The Executive Order On Classification, Packaging, Labelling, Sale And Storage Of Chemical Substances And Products

Original Language Title: Bekendtgørelse om klassificering, emballering, mærkning, salg og opbevaring af kemiske stoffer og produkter

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Table of Contents

Chapter 1 Scope and so on

Chapter 2 Classification

Chapter 3 Packaging and marking

Chapter 4 Sales of very toxic and toxic substances and products

Chapter 5 Storage and theft notification

Chapter 6 Willing marketing.

Chapter 7 The authorities.

Chapter 8 Punishment

Chapter 9 Entry into force into force

Appendix 1

Appendix 2

Appendix 3

Appendix 4

Appendix 5

Appendix 6

Appendix 7

Appendix 8

Appendix 9

Appendix 10

Appendix 11

Appendix 12

Appendix 13

Announcement of classification, packaging, marking, sale and storage of chemical substances and products 1)

Purline 3, paragraph 3. Three, section 6, section 8, paragraph 8. Paragraph 1, section 10, paragraph 10. 4, section 20, section 22, paragraph 22. 2 and 3, section 22a, § 22b, section 23, section 24, paragraph 24. 4 and 5, section 25 (3). 2 and 4, section 26, section 27 (4). 2, section 30, section 42, § 42 a, § 45 (3). Paragraph 1, section 46, paragraph. One and two, section 47, section 59, section. 4-6, and section 60 of the law on chemical substances and products, cf. Law Order no. 878 of 26. June 2010 shall be determined :

Chapter 1

Scope and so on

§ 1. This notice includes chemical substances and products.

Paragraph 2. For the purposes of chemical substances, substances and their compounds shall mean that they appear naturally or industrially produced, containing such additives as necessary to maintain the stability of the substance and such impurities, which are required to maintain the stability of the substance ; resulting from the manufacturing process, other than solvents which may be separated without affecting the stability of the substance or the composition of the substance.

Paragraph 3. For the purposes of chemical products, solutions are understood as well as solid, liquid and air formige mixtures of two or more chemical substances.

Paragraph 4. Member States shall mean the countries that are a member of the European Union and Iceland, Liechtenstein and Norway.

Paragraph 5. Regulation (EC) No 2 of the Regulation (EC) No, 1272/2008 of 16. In December 2008, on the classification, labelling and packaging of substances and mixtures and amending and repealing Directive 67 /548/EEC and 1999 /45/EC and amending Regulation (EC) No 149/EC and amending Regulation (EC) No (EC) No (EC) No (EC) No 1907/2006.

Paragraph 6. The requirements of the environmental legislation on chemical substances and products and on notification to the substances and materials register and the rules on safety data sheets shall not be affected by the rules of this notice.

§ 2. The notice shall not apply to radioactive substances as defined in Directive 80 /836/EEC.

Paragraph 2. Chapters 3, 4, 5 and 6 shall not apply to chemical products in the form of munitions and explosive materials placed on the market in order to produce a concrete impact on the explosion or by pyrotechnious road.

Paragraph 3. The notice shall not apply to the following chemical products in use, intended for the final user :

1) Medicinal products for human use and veterinary medicinal products.

2) Foodstuffs.

3) Feedingstuffs.

4) Cosmetic products, cf. The Ministry of the Environment, at any time, shall apply.

5) Fighting measures to be approved under the Chapter 7 of the law, unless otherwise provided by the Ministry of the Ministry of the Ministry of the Environment, in accordance with the rules applicable to it, cf. however, section 5 (5), 5.

6) Mixtures of substances in the form of waste.

7) Products containing radioactive substances as defined in Directive 80 /836/Euratom.

8) Such medical equipment which is intended to be placed in or used directly in contact with the human body, provided that Community legislation lays down rules on the classification and labelling of dangerous products that ensure the same, the level of information and protection provided for by this notice.

Paragraph 4. The notice shall not apply in the context of

1) the transport of chemical products,

2) chemical products produced abroad, insofar as they are not the subject of any treatment or processing carried out, but only through the country as a transit or storage area as such ; or

3) export of chemical substances and products, with the exception of section 6 on the obligation to provide information and section 36 (3). Paragraph 1 and 3, and section 38 (3). 1 on storage, which also applies to exports.

§ 3. The applicable import rules for imports shall apply to imports into the market and to import into use in their own business.

Chapter 2

Classification

§ 4. Any producer or importer of a chemical or product must, prior to sale or import thereof, obtain such information on the characteristics of the substance or the product and the effects of the product, whether or not the substance or product is to be assessed ; hazardous, cf. § 5.

Paragraph 2. Chemical substances included in the list of hazardous substances shall be classified in accordance with the entry of the substance in the list and shall not be classified for these grasses and splits. However, where the substance also falls within the scope of one or more classes or divisions not covered by the entry, the substance shall be classified in accordance with it.

§ 5. Chemical substances included in the list of hazardous substances, and chemical substances and products which satisfy the criteria laid down in Annex 1 are classified as dangerous.

Paragraph 2. Dangerous chemical substances and products are classified in one or more of the following ads : explosive, oxidising, highly flammable, highly flammable, flammable, highly toxic, harmful, corrosive, irritant, sensitising, carcinogenic, mutagen, reproductive or environmentally hazardous.

Paragraph 3. Dangerous chemical substances and products are assigned the indication of danger symbol and indication of danger, cf. Annex 3, risk phrases (R-phrases), cf. Annex 4, and Safety Notices (S-phrases), cf. Annex 5.

Paragraph 4. Loading in the classes and award of danger symbols, indications of danger, R-phrases and S-phrases, cf. paragraph 2 and 3 shall be carried out in accordance with the criteria set out in Annex 1 or to substances included in the list of hazardous substances, in accordance with this, cf. however, section 4 (4), TWO, TWO. Period.

Paragraph 5. Combating agents is classified in class ads, assigned hazard symbols and indications of danger, as well as risk phrases and safety regulations in accordance with the rules set out in Annexes 1 to 5. In the case of risk phrases and safety requirements for plant protection products, the award shall also be granted in accordance with Annexes 4 and 5 of Council Directive 91 /414/EEC of 15. July 1991 on plant protection products.

§ 6. Any producer or importer who have sold or imported a chemical product which a producer in a Member State wishes to use as a component of another chemically product shall, on a reasoned request from the second producer, shall, as soon as they are subject to a reasoned request from the other producer, be able to provide him with all the information on the dangerous chemical substances present in the product, which are necessary for the other manufacturer to assess whether or not to classify the product in accordance with. § 5.

Paragraph 2. Any manufacturer or importer who have sold or imported a chemical containing an individual component, an unurity or an additive classified as dangerous and which another producer in a Member State wishes to use as a member component of a chemical product, after reasoned request from the second manufacturer, to provide him with all the information on the substance, including the individual components, impurities or additives necessary for the purposes of : the second manufacturer can assess whether or not to classify his product, cf. § 5.

