) R63 obligatory (unless already assigned R61)






(1)  In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

(2)  In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

(3)  In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

(4)  In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed in points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.

(5)  According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36.

(6)  According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36.

(7)  In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.

(8)  In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.




ANNEX III



METHODS FOR THE EVALUATION OF THE ENVIRONMENTAL HAZARDS OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 7


INTRODUCTION

The systematic assessment of all the dangerous properties for the environment is expressed by means of concentration limits, expressed as a weight/weight percentage except for gaseous preparations where they are expressed as a volume/volume percentage and in conjunction with the classification of a substance.
Part A sets out the calculation procedure in accordance with Article 7(1)(a) and gives the R phrases to be assigned to the classification of the preparation.
Part B sets out the concentration limits to be used when applying the conventional method and relevant symbols and R phrases for classification.
In accordance with Article 7(1)(a) the environmental hazards of a preparation shall be assessed by the conventional method described in Parts A and B of this Annex, using individual concentration limits.






(a)


Where the dangerous substances listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 are assigned concentration limits necessary for the application of the method of assessment described in Part A of this Annex, these concentration limits must be used.










(b)


Where the dangerous substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear there without the concentration limits necessary for the application of the method of evaluation described in Part A of this Annex, the concentration limits shall be assigned in accordance with the specification in Part B of this Annex.




Part C sets out the test methods for the evaluation of the hazards for the aquatic environment.

PART A


Procedure for the evaluation of environmental hazards


(a)   Aquatic environment


I.   Conventional method for the evaluation of hazards to the aquatic environment

The conventional method for the evaluation of hazards to the aquatic environment 2 takes into account all the hazards that a preparation may entail for this medium in accordance with the following specifications.
The following preparations are to be classified as dangerous for the environment:








1.


and assigned the symbol ‘N’, the indication of danger ‘dangerous for the environment’ and the risk phrases R50 and R53 (R50-53):












1.1.


preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-53 in individual concentrations equal to or greater than:






(a)


either the concentration specified in 3 Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified in Part B of this Annex (Table 1) where the substance or substances do not appear in 3 Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















1.2.


preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrases R50–53 in lower individual concentrations than the limits specified in point I.1.1(a) or (b) if:




where:








PN, R50-53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,




LN, R50-53



=


is the limit R50–53 for each substance dangerous for the environment to which is assigned the phrases R50–53, expressed as percentage by weight;
















2.


and assigned the symbol ‘N’, the indication of danger ‘dangerous for the environment’ and the risk phrases R51 and R53 (R51–53) unless the preparation is already classified in accordance with point I.1;












2.1.


preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrases R50–53 or R51–53 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified in Part B of this Annex (Table 1) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















2.2.


preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrases R50–53 or R51–53 in lower individual concentrations than the limits specified in point I.2.1 (a) or (b) if:




where:








PN, R50-53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,




PN, R51-53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51–53 in the preparation,




LN, R51-53



=


is the respective limit R51–53 for each substance dangerous for the environment to which is assigned phrases R50–53 or R51–53, expressed as percentage by weight;
















3.


and assigned the risk phrases R52 and R53 (R52–53) unless the preparation is already classified in accordance with point I.1 or I.2;












3.1.


preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrases R50–53 or R51–53 or R52–53 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified in Part B of this Annex (Table 1) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















3.2.


preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrases R51–53 or R50–53 or R52–53 in lower individual concentrations than the limits specified in point I.3.1(a) or (b) if:




where:








PN, R50-53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,




PN, R51-53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51–53 in the preparation,




PR52-53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R52–53 in the preparation,




LR52-53



=


is the respective limit R52–53 for each substance dangerous for the environment to which is assigned phrases R50–53 or R51–53 or R52–53, expressed as percentage by weight;
















4.


and assigned the symbol ‘N’, the indication of danger ‘dangerous for the environment’ and the risk phrase R50 unless the preparation is already classified in accordance with point I.1:












4.1.


preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R50 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified in Part B of this Annex (Table 2) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















4.2.


preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R50 in lower individual concentrations than the limits specified in point I.4.1(a) or (b) if:




where:








PN, R50



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,




LN, R50



=


is the limit R50 for each substance dangerous for the environment to which is assigned phrase R50, expressed as percentage by weight;
















4.3.


preparations containing one or more than one of the substances classified as dangerous for the environment and to which is assigned phrase R50 not meeting the criteria in point I.4.1 or I.4.2 and containing one or more than one substance classified as dangerous for the environment and to which is assigned phrases R50–53 if:




where:








PN, R50



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,




PN, R50-53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50–53 in the preparation,




LN, R50



=


is the perspective limit R50 for each substance dangerous for the environment to which is assigned phrases R50 or R50–53, expressed as percentage by weight;
















5.


and assigned the risk phrase R52 unless the preparation is already classified in accordance with point I.1, I.2, I.3, or I.4:












5.1.


preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R52 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified in Part B of this Annex (Table 3) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















5.2.


preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R52 in lower individual concentrations than the limits specified in point I.5.1 (a) or (b) if:




where:








PR52



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52 in the preparation,




LR52



=


is the limit R52 for each substance dangerous for the environment to which is assigned phrase R52, expressed as percentage by weight;
















6.


and assigned the risk phrase R53 unless the preparation is already classified in accordance with point I.1, I.2, or I.3:












6.1.


preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R53 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified in Part B of this Annex (Table 4) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits;
















6.2.


preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R53 in lower individual concentrations than the limits specified in point I.6.1(a) or (b) if:




where:








PR53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,




LR53



=


is the limit R53 for each substance dangerous for the environment to which is assigned phrase R53, expressed as percentage by weight;
















6.3.


preparations containing one or more than one of the substances classified as dangerous for the environment and to which is assigned phrase R53 not meeting the criteria in point I.6.2 and containing one or more than one substance classified as dangerous for the environment and to which is assigned phrases R50–53 or R51–53 or R52–53 if:




where:








PR53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,




PN, R50-53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50–53 in the preparation,




PN, R51-53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R51–53 in the preparation,




PR52-53



=


is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52–53 in the preparation,




LR53



=


is the respective limit R53 for each substance dangerous for the environment to which is assigned phrase R53 or R50–53 or R51–53 or R52–53, expressed as percentage by weight.









(b)   Non-aquatic environment


(1)   OZONE LAYER

I.   Conventional method for the evaluation of preparations dangerous for the ozone layer
The following preparations shall be classified as dangerous for the environment:








1.


and assigned the symbol ‘N’, the indication of danger ‘dangerous for the environment’ and the risk phrase R59;












1.1.


preparations containing one or more substances classified as dangerous to the environment and to which is assigned the symbol ‘N’ and the risk phrase R59 in individual concentrations equal to or greater than:






(a)


either the concentration specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance or substances under consideration, or










(b)


the concentration specified in Part B of this Annex (Table 5) where the substance or substances do not appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 or appear in it without concentration limits.









(2)   TERRESTRIAL ENVIRONMENT

I.   Evaluation of preparations dangerous for the terrestrial environment
Classification of preparations using the risk phrases below will follow after the detailed criteria for use of the phrases have been incorporated in Annex VI to Directive 67/548/EEC.






R54


Toxic to flora




R55


Toxic to fauna




R56


Toxic to soil organisms




R57


Toxic to bees




R58


May cause long-term adverse effects in the environment.





PART B


Concentration limits to be used for the evaluation of environmental hazards


I.   For the aquatic environment

The concentration limits fixed in the following tables, expressed as a weight/weight percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Table 1a


Acute aquatic toxicity and long-term adverse effects









Classification of the substance


Classification of the preparation




N, R50-53


N, R51-53


R52-53




N, R50-53


see Table 1b


see Table 1b


see Table 1b




N, R51-53


 


Cn ≥ 25 %


2,5 % ≤ Cn< 25 %




R52-53


 


 


Cn ≥ 25 %




Preparations containing a substance classified with N, R50–53, the concentration limits and the resulting classification given in table 1b are applicable.

Table 1b


Acute aquatic toxicity and long-term adverse effects of substances very toxic to the aquatic environment









LC50 or EC50 value (‘L(E)C50’) of substance classified as N, R50–53 (mg/l)


Classification of the preparation




N, R50-53


N, R51-53


R52-53




0,1 < L(E)C50 ≤ 1


Cn ≥ 25 %


2,5 % ≤ Cn< 25 %


0,25 % ≤ Cn< 2,5 %




0,01 < L(E)C50 ≤ 0,1


Cn ≥ 2,5 %


0,25 % ≤ Cn< 2,5 %


0,025 % ≤ Cn< 0,25 %




0,001 < L(E)C50 ≤ 0,01


Cn ≥ 0,25 %


0,025 % ≤ Cn< 0,25 %


0,0025 % ≤ Cn< 0,025 %




0,0001 < L(E)C50 ≤ 0,001


Cn ≥ 0,025 %


0,0025 % ≤ Cn< 0,025 %


0,00025 % ≤ Cn< 0,0025 %




0,00001 < L(E)C50 ≤ 0,0001


Cn ≥ 0,0025 %


0,00025 % ≤ Cn< 0,0025 %


0,000025 % ≤ Cn< 0,00025 %




For preparations containing substances with a lower LC50 or EC50 value than 0,00001 mg/l, the corresponding concentrationlimits are calculated accordingly (in factor 10 intervals).








Table 2


Acute aquatic toxicity







LC50 or EC50 value (‘L(E)C50’) of substance classified either as N, R50 or as N, R50-53 (mg/l)


Classification of the preparation N, R50




0,1 < L(E)C50 ≤ 1


Cn ≥ 25 %




0,01 < L(E)C50 ≤ 0,1


Cn ≥ 2,5 %




0,001 < L(E)C50 ≤ 0,01


Cn ≥ 0,25 %




0,0001 < L(E)C50 ≤ 0,001


Cn ≥ 0,025 %




0,00001 < L(E)C50 ≤ 0,0001


Cn ≥ 0,0025 %




For preparations containing substances with a lower LC50 or EC50 value than 0,00001 mg/l, the corresponding concentration limits are calculated accordingly (in factor 10 intervals).








Table 3


Aquatic toxicity







Classification of the substance


Classification of the preparation R52




R52


Cn ≥ 25 %








Table 4


Long-term adverse effects







Classification of the substance


Classification of the preparation R53




R53


Cn ≥ 25 %




N, R50-53


Cn ≥ 25 %




N, R51-53


Cn ≥ 25 %




R52-53


Cn ≥ 25 %





II.   For the non-aquatic environment

The concentration limits fixed in the following tables, expressed as weight/weight percentage or, for gaseous preparations as a volume/volume percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Table 5


Dangerous for the ozone layer







Classification of the substance


Classification of the preparation N, R59




N with R59


Cn ≥ 0,1 %





PART C


Test methods for the evaluation of the hazards for the aquatic environment

Normally, the classification of a preparation is made on the basis of the conventional method. However, for the determination of the acute aquatic toxicity, there may be cases for which it is appropriate to carry out tests on the preparation.
The result of these tests on the preparation may only modify the classification concerning acute aquatic toxicity which would have been obtained by the application of the conventional method.
If such tests are chosen by the person responsible for the placing on the market, it must be ensured that the quality criteria of the test methods in Part C of the Annex to Regulation (EC) No 440/2008 have been complied with.
Furthermore, the tests are to be carried out on all three species in conformity with the criteria of Annex VI to Directive 67/548/EEC (algae, daphnia and fish), unless the highest hazard classification relating to acute aquatic toxicity has been assigned to the preparation after testing on one of the species or a test result was already available before this Directive entered into force.