§ 7. Any manufacturer or importer who has classified a chemical substance as a CMR substance must, where the substance is placed on the market, communicate the name of the Eco-Management Committee, cf. Section 15 (3). 1, as well as the classification of the substance, whether marketing takes place as pure substance or as a component of a chemical product. This does not apply to substances that are on the list of hazardous substances.

Paragraph 2. In addition to the information referred to in paragraph 1, 1, any producer or importer shall, as quickly as possible, submit a written summary of all relevant information to the Environmental Management Board. The summary shall include a bibliography with all relevant references and any other non-published relevant data. Where the manufacturer or importer comes into possession of new data on a substance relevant to the classification as a carcinogen, mutagen or reproduction, these shall be transmitted as soon as possible to the EPA. This is true whether the new data relates to a substance that is included in the list of hazardous substances, or a substance that is not.

Chapter 3

Packaging and marking

§ 8. Chemical products covered by one or more of the rules laid down in this Chapter may be sold only if they are packaged and marked in accordance with those rules.

§ 9. For import, cf.. Section 3, of the chemical products referred to in section 8, the importer shall immediately after the removal of the warehouse of packaged packaged packaged and mark the rules referred to in § 8.

Paragraph 2. Chemical products, as referred to in section 8, which are not taken from storage, are transported directly from foreign to the importer ' s Danish customer, must be packaged and labelled in accordance with the rules referred to in Section 8 before handing out to the customer.

§ 10. Packagings containing dangerous chemical products must meet the following requirements :

1) The packaging must be such designed and constructed that the content cannot be inadvertentionally unintentionally.

2) The material on which the packaging and the closure have been manufactured must not be able to be attacked by the content or could enter into dangerous relations with this.

3) The packaging and closure must in all parts be so solid and powerful that it is not possible to loosen up, and must be able to withstand the treatment for which the experience is exposed.

4) Packaging of closure device enabling the packaging to be closed again shall be so constructed as to enable the packaging to be closed on several occasions without the inadvertenance of the content.

5) The packaging must be designed in such a way that whole or partial emptying may be carried out in a responsible manner.

Paragraph 2. Packaging meets the requirements of paragraph 1. 1, no. 1, 2 and 3, if it meets the requirements for the transport of dangerous goods by rail, road, inland waterway, sea or air.

§ 11. Packages which are sold a detail to the general public and contain chemical products to be labelled with the indication of danger very toxic, Toxic or Ætending, shall be provided with child-proof closure.

Paragraph 2. The same applies to packaging, which is sold a detail to the general public and which contains :

1) liquid chemical products, which involve an aspirage and classified health damage to R65 in accordance with section 3.2.1.3 of Annex 1.

2) chemical products containing methanol in a concentration of 3% or more ; or

3) chemical products containing dichloromethane in a concentration of 1% or more.

Paragraph 3. The people in paragraph 3. 2, no. 1, the said products do not have to be equipped with child-proof closure when they are sold in packaging under pressure or equipped with a sealed spray device.

Paragraph 4. Child-proof closures shall comply with the requirements laid down in Annex 6.

§ 12. Packings which are sold a detail to the public and containing chemical products to be labelled, Highly flammable, Highly flammable, Meget giftig, Toxic, Ætending or Healthcare, must be provided with a feel-able warning labels.

Paragraph 2. The provision in paragraph 1 shall be Paragraph 1 shall not apply to aerosols that contain only chemical products, which must be labelled as highly flammable or highly flammable.

Paragraph 3. Sensitive warnings must comply with the requirements set out in Annex 7.

§ 13. Packagings containing dangerous chemical products, or chemical products covered by the rules in paragraph 2 of Annex 2, must be provided with a label to contain :

1) the name or trade name of the product ;

2) in the case of products sold in detail to the public : the nominal quantity nominal (nominal mass or nominal volume),

3) the name and company address, including telephone number, of a person established in a Member State established by a natural or legal person responsible for placing the market on the market,

4) chemical-chemical name in accordance with the rules laid down in section 15 for the constituents of the content referred to in section 14 ;

5) in the case of products covered by Annex 2, Section 2 : labelling in accordance with the provisions of point 2 of Annex 2, and

6) for dangerous products : the product ' s labelling in accordance with the rules set out in Annex 2 (1),

a) indications of danger and danger symbols,

b) R-phrases and

c) S-phrases.

§ 14. On the label of chemical products to be classified as highly toxic, toxic or harmful to health, the substances classified as highly toxic, toxic or harmful to health, and which occur in a concentration are to be classified ; there is greater than or equal to the lower concentration limit of the substance to classification as harmful to health, cf. Annex 1, point 3.3.1.

Paragraph 2. On the label of chemical products to be classified as corrosive, the content substances are declared as corrosive and which occur in a concentration that is greater than or equal to the lower concentration limit of the substance ; classification as irritant, cf. Annex 1, 3.3.4.

Paragraph 3. On the label for chemical products, the content (s) of the substance (s) which give rise to the classification of the product in one or more of the following categories shall be indicated :

1) Carcinogenic, Category 1, 2, or 3.

2) Mutagen, category 1, 2, or 3.

3) Reproductive Toxic, category 1, 2 or 3.

4) Meget giftig, toxic or harmful on the basis of non-lethal effects after a single exposure.

5) Toxic or harmful on the basis of serious adverse effects after repeated or prolonged exposure.

6) Sensitizing.

Paragraph 4. On the label of concentrated products intended for the perfume industry, it is, regardless of whether the product contains more than one sensitizing substance, to indicate the substance that is essentially the cause of the danger of oversensitivity.

§ 15. When the name of a chemical substance according to the rules in section 13, 4, and section 14 must be indicated on the label for a chemical product, the internationally recognised nomenclature must be used, preferably in the name used in the EINECS (European inventory of chemical substances marketed by the EINECS). If the substance is included in the list of hazardous substances, the description given in this list shall be used.

Paragraph 2. The person responsible for the placing on the market of the chemical product may, if he is able to demonstrate that the indication of the chemical identity of a substance on the label would damage the protection of information about his intellectual property, get permission to refer to the substance in question, either by a name of the substance of which the main functional chemical groups appear or in an alternative designation. It is a prerequisite for the fact that the substance is classified only as harmful to R20, R21, R22 or R65.

Paragraph 3. Applications for authorisation, cf. paragraph 2, must be submitted to the Environmental Management Board. The application shall contain the information specified in Annex 8 (1). An application for the confidentiality of the same substance in several products is sufficient, if :

1) they contain the same dangerous substances in approximately the same concentrations ;

2) are classified and labelled in the same way and

3) the products are used in the same way.

Paragraph 4. The Environmental Management Board shall not be able to accommodate the application if the application of the provisions of paragraph 1 2 mentioned substances have been laid down for exposure to a Community limit value. The environmental management board shall ensure that the alternative designation in any case provides sufficient information to allow the product to be handled risk-based.