ANNEX IV



SPECIAL PROVISIONS FOR CONTAINERS CONTAINING PREPARATIONS OFFERED OR SOLD TO THE GENERAL PUBLIC


PART A


Containers to be fitted with child-resistant fastenings









1.


Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic or corrosive in accordance with Article 10 and under the conditions laid down in Article 6, are to be fitted with child-resistant fastenings.












2.


Containers of whatever capacity containing preparations presenting an aspiration hazard (Xn, R65) and classified and labelled in accordance with point 3.2.3 of Annex VI to Directive 67/548/EEC with the exception of preparations placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment.












3.


Containers of whatever capacity, having at least one of the substances mentioned below present in a concentration equal to or greater then the maximum individual concentration specified,









No


Identification of the substance


Concentration limit




CAS-Reg No


Name


Einecs No




1


67-56-1


Methanol


2 006 596


≥ 3 %




2


75-09-2


Dichloromethane


2 008 389


≥ 1 %




which are offered or sold to the general public are to be fitted with child-resistant fastenings.





PART B


Containers to be fitted with a tactile warning of danger

Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic, corrosive, harmful, extremely flammable or highly flammable in accordance with Article 10 and under the conditions laid down in Articles 5 and 6,are to carry a tactile warning of danger.
This provision does not apply to aerosols classified and labelled only as extremely flammable or highly flammable.




ANNEX V



SPECIAL PROVISIONS CONCERNING THE LABELLING OF CERTAIN PREPARATIONS


A.   For preparations classified as dangerous within the meaning of Articles 5, 6 and 7


1.   Preparations sold to the general public









1.1.


The label on the packaging containing such preparations, in addition to the specific safety advice, must bear the relevant safety advice S1, S2, S45 or S46 in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.












1.2.


When such preparations are classified as very toxic (T+), toxic (T) or corrosive (C) and where it is physically impossible to give such information on the package itself, packages containing such preparations must be accompanied by precise and easily understandable instructions for use including, where appropriate, instructions for the destruction of the empty package.





2.   Preparations intended for use by spraying

The label on the packaging containing such preparations must compulsorily bear the safety advice S23 accompanied by safety advice S38 or S51 assigned to it in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.

3.   Preparations containing a substance assigned phrase R33: Danger of cumulative effects

When a preparation contains at least one substance assigned the phrase R33, the label on the packaging of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the concentration of this substance present in the preparation is equal to or higher than 1 %, unless different values are set in Part 3 of Annex VI to Regulation (EC) No 1272/2008 .

4.   Preparations containing a substance assigned phrase R64: May cause harm to breastfed babies

When a preparation contains at least one substance assigned phrase R64, the label on the packaging of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the concentration of this substance present in the preparation is equal to or higher than 1 %, unless different values are set in Part 3 of Annex VI to Regulation (EC) No 1272/2008 .

B.   For preparations irrespective of their classification within the meaning of Articles 5, 6 and 7


1.   Preparations containing lead









1.1.


Paint and varnishes
The label on the packaging of paints and varnishes containing lead in quantities exceeding 0,15 % (expressed as weight of metal) of the total weight of the preparation, as determined in accordance with ISO standard 6503/1984, must show the following particulars:
‘Contains lead. Should not be used on surfaces liable to be chewed or sucked by children’.
In the case of packages the contents of which are less than 125 millilitres, the particulars may be as follows:
‘Warning! Contains lead’.





2.   Preparations containing cyanoacrylates









2.1.


Adhesives
The label on the immediate packaging of adhesives based on cyanoacrylate must bear the following inscriptions:
‘Cyanoacrylate.
Danger.
Bonds skin and eyes in seconds.
Keep out of the reach of children’.
Appropriate advice on safety must accompany the package.





3.   Preparations containing isocyanates

The label on the packaging of preparations containing isocyanates (as monomers, oligomers, prepolymers, etc., or as mixtures thereof) must bear the following inscriptions:

‘Contains isocyanates.
See information supplied by the manufacturer’.


4.   Preparations containing epoxy constituents with an average molecular weight ≤ 700

The label on the packaging of preparations containing epoxy constituents with an average molecular weight ≤ 700 must bear the following inscriptions:

‘Contains epoxy constituents.
See information supplied by the manufacturer’.


5.   Preparations sold to the general public which contain active chlorine

The label on the packaging of preparations containing more than 1 % of active chlorine must bear the following particular inscriptions:

‘Warning! Do not use together with other products. May release dangerous gases (chlorine)’.


6.   Preparations containing cadmium (alloys) and intended to be used for brazing or soldering

The label on the packaging of the above mentioned preparations must bear the following inscription printed in clearly legible and indelible characters:

‘Warning! Contains cadmium.
Dangerous fumes are formed during use.
See information supplied by the manufacturer.
Comply with the safety instructions’.


7.   Preparations available as aerosols

Without prejudice to the provisions of this Directive, preparations available as aerosols are also subject to the labelling provisions in accordance with points 2.2 and 2.3 of the Annex to Directive 75/324/EEC.

8.   Preparations containing substances not yet tested completely

Where a preparation contains at least one substance which, in accordance with Directive 67/548/EEC, bears the inscription 2 ‘Caution — substance not yet fully tested’, the label on the packaging of the preparation must bear the inscription <BRK>‘Warning — this preparation contains a substance not yet tested completely’ if this substance is present in a concentration ≥ 1 %.

9.   Preparations not classified as sensitising but containing at least one sensitising substance

The label on the packaging of preparations containing at least one substance classified as sensitising and being present in a concentration equal to or greater than 0,1 % or in a concentration equal to or greater than that specified under a specific note for the substance in 3 Part 3 of Annex VI to Regulation (EC) No 1272/2008 must bear the inscription:

‘Contains (name of sensitising substance). May produce an allergic reaction’.


10.   Liquid preparations containing halogenated hydrocarbons

For liquid preparations which show no flashpoint or a flashpoint higher than 55 oC and contain a halogenated hydrocarbon and more than 5 % flammable or highly flammable substances, the label on the packaging must bear the following inscription as appropriate:

‘Can become highly flammable in use’ or ‘Can become flammable in use’.