Paragraph 5. The alternative designation of the label, cf. paragraph 2, must be the same as the one specified in item 3 of the safety data sheet. The alternative designation may be granted in accordance with the instructions given in Annex 8 (2), with the corresponding text list.

Paragraph 6. Application to the Environmental Management Board pursuant to paragraph 1. 3 may be omitted if an equivalent application has already been granted by the competent authorities of another Member State, provided that the person responsible for placing it on the market shall forward a copy of the authorisation to the Environmental Management Board.

§ 16. The information required in section 13 must be accompanied by a label (the label), which may constitute part of a larger label if the conditions set out in paragraph 1 are concerned. Two is met.

Paragraph 2. The text of the area label must be drawn up in Danish and must, for example, in the case of framing, separate itself clearly from other information, including labelling in other languages, cf. Article 42 (2). 3.

Paragraph 3. The field label must have the following format, cf. however, section 19 :

1) If the space of the packaging is 3 litres or less, the format must be at least a 52x74 mm minimum.

2) Where the ruby package is 3 litres and less than or equal to 50 litres, the format must be at least 74x105 mm.

3) If the wrapper ' s space hold is more than 50 litres and less than or equal to 500 litres, the format of the format must be at least 105x148.

4) If the size of the packaging is more than 500 litres, the format, if possible, must be at least 148x1210.

Paragraph 4. The area of the area of the area of the area of the area may be used only for the information in section 13 for the information and any additional hygiene or safety requirements.

Paragraph 5. Each danger symbol shall record at least one-tenth of the hazard surface of the hazard. It must not be less than 1 cm 2 .

Paragraph 6. The characteristics of the label or in the cases referred to in paragraph 20 shall ensure that the symbol of danger and its orangeal yellow background are clearly stated. The text must distinguish itself from the background and be of sufficient size and must be provided with sufficient space to allow it to be easily legible and it must not be easily expulated.

§ 17. The field label shall be attached to the packaging so that the text can be read horizontally, when the packaging is stored in the usual manner. The label shall be attached to the packaging all of its surface to the packaging immediately containing the chemical product and in such a way as to keep it on the packaging until the content is exhausted.

Paragraph 2. If the product is sold in double sales packaging, the parts of the packaging shall bear the information required in section 13, cf. however, section 21, no. 1.

§ 18. If the content of the package is 125 ml or less is the labelling of R and S-sentences is not required if the chemical product is classified as dangerous for the environment at the danger symbol N, highly flammable, oxidising or irritant to R36, R37 or R38.

Paragraph 2. If the contents of the package are 125 ml or less, the labelling of S-phrases is not required if the chemical product is classified as flammable or environmentally hazardous without the danger symbol " N.

§ 19. Labelling may be given on a separate label, provided that the packaging is of such a limited size, that it is not possible to use a label of the size 52 x 74 mm and the text cannot be clearly expressed in a small label. Divorced mark may also be used where the packaging is such that it is not appropriate to use a label. The special label shall also meet the required format, text and colour requirements, so that it remains on the packaging until such time as the content is exhausted. However, a note of S-phrases may be attached to the wrapping if it is not feasible in practical terms to make them on the label or the packaging itself.

Paragraph 2. Provided that a smaller label is used, cf. paragraph 1, the symbol of danger shall not be less than 1 cm ; 2 .

20. A label is not required when the particulars are clearly indicated on the packaging itself in accordance with the rules in section 13-19.

§ 21. The requirements of this notice as regards labelling shall be deemed to be fulfilled ;

1) a packaging transforms one or more internal packaging, marked in accordance with the notice, provided that the outer packaging is at least marked in accordance with the international / national provisions on the transport of : dangerous substances and products, or

2) where a single package is used, where this is labelled in accordance with international / national provisions on the transport of dangerous substances and products, as well as in accordance with section 13 (s). 1, 3, 4, 5 and 6 (b) and (c) and Section 16.

§ 22. Mobile gas containers are covered by the rule in section 21, nr. 2. For gas containers with a water capacity of 150 I or less, the format and design of the label may be the format and design rather than following the rules in section 16 (3). 1, 3 and 4, section 17 (4). 1, as well as 20. According to the provisions of ISO standard ISO / DP7225 (1994-Release) concerning gas cylinders-caution-labelling. In the case of chemical products, the label may in the product or trade name of the product, provided that the names of the dangerous substances included in the product are clearly and indelibly marked on the body of the gas container.

Paragraph 2. Propane, butane and LPG (devved crude oil gases) are included in the list of hazardous substances. Regardless of the fact that they are classified under section 5, it is not a requirement that chemical products containing these substances are labelled for the effects on human health when marketed as fuels that are only closed to incineration in closed, restocking gas containers or in non-restocking gas containers which comply with EN 417 (version of September 1992 concerning one-time bottles for LPG, with or without the portable apparatus ; design, control, testing and marking). Similarly, for the smell of propane, butane and LPG, regardless of the fact that these products are to be classified according to section 5.

Paragraph 3. The producer or the importers shall, if they are in accordance with paragraph 1. 2 mentioned products are not labelled for effects on human health, communicate to professional users all the information which may otherwise appear on the label in the safety data sheet. In the case of sale of a detail to the public, on the label or in a supplier ' s instructions, sufficient information shall be provided to the user to take the necessary measures to protect health and safety.

-23. Chemical products in the form of leagings and chemical products consisting of polymers or elastomers do not need a label according to the rules of section 13-19, even if they are to be classified as dangerous under Clause 5 if they do not constitute any danger to the aquatic environment or to health by inhalation, ingestion or skin contact in the form in which they are placed on the market.

Paragraph 2. The producer or importer shall, if a product in accordance with the rule set out in paragraph 1, 1 do not appear to be labelled, to inform the user of the product all the information which would otherwise have been indicated on the label of the safety data sheet.

Chapter 4

Sales of very toxic and toxic substances and products

§ 24. The rules laid down in this Chapter, as well as in paragraph 36, paragraph 1, 3 and 4, and section 37 on very toxic and toxic substances and products, shall apply to all substances and products to be assigned the indication of danger Very toxic or toxic, and chemical substances and products to be classified as carcinogenic, mutagenic or toxic to reproduction in categories 1 and 2 and assigned the symbol " T " in accordance with this notice and under the Regulation shall be classified as acute toxic in categories 1, 2 or 3 (Acute Tox. 1, 2 or 3), or as a specific target organ toxic in category 1 (STOT SE 1) or as a carcinogen, mutagenic or toxic to reproduction in category 1 A or 1 B (Carc. 1A or 1B, Muta 1A, or 1B, or Repr, 1A, or 1B).

§ 25. Very toxic and toxic substances and products may only be sold to purchasers who emits a requisition in accordance with the rules in section 30-34. However, this does not apply to sales to the undertakings, institutions and persons referred to in Section 26.

Paragraph 2. Very toxic and toxic substances and products must not be sold to people under the age of 18, or are left to persons who are presumed to cause damage to themselves or to their surroundings.

SECTION 26. Very toxic and toxic substances and products must be sold without requisition ;

1) the following institutions, establishments, etc.

a) hospitals,

b) scientific and technical laboratories and institutions operated by the State, the regions or the municipalities ;

c) technological services approved by the Secretary of State for Science, Technology and Development ;

d) laboratories and establishments accredited, cf. The rules of the Ministry of Economic and Business Affairs,

(e) establishments which, under the pharmaceutical bill, have the permission of the Health Board to manufacture and negotiate medicinal products, including pharmacies,

(f) higher educational establishments, technical, high school schools and student courses, hf-courses, teaching seminars, technical schools, trade schools and social and health schools ;

g) Doctors, dentists, veterinarians,

2) establishments producing very toxic and toxic substances and products, and other establishments which use such substances and products as raw materials or ancillants when these undertakings have notified the Board of Work,

3) undertakings which sell very toxic and toxic substances and products for further negotiation or to the products referred to in paragraph 1. 1 and 2 of the establishments, institutions and persons referred to in the Committee on the Environment, Public Health and Food Safety and the Agency for the Environment,

4) Resellers other than those in no. 3, however, only in the case of substances and products covered by a permit granted under section 28.

Paragraph 2. The notification referred to in paragraph 1. 1, no. 2 and 3 shall be submitted on a form which may be retrieved by the Internet or the Environmental Management website on the Internet. The form shall be reproduced in Annex 9. This communication is valid for 3 years.

Paragraph 3. The notification referred to in paragraph 1. 1, no. 2 and 3 shall contain information on the nature and scope of the substances or products concerned, as well as the quantities produced and sold.

§ 27. Anyone who sells very toxic and toxic substances and products has a duty to ensure that the buyer is entitled to purchase the substances or products concerned.

§ 28. Only pharmacies and negotiators authorised by the Environmental Management Board must sell very toxic and toxic substances and products to other companies, institutions and people than they mentioned in section 26.

Paragraph 2. Therefore, in exceptional cases where the inspection or surveillance of the safe use of poisons is therefore authorized, a permit as referred to in paragraph 1. 1 is given to a association or similar, whose members are engaged in the association of the association of the association, even though the association itself does not act as a negotiator. In this case, the Union shall ensure that the Environmental Management Board at all times is in possession of an up-to-date list of the negotiators who are not authorised to sell the poison to the members of the association, without the permission of the association. The Environmental Management Board may, in the authorisation, lay down procedures, including time limits and requirements for the collection and retention of requisitions and the other documentation of individual resellers.

Paragraph 3. The one authorized in accordance with paragraph 1. Paragraph 1 (1). 2 or the corresponding previously applicable rules shall pay a fee of 1000 DKK every two years. to the Environmental Management Board. The fee is due to be paid 1. January, and must be paid before 1. Feb. The fee is for the first time in the first place. January of the year after the authorisation has been granted.

§ 29. Very toxic and toxic substances and products may be imported only by the undertakings, institutions and persons referred to in paragraph 26.

-$30. The one in section 25, paragraph 1. 1, mentioned requisition is issued by the police or picked up on the Internet's Central Web site. The request is rendered in Appendix 10.

Paragraph 2. The requisition must be dated and signed by the requestor personally. It must contain

1) information on the designation, quantity and use of the substance, or of the product,

2) the name, position and address of the requestor, and

3) declaration by the requestor that the person concerned only to use the substance or product as specified, store it carefully and not assign it to others.

Paragraph 3. The request is valid only for a single sale, even if only a portion of the quantity specified is sold.

§ 31. The requisition must before the sale have been provided with the police's endorsement of the fact that the police allow for sale to the specified purpose.

Paragraph 2. As a condition for the requisition of the requisition, the police may require that the requestor documents to have appropriate knowledge of the use of the substance or product and to have the possibility of taking the necessary safety measures.

§ 32. The request must not be endorsed if the police estimate that the specified purpose can be met in a fair manner by means of less hazardous means. In addition, the person who is under 18 shall be refused persons under the age of 18, or which may cause injury to be inflited on themselves or their surroundings.

§ 33. Very toxic and toxic utility reagents ordered on a rederis ' requisition to a particular ship in the shipping fleet for use by the chief of machinery or the master at the test, treatment and maintenance of technical installations ; etc., can be sold without the police endorsement of the requisition.

§ 34. Very toxic and toxic, artistic use of artistic use, can be sold without the police's endorsement of the requisition.

Paragraph 2. The people in paragraph 3. Paragraph 1 shall be exempt from the special provisions relating to the storage of toxins in section 36 (3). Two and three.

$35. The dispatched requisitions must be provided with serial numbers, the date of sale and the name of the expedient, and then stored in the numbering for five years.

Paragraph 2. If a business is sold, they must retain requisitions of props to the police. Where the new holder of the business achieves the authorisation of the Environment Board for sale of very toxic and toxic substances and products, a detail, cf. Article 28, however, must continue to be kept in the business.

Paragraph 3. For the record, they shall in section 26 (4). 1, no. 1-4, establishments, establishments and persons of sale of very toxic and toxic substances and products shall keep a list of products or records of the name, position and address of the consignon, the quantity of the substance or the product, the quantity and the product of the product ; use and date of sale. However, a specified printout of the establishment ' s regular accounts shall be sufficient if the printout can be approved by the Environmental Management Board. When selling to requisition is the retention of the requisitions of the requisitions sufficient, cf. paragraph 1.

Paragraph 4. You in section 26, paragraph. 1, no. However, the establishments, institutions and persons referred to above shall not be subject to the list or directory of the sale of very toxic and toxic substances and products.

Chapter 5

Storage and theft notification

§ 36. Very toxic and toxic substances and products, cf. Section 24 must be kept in a safe place, under lock, inaccessible to children, and not with or near food, feedingstuffs, pharmaceuticals, etc.

Paragraph 2. Entities and establishments storing very toxic and toxic substances and products and substances and products which are to be classified as acute toxic in categories 1, 2 or 3 (Acute Tox. 1, 2 or 3) or as specific, the target organ toxic in category 1 (STOT SE 1) in a total quantity of more than 125 ml and to which more than five persons are leaving shall appoint one or more persons who, on behalf of the establishment or the institution, ensure that the storage of the substances in question is concerned ; and products shall be carried out in accordance with paragraph 1. 1, including that they do not have access to them.

Paragraph 3. The traders referred to in section 28 shall also keep very toxic and toxic substances and products in separate and sealed closet or spaces that are clearly marked with a warning board, as indicated in Annex 11. In such a toxic or toxic waste must not be placed other than very toxic and toxic substances and products, including very toxic and toxic pesticides.