11.   Preparations containing a substance assigned phrase R67: vapours may cause drowsiness and dizziness

When a preparation contains one or more substances assigned the phrase R67, the label on the packaging of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the total concentration of these substances present in the preparation is equal to or higher than 15 %, unless:






—


the preparation is already classified with phrases R20, R23, R26, R68/20, R39/23 or R39/26,










—


or the preparation is in a package not exceeding 125 ml.





12.   Cements and cement preparations

The label on the packaging of cements and cement preparations containing more than 0,0002 % soluble chromium (VI) of the total dry weight of the cement must bear the inscription:

‘Contains chromium (VI). May produce an allergic reaction’

unless the preparation is already classified and labelled as a sensitiser with phrase R43.

C.   For preparations not classified within the meaning of Articles 5, 6 and 7 but containing at least one dangerous substance


1.   Preparations not intended for the general public

The label on the packaging of preparations referred to in Article 31(3)(a) and (c) of Regulation (EC) No 1907/2006 must bear the following inscription:

‘Safety data sheet available for professional user on request’.





ANNEX VI



CONFIDENTIALITY FOR THE CHEMICAL IDENTITY OF A SUBSTANCE


PART A


Information to be communicated in the request for confidentiality


Introductory notes







A.


Article 14 indicates the conditions in which the person responsible for placing a preparation on the market may avail himself of the confidentiality.










B.


To avoid multiple requests for confidentiality relating to the same substance used in different preparations, a single request for confidentiality may suffice if a certain number of preparations have:






—


the same dangerous constituents present in the same concentration range,










—


the same classification and labelling,










—


the same expected uses.




A single alternative denomination must be used to mask the chemical identity of the same substance in the preparations concerned. Furthermore, the request for confidentiality must contain all information indicated in the following request, without forgetting the name or the trade name of each preparation.










C.


The alternative designation used on the label must be the same as that given under Heading 3 ‘Composition/information on ingredients’ of Annex II to Regulation (EC) No 1907/2006.
This implies that the alternative designation used will contain enough information about the substance to ensure risk-free handling.










D.


In making the request to use an alternative designation the person responsible for placing on the market must take into account the need to provide enough information for necessary health and safety precautions to be taken in the workplace and to ensure that risks from handling the preparation can be minimised.





Request for confidentiality

In accordance with Article 14 the request for confidentiality must obligatorily contain the following information:






1.


Name and full address (including telephone number) of the person established in the Union who is responsible for placing the preparation on the market (manufacturer, importer or distributor).










2.


Precise identification of the substance(s) for which confidentiality is proposed and the alternative designation.








CAS No


Einecs No


Chemical name according to international nomenclature and classification
(Part 3 of Annex VI to Regulation (EC) No 1272/2008 or provisional classification)


Alternative designation




(a)


 


 


 




(b)


 


 


 




(c)


 


 


 











NB:



Where substances are classified provisionally, accompanying information (bibliographical references) should be provided as evidence that the provisional classification takes account of all existing pertinent information available on the properties of the substance.


















3.


Justification for confidentiality (probability — plausibility).










4.


Designation(s) or commercial name(s) of the preparation(s).










5.


Is the designation or commercial name the same for all the Union?






YES


NO




If no, specify the designation(s) or commercial name(s) used in the different Member States:






 


Belgium:
Bulgaria:
Czech Republic:
Denmark:
Germany:
Estonia:
Ireland:
Greece:
Spain:
France:
Italy:










 


Cyprus:
Latvia:
Lithuania:
Luxembourg:
Hungary:
Malta:
Netherlands:
Austria:
Poland:
Portugal:
Romania:
Slovenia:
Slovakia:
Finland:










 


Sweden:
United Kingdom:














6.


Composition of the preparation(s) defined in Heading 3 of Annex II to Regulation (EC) No 1907/2006.










7.


Classification of the preparation(s) in accordance with Article 6 of this Directive.










8.


Labelling of the preparation(s) in accordance with Article 10 of this Directive.










9.


Intended uses for the preparation(s).










10.


Safety data sheet(s) conforming to Regulation (EC) No 1907/2006.





PART B


Lexicon guide for establishing the alternative designations (generic names)


1.   Introductory note

The lexicon guide is based on the procedure for the classification of dangerous substances (division of substances into families) which appears in Part 3 of Annex VI to Regulation (EC) No 1272/2008 .
Alternative designations to those based on this guide may be used. However, in all cases the names chosen must provide enough information to ensure the preparation can be handled without risk and that necessary health and safety precautions can be taken in the workplace.
The families are defined in the following manner:






—


inorganic or organic substances whose properties are identified by having a common chemical element as their chief characteristic. The family name is derived from the name of the chemical element. These families are identified as in 2 Part 3 of Annex VI to Regulation (EC) No 1272/2008 by the atomic number of the chemical element (001 to 103),










—


organic substances whose properties are identified by having a common functional group as their chief characteristics.




The family name is derived from the functional group name.
These families are identified by the conventional number found in 2 Part 3 of Annex VI to Regulation (EC) No 1272/2008 (601 — 650).
Sub-families bringing together substances with a common specific character have been added in certain cases.

2.   Establishing the generic name


General principles

For the purposes of establishing the generic name, the following general approach, involving two successive stages, is adopted:






(i)


identification of the functional groups and chemical elements present in the molecule;










(ii)


determination of the extent to which account should be taken of the most important functional groups and chemical elements.




The identified functional groups and elements taken into account are the names of the families and sub-families set out in point 3 in the form of a non-restrictive list.

3.   Division of substances into families and sub-families








Family No
Part 3 of Annex VI to Regulation (EC) No 1272/2008


Families
Sub-families




001


Hydrogen compounds




 


Hydrides




002


Helium compounds




003


Lithium compounds




004


Beryllium compounds




005


Boron compounds




 


Boranes
Borates




006


Carbon compounds




 


Carbamates
Inorganic carbon compounds
Salts of hydrogen cyanide
Urea and derivatives




007


Nitrogen compounds




 


Quaternary ammonium compounds
Acid nitrogen compounds
Nitrates
Nitrites




008


Oxygen compounds




009


Fluorine compounds




 


Inorganic fluorides




010


Neon compounds




011


Sodium compounds




012


Magnesium compounds




 


Organometallic magnesium derivatives




013


Aluminium compounds




 


Organometallic aluminium derivatives




014


Silicon compounds




 


Silicones
Silicates




015


Phosphorus compounds




 


Acid phosphorus compounds
Phosphonium compounds
Phosphoric esters
Phosphates
Phosphites
Phosphoramides and derivatives




016


Sulphur compounds




 


Acid sulphur compounds
Mercaptans
Sulphates
Sulphites




017


Chlorine compounds




 


Chlorates
Perchlorates




018


Argon compounds




019


Potassium compounds




020


Calcium compounds




021


Scandium compounds




022


Titanium compounds




023


Vanadium compounds




024


Chromium compounds




 


Chromium VI compounds




025


Manganese compounds




026


Iron compounds




027


Cobalt compounds




028


Nickel compounds




029


Copper compounds




030


Zinc compounds




 


Organometallic zinc derivatives




031


Gallium compounds




032


Germanium compounds




033


Arsenic compounds




034


Selenium compounds




035


Bromine compounds




036


Krypton compounds




037


Rubidium compounds




038


Strontium compounds




039


Yttrium compounds




040


Zirconium compounds




041


Niobium compounds




042


Molybdenum compounds




043


Technetium compounds




044


Ruthenium compounds




045


Rhodium compounds




046


Palladium compounds




047


Silver compounds




048


Cadmium compounds




049


Indium compounds




050


Tin compounds




 


Organometallic tin derivatives




051


Antimony compounds




052


Tellurium compounds




053


Iodine compounds




054


Xenon compounds




055


Caesium compounds




056


Barium compounds




057


Lanthanum compounds




058


Cerium compounds




059


Praseodymium compounds




060


Neodymium compounds




061


Promethium compounds




062


Samarium compounds




063


Europium compounds




064


Gandolinium compounds




065


Terbium compounds




066


Dysprosium compounds




067


Holmium compounds




068


Erbium compounds




069


Thulium compounds




070


Ytterbium compounds




071


Lutetium compounds




072


Hafnium compounds




073


Tantalum compounds




074


Tungsten compounds




075


Rhenium compounds




076


Osmium compounds




077


Iridium compounds




078


Platinum compounds




079


Gold compounds




080


Mercury compounds




 


Organometallic mercury derivatives




081


Thallium compounds




082


Lead compounds




 


Organometallic lead derivatives




083


Bismuth compounds




084


Polonium compounds




085


Astate compounds




086


Radon compounds




087


Francium compounds




088


Radium compounds




089


Actinium compounds




090


Thorium compounds




091


Protactinium compounds




092


Uranium compounds




093


Neptunium compounds




094


Plutonium compounds




095


Americium compounds




096


Curium compounds




097


Berkelium compounds




098


Californium compounds




099


Einsteinium compounds




100


Fermium compounds




101


Mendelevium compounds




102


Nobelium compounds




103


Lawrencium compounds




601


Hydrocarbons




 


Aliphatic hydrocarbons
Aromatic hydrocarbons
Alicyclic hydrocarbons
Polycyclic aromatic hydrocarbons (PAH)




602


Halogenated hydrocarbons (*)




 


Halogenated aliphatic hydrocarbons (*)
Halogenated aromatic hydrocarbons (*)
Halogenated alicyclic hydrocarbons (*)










(*)


Specify according to the family corresponding to halogen.








603


Alcohols and derivatives




 


Aliphatic alcohols
Aromatic alcohols
Alicyclic alcohols
Alcanolamines
Epoxy derivatives
Ethers
Glycolethers
Glycols and polyols




604


Phenols and derivatives




 


Halogenated phenol derivatives (*)










(*)


Specify according to the family corresponding to halogen.








605


Aldehydes and derivatives




 


Aliphatic aldehydes
Aromatic aldehydes
Alicyclic aldehydes
Aliphatic acetals
Aromatic acetals
Alicyclic acetals




606


Ketones and derivatives




 


Aliphatic ketones
Aromatic ketones (*)
Alicyclic ketones










(*)


Quinones included.








607


Organic acids and derivatives




 


Aliphatic acids
Halogenated aliphatic acids (*)
Aromatic acids
Halogenated aromatic acids (*)
Alicyclic acids
Halogenated alicyclic acids (*)
Aliphatic acid anhydrides
Halogenated aliphatic acid anhydrides (*)
Aromatic acid anhydrides
Halogenated aromatic acid anhydrides (*)
Alicyclic acid anhydrides
Halogenated alicyclic acid anhydrides (*)
Salts of aliphatic acid
Salts of halogenated aliphatic acid (*)
Salts of aromatic acid




 


 


Salts of halogenated aromatic acid (*)
Salts of alicyclic acid
Salts of halogenated alicyclic acid (*)
Esters of aliphatic acid
Esters of halogenated alicyclic acid (*)
Esters of aromatic acid
Esters of halogenated aromatic acid (*)
Esters of alicyclic acid
Esters of halogenated alicyclic acid (*)
Esters of glycol ether
Acrylates
Methacrylates
Lactones
Acyl halogenides










(*)


Specify according to the family corresponding to halogen.