Paragraph 4. At the section, section 26, paragraph. 1, no. 1-3 companies, institutions and persons mentioned shall all be doors to create rooms, premises and so on which are stored very toxic and toxic substances and products, in addition to a warning board, as specified in Annex 11.

§ 37. Very toxic and toxic substances and products, cf. Section 24 may not be kept in such packaging, which may give rise to confusion of the content.

Paragraph 2. The establishments, institutions and persons referred to in Section 26 shall be stored in the original packaging or in another similar packaging, marked with the name of the substance or the product ' s name, in section 26, indications of danger, danger symbols, and R-and S-phrases in accordance with section 13, nr. 1 and 4 6, section 16 or, as provided for in the regulation, are labelled with the product indicators, additional information, danger pictograms, signalling, danger and safety phrases in accordance with Article 17 (1) of the Regulation. Article 18 (1). Articles 2 and 3, Articles 19 to 22 and Article 25.

Paragraph 3. Notwithstanding paragraph 1 2 may very toxic and toxic substances and products of the products referred to in section 26 (3). 1, no. 2, mentioned establishments, stored in production facilities or systems, after notification of this is given to the Board of Work. Manufacturing installations or systems must be marked in accordance with the Safety signalling and signalling rules of the Work in the System. The notification shall be lodged on the one in section 26 (3). 2, mentioned form.

Paragraph 4. In other than the establishments, establishments and persons referred to in Section 26, very toxic and toxic substances and products must be stored in the original packaging.

§ 38. Substances and products to be labelled with the indication of danger Ætsending, Harmful or Local-ripening in accordance with this notice or under the Regulation shall be classified as acute toxic in category 4 (Acute Tox. 4), or Skin rows in category 1A, 1B or 1C (Skin Corr. 1A, 1B, 1C) or huckrotingly in Category 2 (Skin irrit. 2) or as a leading irreversible impact of the Eye in category 1 (Eye Dam. 1) or in category 2 (Eye Irrit. 2), or sensitizing by inhalation of category 1 (Resp. Sens. 1) or sensitising when skin contact is in Category 1 (Skin Sens. 1) or carcinogenic, mutagenic or reproduction in category 2 (Carc. 2, Muta, 2, or Repr. 2) or specifically target organic toxic (STOT RE 2, STOT 2 or STOT 3) or aspirational to be in category 1 (Asp. In all cases, it must be kept in a safe and accessible place, accessible to children, not with or near food, feed, medicinal products and other similar substances.

Paragraph 2. In retailers where customers have direct access, they shall be required to do so in paragraph 1. 1 substances and products not equipped with child-proof closure shall be retained at least 1,50 m. above floor height. Child-proof closures shall be in accordance with Annex 6.

Paragraph 3. The people in paragraph 3. 1 the said substances and products must be stored in the original packaging or in another similar packaging, labelled with the name, danger symbols, danger symbols, and R-and S-phrases in accordance with section 13 (s). 1 and 4 6, section 16 or labelled with the product indicators, additional information, danger pictograms, signalling, signalling, danger and safety phrases in accordance with Article 17 (1) of the Regulation. Article 18 (1). Articles 2 and 3, Articles 19 to 22 and Article 25.

Paragraph 4. Notwithstanding paragraph 1 3 may be able to corrosive substances and products from production establishments in production facilities. Manufacturing installations or systems must be marked in accordance with the Safety signalling and signalling rules of the Work in the System.

§ 39. Environmental hazardous substances and products must be kept in a safe place. They must be stored in the original packaging or in another similar packaging, which is marked with the name, indication of danger, symbol of danger, and R and S phrases in accordance with section 13 (s). Paragraphs 1, 4 to 6, section 16 or labelled with the product indicators, additional information, danger pictograms, signalling, danger and safety phrases in accordance with Article 17 (1) of the Regulation. Article 18 (1). Articles 2 and 3, Articles 19 to 22 and Article 25.

§ 40. Undertakings and institutions submit notification to the police on grounds of probable suspicion of the theft of chemical substances and products which, in accordance with Annex 1 (3), must be classified as highly toxic with R-statement R26, R27 or R28, or as toxic, R-statement R23, R24 or R25 in accordance with this notice or pursuant to the Regulation as acute toxic in category 1 with the Fearpieces of H300, H310 and H330 or as acute toxic in categories 2 or 3 with fares H301, H311, H330, or or H331.

Paragraph 2. Notification, cf.. paragraph 1, the following information shall include :

1) Designation or trade name of the chemical or product.

2) Fares or R-phrases for the chemical or product.

3) For chemical substances, the CAS number of the substance.

4) For chemical products : CAS number of the product classification referred to in the product or in the case of substances which have caused the product classification. paragraph 1.

5) Any other characteristics, such as serial numbers or production numbers.

6) The stolen quantity.

Chapter 6

Willing marketing.

§ 41. A chemical or product must not be sold under circumstances suitable to mislead the users in terms of the use of the substance or the product, or the risk associated with the substance or product.

Paragraph 2. In the case of the placing on the market of a chemical or product, no statement is appropriate to give users the opinion that the substance or product does not pose a risk to humans or the environment. This applies, inter alia, to indications such as unsafe, untoxic, not harmful to health, not subject to compulsory testing, including those tested for.... (for example, allergies), approved, environment and nature and compositions thereof.

Paragraph 3. In the case of the placing on the market of chemical substances and products, the symbols indicated in Annex 3, the R-phrases specified in Annex 4, and those listed in Annex 7 may be used only if this is followed by the rules laid down in Chapter 3. Symbols, statements, and warnings that can be confused with the 1. the period referred to shall not be used.

Paragraph 4. Commitments indicating that a chemical or product does not contain certain substances may only be used if, as appropriate, such substances may be considered as appropriate information for users. In any case, such statements may only be used if the substance or product does not contain other substances having similar or similar fire, health or environmental or undesirable properties such as the substance in which it is indicated not to contain.

§ 42. Chemical products covered by the rules laid down in Chapter 3 shall not have a presentation or designation used for food, animal feed, medicinal products or cosmetics.

Paragraph 2. Chemical products covered by the rules laid down in Chapter 3 and which are sold a detail to the general public must not have a package that is designed or decorated to attract children's active curiosity.

Paragraph 3. Chemical products to be labelled according to the rules laid down in Chapter 3 may not be sold with labels or markings which appear deceptive in relation to the indication of danger or to the extent to which the attention is discharged from this point of origin.

§ 43. Advertising for chemical products referred to in Chapter 3 and which allows a consumer to enter into a contract without first having seen the product's label must refer to the advertisements referred to on the label or the trade label.

Chapter 7

The authorities. Decisions. Dispensation. Klage.

§ 44. Decisions pursuant to this notice shall be taken in accordance with the rules laid down in Articles 52, section 53 and Section 54 (54). 2.

§ 45. The Management Board shall monitor compliance with the rules in the notice and decisions taken pursuant thereto.

§ 46. The Environmental Management Board may, in exceptional cases, allow the rules in the notice to be waisted.

Paragraph 2. The Environmental Management Board may amend the Annex of the Executive Order.

§ 47. Decisions taken by the police on sections 31 and 32 may be made to the Environmental Management Board.

Paragraph 2. The decisions of the environmental management authority may not be brought to the second administrative authority.

Paragraph 3. The people in paragraph 3. 1 the decisions referred to shall include :

1) the date of the expiry date of the appeal ;

2) where the appeal is lodged, cf. § 48, paragraph. 2, and

3) the complaint must be received no later than the expiry of the complaint.

§ 48. For decisions to be clawed, the time limit shall be four weeks from the date of the decision, cf. Section 57 of the law.

Paragraph 2. The appeal shall be lodged with the authority which has taken the decision and shall be forwarded from it to the EPA, together with the material entered into by the judgment of the Committee.

Chapter 8

Punishment

§ 49. Unless higher penalties have been inflited on the other legislation, the penalty shall be punished by fine ;

1) in violation of section 23 (1). 2, section 27, section 35, and section 41-43,

2) fails to classify a chemical or product, after sections 4 and 5, to provide information in accordance with section 6 and 7, or to file a police report after 40,

3) sells a chemical product that is not packaged or labelled after § 8 or imports a chemical product without packaging and marking it in section 9,

4) sell a chemical or product in breach of sections 25 and § 28 (3). 1, or imports a chemical or product in violation of section 29,

5) overrides terms associated with a permit in accordance with section 28 (5). 1, or

6) store a chemical or product in breach of section 36-39.

Paragraph 2. The sentence may rise to prison for two years if the infringement has been committed intentionally or by gross negligence and if there is a breach of the infringement proceedings ;

1) an injury to human or animal life or animal health or, therefore, of danger, or

2) damage to the environment or caused by danger, or

3) obtained or intended to be economically advancuable, including in the case of savings, for the person concerned or others.

Paragraph 3. For violation of section 8, section 9, section 25, section 28 (1). 1, and section 36 to 39 may be imposed on a manufacturer, an importer or an owner or a holder of any debtor's responsibility, unintentionally unintentionally not attributed to this as deliberate or negligent. Such executor liability shall not be subject to the conversion penalty.

Paragraph 4. Where an economic advantage is obtained, this shall be confiscated by the rules of the penal code 9. Chapter, even if there is no violent injury to the environment or to health or to the cause of such infringement. If no confiscation can be taken, special consideration shall be given to this by the measurement of a fine, including any additional fine.

$50. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

Chapter 9

Entry into force into force

§ 51. The announcement shall enter into force on 1. February, 2011, cf. however, paragraph 1 2.

Paragraph 2. The provision in section 36 (3). 2, however, shall not enter into force on 1. April 2011.

Paragraph 3. Publication no. 329 of 16. May 2002 on the classification, packaging, marking, sale and storage of chemical substances and products are hereby repealed.