608


Nitriles and derivatives




609


Nitro compounds




610


Chlornitrated compounds




611


Azoxy and azo compounds




612


Amine compounds




 


Aliphatic amines and derivatives
Alicyclic amines and derivatives
Aromatic amines and derivatives
Aniline and derivatives
Benzidine and derivatives




613


Heterocyclic bases and derivatives




 


Benzimidazole and derivatives
Imidazol and derivatives
Pyrethrinoids
Quinoline and derivatives
Triazine and derivatives
Triazole and derivatives




614


Glycosides and alkaloids




 


Alkaloid and derivatives
Glycosides and derivatives




615


Cyanates and isocyanates




 


Cyanates
Isocyanates




616


Amides and derivatives




 


Acetamide and derivatives
Anilides




617


Organic peroxides




647


Enzymes




648


Complex coal derivatives




 


 


Acid extract
Alkaline extract
Anthracene oil
Anthracene oil extract residue
Anthracene oil fraction
Carbolic oil
Carbolic oil extract residue
Coal liquids, liquid solvent extraction
Coal liquids, liquid solvent extraction solvents
Coal oil
Coal tar
Coal tar extract
Coal tar solids residue
Coke (coal tar) low temperature, high temperature pitch
Coke (coal tar), high temperature pitch
Coke (coal tar), mixed coal high temperature pitch
Crude benzole
Crude phenols
Crude tar bases
Distillate bases
Distillate phenols
Distillates
Distillates (coal), liquid solvent extraction, primary
Distillates (coal), solvent extraction, hydrocracked
Distillates (coal), solvent extraction, hydrocracked hydrogenated middle
Distillates (coal), solvent extraction, hydrocracked middle
Extract residues (coal), low temperature coal tar alkaline
Fresh oil
Fuels, diesel, coal solvent extraction, hydrocracked, hydrogenated
Fuels, jet aircraft, coal solvent extraction, hydrocracked, hydrogenated
Gasoline, coal solvent extraction, hydrocracked naphtha
Heat treatment products
Heavy anthracene oil
Heavy anthracene oil redistillate
Light oil
Light oil extract residues, high boiling
Light oil extract residues, intermediate boiling
Light oil extract residues, low boiling
Light oil redistillate, high boiling
Light oil redistillate, intermediate boiling
Light oil redistillate, low boiling
Methylnaphthalene oil
Methylnaphthalene oil extract residue
Naphtha (coal), solvent extraction, hydrocracked
Naphthalene oil
Naphthalene oil extract residue
Naphthalene oil redistillate
Pitch
Pitch redistillate
Pitch residue
Pitch residue, heat treated
Pitch residue, oxidised
Pyrolysis products
Redistillates
Residues (coal), liquid solvent extractions
Tar brown coal
Tar brown coal, low temperature
Tar oil, high boiling
Tar oil, intermediate boiling
Wash oil
Wash oil extract residue
Wash oil redistillate




649


Complex oil derivatives




 


Crude oil
Petroleum gas
Low boiling point naphtha
Low boiling point modified naphtha
Low boiling point cat-cracked naphtha
Low boiling point cat-reformed naphtha
Low boiling point thermally cracked naphtha
Low boiling point hydrogen treated naphtha
Low boiling point naphtha — unspecified
Straight-run kerosine
Kerosine — unspecified
Cracked gas oil
Gas oil — unspecified
Heavy fuel oil
Grease
Unrefined or mildly refined base oil
Base oil — unspecified
Distillate aromatic extract
Distillate aromatic extract (treated)
Foots oil
Slack wax
Petrolatum




650


Various substances




 


Do not use this family. Instead, use the families or sub-families mentioned above.





4.   Practical application:

After having conducted a search to see if the substance belongs to one or more families or sub-families on the list, the generic name can be established in the following way:








4.1.


If the name of a family or sub-family is sufficient to characterise the chemical elements or important functional groups, this name will be chosen as the generic name.

Examples:







—


1,4 dihydroxybenzen







family 604


:


phenols and derivatives




generic name


:


phenol derivatives














—


butanol







family 603


:


alcohols and derivatives




sub-family


:


aliphatic alcohols




generic name


:


aliphatic alcohol














—


2-Isopropoxyethanol







family 603


:


alcohols and derivatives




sub-family


:


glycolethers




generic name


:


glycolether














—


methacrylate







family 607


:


organic acids and derivatives




sub-family


:


acrylates




generic name


:


acrylate




















4.2.


If the name of a family or sub-family is not sufficient to characterise the chemical elements of important functional groups, the generic name will be a combination of the corresponding different family or sub-family names:

Examples:







—


chlorobenzene







family 602


:


halogenated hydrocarbons




sub-family


:


halogenated aromatic hydrocarbons




family 017


:


chlorine compounds




generic name


:


chlorinated aromatic hydrocarbon














—


2,3,6-trichlorophenylacetic acid







family 607


:


organic acids




sub-family


:


halogenated aromatic acids




family 017


:


chlorine compounds




generic name


:


chlorinated aromatic acid














—


1-chloro-1-nitropropane







family 610


:


chloronitrated derivatives




family 601


:


hydrocarbons




sub-family


:


aliphatic hydrocarbons




generic name


:


chlorinated aliphatic hydrocarbon














—


tetrapropyl dithiopyrophosphate







family 015


:


phosphorus compounds




sub-family


:


phosphoric esters




family 016


:


sulphur compounds




generic name


:


thiophosphoric ester















NB:



In the case of certain elements, notably metals, the name of the family or sub-family may be indicated by the words‘organic’ or ‘inorganic’.





Examples:







—


dimercury chloride







family 080


:


mercury compounds




generic name


:


inorganic mercury compound














—


barium acetate







family 056


:


barium compounds




generic name


:


organic barium compound














—


ethyl nitrite







family 007


:


nitrogen compounds




sub-family


:


nitrites




generic name


:


organic nitrite














—


sodium hydrosulphite







family 016


:


sulphur compounds




generic name


:


inorganic sulphur compound








(The examples cited are substances taken from 3 Part 3 of Annex VI to Regulation (EC) No 1272/2008 in respect of which requests for confidentiality may be submitted).








ANNEX VII



PREPARATIONS COVERED BY ARTICLE 12(2)

Preparations as specified by point 9.3 of Annex VI to Directive 67/548/EEC.