Ministry of the Environment, the 12th. January, 2011

Karen Ellemann

/ Michel Schilling


Appendix 1

CLASSIFICATION

Content
1.
General Introduction
2.
Classification of fire and explosion risks
2.1.
Introduction
2.2.
Criteria for classification
2.2.1.
Explosive
2.2.2.
Brandnourishing
2.2.2.1.
Comments concerning peroxides
2.2.3.
Highly flammable
2.2.4.
Very flammable.
2.2.5.
Flammable
2.2.6.
Other physico-chemical properties
2.3.
Gas-mixing products (gas mixtures)
2.3.1.
Fire Farliness
2.3.2.
Oxidising properties
3.
Health Hazard Classification
3.1.
Introduction
3.2.
Criteria for classification based on survey data
3.2.1.
Acute lethal effects
3.2.1.1.
Meget giftig
3.2.1.2.
Giftig
3.2.1.3.
Harmful
3.2.2.
Non-lethal, but irreversible effects after a single exposure
3.2.2.1.
Meget giftig
3.2.2.2.
Giftig
3.2.2.3.
Harmful
3.2.3.
Serious adverse effects on repeated or prolonged exposure
3.2.4.
Comments regarding very volatile substances
3.2.5.
Agrating and irritant effects
3.2.5.1.
Ate
3.2.5.2.
Locator
3.2.6.
Sensitizing effects
3.2.6.1.
Sensitivity by inhalation
3.2.6.2.
Sensitivity on skin contact
3.2.6.3.
Immunological contact ticeria (non-oedefect)
3.2.7.
Carcinogens, mutagenic and toxic effects
3.2.7.1.
Carcinogens
3.2.7.2.
Mutagenic substances
3.2.7.3.
Toxic to reproduction
3.2.8.
Other toxicological properties
3.3.
Classification of products based on the classification of the incoming substances
3.3.1.
Acute lethal effects
3.3.2.
Non-lethal, but irreversible effects after a single exposure
3.3.3.
Serious adverse effects on repeated or prolonged exposure
3.3.4.
Agrating and irritant effects
3.3.5.
Sensitizing effects
3.3.6.
Carcinogens, mutagenic and toxic effects
3.3.7.
Other toxicological properties
3.3.8.
Gas-mixing products (gas mixtures)
4.
Environmental Impact Classification
4.1.
Introduction
4.2.
Criteria for classification based on survey data
4.2.1.
Aquatic environment
4.2.2.
Other ecosystems other than the aquatic environment
4.3.
Classification (aquatic environment) of products based on the classification of the incoming substances
4.3.4.
Other ecosystems other than the aquatic environment
4.3.5.
The ozone layer
5.
Safety Phracks Selection
1.
GENERAL INTRODUCTION
Chemical substances and products must be assessed in respect of their quality (classifications), cf. § § 4 and 5. This Annex resides the requirements for this classification. For the purposes of this Annex, chemical substances and products of this Annex are also understood to be the plant protection products and biocidal products, unless otherwise stated in the text.
The purpose of the classification of chemical substances and products is to identify all non-resident physico-chemical, toxicological and ecotoxicological properties which may give rise to risks during normal handling or use. It takes account of all the possible dangers which may be exposed to normal handling and use of dangerous substances and products when they are in the form in which they are placed on the market, but not necessarily in other forms of use, such as, for example, diluted.
Criteria for the classification of substances and products are in section 2-4. The classification includes location of the staging classes, the assignment of risk phrases (R-phrases) that specify the risks to the substance or product. In addition, danger symbols and indications of danger shall be assigned, cf. Section 2-4, as well as safety phrases (S-phrases), which provide instructions for necessary precautions, cf. Section 5.
Where a substance or product is classified as hazardous, it must be labelled with the indication of the danger to protect users, the public and the environment, cf. § 13, nr. 7. Detailed rules for this labelling are listed in Annex 2, Section 1.
The classification shall reflect all the dangerous properties of a substance or product. To that end, it is necessary to take account of the criteria in each of the paragraphs 2 and 4 of paragraphs 2 to 4. For example, classification is subject to section 3.2.1.1. not that, for example, section 3.2.1.2., 3.2.1.3. or 3.2.2.
Chemical substances shall be classified on the basis of the criteria set out in 2.2. (Fire and Explosion), 3.2. (Health Danger), and 4.2. (environmental effects). The classification shall be based on all available data on the substance.
An attempt to make use of substances within the framework of this notice shall be carried out in accordance with the requirements of Article 13 of Regulation (EC) No 2 of the European Parliament and of the Council. 1907/2006 on the registration, assessment and approval, as well as restrictions on chemicals (REACH).
In the case of substances, the information set out in Annexes VI, VII and VIII to Regulation (EC) No 2 of the European Parliament and of the Council is required. 1907/2006 on the registration, assessment and approval of, and restrictions on chemicals (REACH), most of the necessary data for classification and labelling are available in the base set. The classification and labelling must, where necessary, be reviewed when further information is available (Annex IX and X to Regulation (EC) No 2. 1907/2006). The data necessary for the classification of other substances shall be obtained from the following sources, in particular :
-WHAT?
the results of the examination of the substance ;
-WHAT?
the information required under international rules on the transport of dangerous goods ;
-WHAT?
information from the reference plants and the literature ;
-WHAT?
information stemming from practical experience,
-WHAT?
the results from structure / activity relationships and expert assessments.
The criteria referred to in Section 2.2, 3.2 and 4.2 shall apply for direct use when the relevant data has been obtained by means of investigation corresponding to the indicated in Annex 12. In other cases, the available data must be evaluated by comparing the methods used and the results of studies with the methods referred to in Annex 12 and the criteria referred to in point 2.2, 3.2 and 4.2., for the purpose of determination of the appropriate classification criteria.
In some cases, there may be some doubt as to the criteria set out in 2.2, 3.2 and 4.2. must be used, particularly when they require the use of expert opinion. In such cases, the manufacturer or importer shall classify the substance on the basis of a competent person's evaluation of the documentation. For approval products such as plant protection products and biocidal products, the classification shall be carried out by the competent authority.
Where an expert opinion is based on the classification of the substance, where there is fear of the possible inconsistent application of the criteria referred to in 2.2, 3.2 and 4.2, the relevant scientific data on which it is based is due ; the communication referred to in section 7 (3). 1, to the Environmental Management Board at its request. The same procedure shall be used when information is available which may raise doubts about the accuracy of the classification of a substance in the list of hazardous substances.
If, for a given characteristic, there are several sets of data, the data that results in the most stringent classification shall be used unless they have been obtained on the basis of studies that are scientifically incorrect.
Chemical products shall be classified for the fire and explosion hazard according to the same criteria as substances (point 2.2), cf. however item 2.3. As far as plant protection products are concerned, look at the point. 2.1.
In the case of a health hazard (toxicological properties) other than carcinogenic, mutagenic and toxic effects, chemical products shall be classified according to the same criteria as substances, cf. section 3.2.1. to 3.2.6, and / or using the methods described in 3.3. (calculation methods). For plant protection products, look at it. 3.1. As far as the R65 is concerned, the criterion is used in item 3.2.1.3.
For carcinogenic, mutagenic and toxic effects must chemical products are classified according to the methods described in 3.3.6.
In the case of environmental hazology (ecotoxicological properties), chemical products for toxicity in the aquatic environment shall be classified according to the same criteria as for substances or by using the methods laid down in Point 4.3. (method of calculation). For plant protection products, see section 4.1.
A product is classified for its ability to bioaccumulation and degradability according to the methods described in Point 4.3. (The calculation rules). The rules on calculation must also be applied in the classification of a product as dangerous for the ozone layer.
The data used to classify a chemical product using fact-finding data on the product shall be obtained by using the methods referred to in Annex 12. They shall be carried out in accordance with the principles of good laboratory practice in accordance with the rules applicable to the Security Management Board at any time. However, this does not apply to studies for physico / chemical properties for chemical products. If laboratory tests are carried out by a laboratory outside Denmark as a responsible laboratory, this must be subject to the supervision of the GLP authority of the country concerned, in accordance with the rules of the OECD, or otherwise ; documentation that GLP principles have been followed.
2.
CLASSIFICATION OF FIRE AND EXPLOSION RISKS
2.1.
Introduction
Substances and products shall be classified for explosive, oxidising of oxidising (oxidising) and flammable properties according to the criteria specified in this section. The criteria are directly indicated in the test methods set out in Annex 12, where such are specified.
The plant protection products covered by Chapter 7 of the law on chemical substances and products shall be classified according to the criteria laid down in this Title. These properties shall be determined by means of the methods set out in Appendix 12 unless other internationally accepted methods are acceptable in accordance with the publication of the control measures laid down in Annex 5.1.
Where there is sufficient evidence in practice that the physico-chemical properties of substances and products (other than organic peroxides) differ from those to show the test methods in Annex 12, such substances and products shall be classified as appropriate ; in accordance with the possible hazard they present to persons who consort with these substances and products, or to other persons.