ANNEX VIII



Part A


Repealed Directive with list of its successive amendments

(referred to in Article 22)






Directive 1999/45/EC of the European Parliament and of the Council
(OJ L 200, 30.7.1999, p. 1)


 




Commission Directive 2001/60/EC
(OJ L 226, 22.8.2001, p. 5)


 




Regulation (EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1)


Only point 90 of Annex III




Council Directive 2004/66/EC
(OJ L 168, 1.5.2004, p. 35)


Only as regards the reference to Directive 1999/45/EC in Article 1 and point I.B of the Annex




Commission Directive 2006/8/EC
(OJ L 19, 24.1.2006, p. 12)


 




Council Directive 2006/96/EC
(OJ L 363, 20.12.2006, p. 81)


Only as regards the reference to Directive 1999/45/EC in Article 1 and section G of the Annex




Regulation (EC) No 1907/2006 of the European Parliament and of the Council
(OJ L 396, 30.12.2006, p. 1)


Only Article 140




Regulation (EC) No 1137/2008 of the European Parliament and of the Council
(OJ L 311, 21.11.2008, p. 1)


Only point 3.5 of the Annex




Regulation (EC) No 1272/2008 of the European Parliament and of the Council
(OJ L 353, 31.12.2008, p. 1)


Only Article 56





Part B


List of time-limits for transposition into national law

(referred to in Article 22)






Directive


Time-limit for transposition




1999/45/EC


30 July 2002




2001/60/EC


30 July 2002




2004/66/EC


1 May 2004




2006/8/EC


1 March 2007




2006/96/EC


1 January 2007








ANNEX IX



CORRELATION TABLE







Directive 1999/45/EC


This Directive




Article 1(1), introductory wording


Article 1(1)




Article 1(1), first indent


Article 1(1)




Article 1(1), second indent


Article 1(1)




Article 1(1), last wording


Article 1(1)




Article 1(2), introductory wording


Article 1(2), introductory wording




Article 1(2), first indent


Article 1(2)(a)




Article 1(2), second indent


Article 1(2)(b)




Article 1(3), introductory wording


Article 1(3)




Article 1(3), first indent


Article 1(3)




Article 1(3), second indent


Article 1(3)




Article 1(3), third indent


—




Article 1(3), last wording


Article 1(3)




Article 1(4)


Article 1(4)




Article 1(5)


Article 1(5)




Article 1(6), introductory wording


Article 1(6), introductory wording




Article 1(6), first indent


Article 1(6)(a)




Article 1(6), second indent


Article 1(6)(b)




Article 2(1), introductory wording


Article 2(1), introductory wording




Article 2(1)(a), (b) and (c)


Article 2(1)(a), (b) and (c)




Article 2(1)(d)


—




Article 2(1)(e)


Article 2(1)(d)




Article 2(1)(f)


Article 2(1)(e)




Article 2(1)(g)


Article 2(1)(f)




Article 2(1)(h)


Article 2(1)(g)




Article 2(2), introductory wording


Article 2(2), introductory wording




Article 2(2)(a), (b) and (c)


Article 2(2)(a), (b) and (c)




Article 2(2)(d), introductory wording


Article 2(2)(d), introductory wording




Article 2(2)(d), first indent


Article 2(2)(d)(i)




Article 2(2)(d), second indent


Article 2(2)(d)(ii)




Article 2(2)(d), third indent


Article 2(2)(d)(iii)




Article 2(2)(d), fourth indent


Article 2(2)(d)(iv)




Article 2(2)(e) to (o)


Article 2(2)(e) to (o)




Article 3(1), first subparagraph, introductory wording


Article 3(1), first subparagraph, introductory wording




Article 3(1), first subparagraph, first indent


Article 3(1), first subparagraph, point (a)




Article 3(1), first subparagraph, second indent


Article 3(1), first subparagraph, point (b)




Article 3(1), first subparagraph, third indent


Article 3(1), first subparagraph, point (c)




Article 3(1), second and third subparagraphs


Article 3(1), second and third subparagraphs




Article 3(2), introductory wording


Article 3(2), introductory wording




Article 3(2), first indent


Article 3(2)(a)




Article 3(2), second indent


—




Article 3(2), third indent


Article 3(2)(b)




Article 3(2), fourth indent


—




Article 3(2), fifth indent


—




Article 3(2), sixth indent


—




Article 3(2), last wording


Article 3(2), introductory wording




Article 3(3)


Article 3(3)




Article 4


Article 4




Article 5(1)


Article 5(1)




Article 5(2), first introductory wording


Article 5(2), introductory wording




Article 5(2), second introductory wording


Article 5(2), introductory wording




Article 5(2), first indent


Article 5(2)(a)




Article 5(2), second indent


Article 5(2)(b)




Article 5(2), third indent


Article 5(2)(c)




Article 5(3), (4) and (5)


Article 5(3), (4) and (5)




Article 6(1) and (2)


Article 6(1) and (2)




Article 6(3), introductory wording


Article 6(3), introductory wording




Article 6(3), first indent, first part


Article 6(3), introductory wording




Article 6(3), first indent, second part


Article 6(3), first indent




Article 6(3), second indent


Article 6(3), second indent




Article 6(3), third indent


Article 6(3), third indent




Article 6(4)


Article 6(4)




Article 7


Article 7




Article 8(1) and (2)


Article 8(1) and (2)




Article 8(3), introductory wording


Article 8(3), introductory wording




Article 8(3), first indent


Article 8(3)(a)




Article 8(3), second indent


Article 8(3)(b)




Article 8(3), third indent


Article 8(3)(c)




Article 8(4)


Article 8(4)




Article 9, point 1, introductory wording


Article 9(1), first subparagraph, introductory wording




Article 9, point 1.1, introductory wording


Article 9(1), first subparagraph, point (a), introductory wording




Article 9, point 1.1, first indent


Article 9(1), first subparagraph, point (a)(i)




Article 9, point 1.1, second indent


Article 9(1), first subparagraph, point (a)(ii)




Article 9, point 1.1, third indent


Article 9(1), first subparagraph, point (a)(iii)




Article 9, point 1.1, fourth indent


Article 9(1), first subparagraph, point (a)(iv)




Article 9, point 1.2, introductory wording


Article 9(1), first subparagraph, point (b), introductory wording




Article 9, point 1.2, first indent


Article 9(1), first subparagraph, point (b)(i)




Article 9, point 1.2, second indent


Article 9(1), first subparagraph, point (b)(ii)




Article 9, point 1.3, first subparagraph, introductory wording


Article 9(1), first subparagraph, point (c), introductory wording




Article 9, point 1.3, first subparagraph, first indent


Article 9(1), first subparagraph, point (c)(i)




Article 9, point 1.3, first subparagraph, second indent


Article 9(1), first subparagraph, point (c)(ii)




Article 9, point 1.3, second subparagraph


Article 9(1), second subparagraph




Article 9(2)


Article 9(2)




Article 10, point 1.1, introductory wording


Article 10(1), introductory wording




Article 10, point 1.1(a)


Article 10(1)(a)




Article 10, point 1.1(b)


Article 10(1)(b)




Article 10, point 1.2


Article 10(2)




Article 10, point 2, introductory wording


Article 10(3), introductory wording




Article 10, point 2.1


Article 10(3)(a)




Article 10, point 2.2


Article 10(3)(b)




Article 10, point 2.3, introductory wording


Article 10(3)(c), introductory wording




Article 10, point 2.3.1


Article 10(3)(c)(i)




Article 10, point 2.3.2


Article 10(3)(c)(ii)




Article 10, point 2.3.3, first subparagraph, introductory wording


Article 10(3)(c)(iii), first subparagraph, introductory wording




Article 10, point 2.3.3, first subparagraph, first indent


Article 10(3)(c)(iii), first subparagraph, first indent




Article 10, point 2.3.3, first subparagraph, second indent


Article 10(3)(c)(iii), first subparagraph, second indent




Article 10, point 2.3.3, first subparagraph, third indent


Article 10(3)(c)(iii), first subparagraph, third indent




Article 10, point 2.3.3, first subparagraph, fourth indent


Article 10(3)(c)(iii), first subparagraph, fourth indent




Article 10, point 2.3.3, first subparagraph, fifth indent


Article 10(3)(c)(iii), first subparagraph, fifth indent




Article 10, point 2.3.3, first subparagraph, sixth indent


Article 10(3)(c)(iii), first subparagraph, sixth indent




Article 10, point 2.3.3, first subparagraph, last wording


Article 10(3)(c)(iii), first subparagraph, introductory wording




Article 10, point 2.3.3, second subparagraph


Article 10(3)(c)(iii), second subparagraph




Article 10, point 2.3.4, introductory wording


Article 10(3)(c)(iv), introductory wording




Article 10, point 2.3.4, first indent


Article 10(3)(c)(iv), first indent




Article 10, point 2.3.4, second indent


Article 10(3)(c)(iv), second indent




Article 10, point 2.3.4, third indent


Article 10(3)(c)(iv), third indent




Article 10, point 2.3.4, fourth indent


Article 10(3)(c)(iv), fourth indent




Article 10, point 2.3.4, fifth indent


Article 10(3)(c)(iv), fifth indent




Article 10, point 2.3.4, sixth indent


Article 10(3)(c)(iv), sixth indent




Article 10, point 2.3.4, seventh indent


Article 10(3)(c)(iv), seventh indent




Article 10, point 2.3.4, last wording


Article 10(3)(c)(iv), introductory wording




Article 10, point 2.3.5


Article 10(3)(c)(v)




Article 10, point 2.4, first subparagraph


Article 10(3)(d), first subparagraph




Article 10, point 2.4, second subparagraph, introductory wording


Article 10(3)(d), second subparagraph, introductory wording




Article 10, point 2.4, second subparagraph, first indent


Article 10(3)(d), second subparagraph, point (i)




Article 10, point 2.4, second subparagraph, second indent


Article 10(3)(d), second subparagraph, point (ii)




Article 10, point 2.4, second subparagraph, third indent


Article 10(3)(d), second subparagraph, point (iii)




Article 10, point 2.4, second subparagraph, fourth indent


Article 10(3)(d), second subparagraph, point (iv)




Article 10, point 2.4, third subparagraph


Article 10(3)(d), third subparagraph




Article 10, point 2.5


Article 10(3)(e)




Article 10, point 2.6


Article 10(3)(f)




Article 10, point 2.7


Article 10(3)(g)




Article 10, point 3


Article 10(4)




Article 10, point 4, introductory wording


Article 10(5), introductory wording




Article 10, point 4, first indent


Article 10(5)(a)




Article 10, point 4, second indent


Article 10(5)(b)




Article 10, point 5


Article 10(6)




Article 11(1) to (5)


Article 11(1) to (5)




Article 11(6), introductory wording


Article 11(6), introductory wording




Article 11(6)(a)


Article 11(6)(a)




Article 11(6)(b), first subparagraph, introductory wording


Article 11(6)(b), first subparagraph, introductory wording




Article 11(6)(b), first subparagraph, first indent


Article 11(6)(b), first subparagraph, point (i)




Article 11(6)(b), first subparagraph, second indent


Article 11(6)(b), first subparagraph, point (ii)




Article 11(6)(b), second subparagraph


Article 11(6)(b), second subparagraph




Articles 12 and 13


Articles 12 and 13




Article 15


Article 14, first to fifth paragraphs




—


Article 14, sixth paragraph




Article 16


Article 15




Article 17


Article 16




Article 18


Article 17




Article 19


Article 18




Article 20


Article 19




Article 20a(1) and (2)


Article 21




Article 20a(3)


—




—


Article 20




—


Article 22




Article 21


—




Article 22


—




Article 23


Article 23




Article 24


Article 24




Annex I–VII


Annex I–VII




Annex VIII


—




Annex IX


—




—


Annex VIII




—


Annex IX