The criteria contained in this section apply to both substances and products. If none of the content substances of a product are to be classified according to the criteria laid down in this Title, and the producer or importer has information, indicating that it is likely that the product involves the dangers of it in this section However, it is not necessary to examine whether the product is to be classified according to the criteria laid down in this Title.
The same applies if there is scientific evidence to assume that a new risk assessment in the event of a change to the well-known composition of a product will not lead to a change in classification. In the case of pesticides, studies must be carried out in accordance with the publication of the control measures laid down in Annex 5.1.
Specific rules have been laid down for certain gas mike products in item 2.3.
2.2.
Criteria for classification
2.2.1.
Explosive
In the case of explosive substances and products, fixed, liquid, gainous or gelatinous substances and products which, without the supply of oxygen, can react rapidly to heat-developers with rapid acceleration and which are detonated by the test conditions ; rapidly deflares or at a partial containment explodes or, at a time of heating, explode. Substances and products shall be classified as explosive and assigned the symbol " T" and the indication of danger ' in accordance with the results of the tests given in Annex 12, if the substances and products are explosive in the form they are concerned ; is marketed.
A R-statement is mandatory and it is selected on the basis of :
R2
Explosive for shock, friction, fire, or other sources of ignition
All explosive substances and products, including organic peroxides, except the above mentioned below.
R3
Highlight explosive for shock, friction, fire, or other sources of ignition.
Especially sensitive substances and products, such as the salts of picrinic acid, pentaerythritoltetranitrate (PETN).
2.2.2.
Brandnourishing
In the case of oxidising substances and products, substances and products which, in contact with other substances, especially flambates, react highly thermal developers. Substances and products shall be classified as oxidising and assigned the symbol " O " and the indication of danger ' Brandnourishing ` in accordance with the results of the studies referred to in Annex 12 (hereinafter referred to as ' Oxidizing properties ').
A R-statement is mandatory and is selected on the basis of the results of the survey, but in accordance with the following :
R7
Can cause fire
Organic peroxides, which are flammable even if they are not in contact with other combustiable materials.
R8
Brandfarlig on contact with flammable substances
Other oxidising substances or products, including inorganic peroxides, which may cause fire or increase the fire hazard of contact with combustiable substances.
R9
Explosive when mixing with flammable substances
Other substances and products, including inorganic peroxides, which are explosive when mixed with combustible substances, such as certain chlorates.
2.2.2.1.
Comments concerning peroxides
Organic peroxides combines a fire-nutrient and properties of a combustible substance in a molecule : when an organic peroxide is degraded, the oxidising part of the molecule is reacting to the oxidized part of the combustible parts of the fire hydrant (oxiderable) part.
As far as explosive properties are concerned, organic peroxides or products thereof are classified in the form in which they are placed on the market according to the criteria referred to in 2.2.1 on the basis of the tests carried out in accordance with the methods laid down in Annex 12.
As far as the oxidising properties are concerned, the existing methods can be used, cf. Annex 12 is not used on organic peroxides.
What? substances in the case of the classification of organic peroxides which are not already classified as explosive, which are dangerous on the basis of their structure (e.g. R-O-O-H, R, 1 -O-O-R 2 ).
Products not already classified as explosive shall be classified by applying the calculation method based on the percentage of active oxygen.
The active oxygen content (%) in a product with organic peroxide is determined by the formula :
16 x. (n). i x c i /m i ()
where :
n i = number of peroxic groups per molecule organic peroxide i
c i = concentration (weight percentage) of organic peroxide i
m i = molecular weight of organic peroxide i
Organic peroxides or products thereof which are not already classified as explosive shall be classified as oxidizing, if the peroxide or product contains :
more than 5% of organic peroxides, or
more than 0,5% active oxygen from the organic peroxides and not more than 5% of hydrogenperoxide.
2.2.3.
Highly flammable
Substances and products shall be classified as highly flammable and shall be assigned the symbol ' Exterior flammable `, in accordance with the results of the studies indicated in Annex 12.
The R-statement shall be assigned in accordance with the following criteria :
R12
Highly flammable
Liquid substances and products which have flamethroid lower than 0 ° C and oiling point (at the range of boiling range) lower than or equal to 35 ° C.
Gas-mike substances and products that can be ignanted at normal temperature and normal pressure.
2.2.4.
Very flammable.
Substances and products shall be classified as highly flammable and shall be assigned the symbol " Extreme dangerous " in accordance with the results of the studies indicated in Annex 12.
R-phrases are assigned according to the following criteria :
R11
Very flammable.
Fixed substances and products which are readily flammable by means of a source of ignition and which, following its removal, continue to burn or glow.
Liquid substances and products which have flamethroid lower than 21 ° C, but are not highly flammable.
R15
Reacts with water during the formation of highly flammable gases
Substances and products which, in contact with water or damp air, develop highly flammable gases in dangerous quantities, i.e. at least 1 litres per kilograms. per Hour.
R17
Self-combustible in air
Substances and products, which are at normal temperature and without power supply at the impact of the air, develop heat and then ign-ign-ignition.
2.2.5.
Flammable
Substances and products shall be classified as flammable in accordance with the results of the studies referred to in Annex 12. The R-statement shall be assigned in accordance with the following criteria :
R10
Flammable
Liquid substances and products which have flamepoint equal to or higher than 21 ° C and lower than or equal to 55 ° C.
However, a product which has flamelight equal to or higher than 21 ° C and lower than or equal to 55 ° C does not have to be classified as flammable if it cannot in any way be given a fire, and there is no reason to fear that it will lead to danger ; for persons handling it, or for other people.
2.2.6.
Other physico-chemical properties
Substances and products that are already classified according to section 2.2.1 to 2.2.5., 2.3. or in accordance with paragraphs 3 or 4, additional R phrases shall be assigned in accordance with the following criteria :
R1
Explosive in dry mode
Explosive substances and products placed on the market or in a moisture form, such as nitrocellulose, with a content of more than 12.6% nitrogen.
R4
Danner very sensitive explosive metal compounds
Substances and products capable of forming sensitive, explosive metallic derivatives, e.g. pic acid, styphninlic acid.
R5
Explosive for heating
Thermal unstable substances and products that are not classified as explosive, e.g. perchloric acid above 50%
R6
Explosive on and without contact with air
Substances and products which are unstable at room temperature, such as acetylene.
R7
Can cause fire
Reactive substances and products, such as fluoride, sodium hydrogensulphite.
R14
Reacts violently with water
Substances and products which react violently with water, such as acetylchloride, alkaline metals, titanium trachloride.
R16
Explosion hazardous when mixing with oxidising substances
Substances and products that react explosively with oxidizing funds, for example, red phosphorus.
R18
In use, fireable fumes / explosive steam-air mixtures are formed
Products not classified as flammable but which contain volatile components that are flammable in the air.
R19
Can create explosive peroxides
Substances and products which may constitute explosive peroxides during storage, e.g. diethyl ether, 1,4-dioxan.
R30
Can become very flammable when using
Products that are not themselves classified as flammable but which may be flammable due to the loss of non-flammable, volatile components.
R44
Explosive during containment of warm-up
Substances and products not themselves classified as explosive in accordance with point 2.2.1, but nevertheless exhibited explosive properties in practice if they are heated during sufficient containment. For example, certain substances may explode at a time of heating in a steel surge but not by heating in less solid containers.
Other additional R-phrases are listed in section 3.2.8.
2.3
Gas-mixing products (gas mixtures)
Gas mimige products shall be classified according to the criteria referred to in paragraph 2.2, with the following exceptions being applicable.
2.3.1.
Fire Farliness
In cases where gaseous products are produced on order in small quantities, the fire-risk of these gas mixtures may be evaluated according to the following calculation method :
The expression for the gaseous mixture
A 1 F 1 +. + A i F i +. A n F n + B 1 I 1 +. + B i I i +. B p I p
where :
A i and B i is an Moldovan
F i flammable gas,
I i inert gas
n number of flammable gases,
p number of inert gases
can be rewritten into a form where all you i (inert gases) expressed in a nitrogen equivalent during the use of a coefficient K, i , and where the equivalent content of the dangerous gas A ' i is expressed as follows :
AL2280_15_1.png Size : (121 X 34)
By using the value for the maximum content of flammable gases, which in a mixture of nitrogen, a mixture that is not flammable in air (Tci) can be achieved :
. i 'A' i /Tci ≤ 1
The gas mixture is flammable if the value of the above expression is greater than 1 and the product is classified as highly flammable. Moreover, the R12 statement is assigned.
Equivalencoefficients (R i ()
The value of the equivalence K i between the inert gases and nitrogen and the values of the maximum flammable gases (Tci) can be found in Tables 1 and 2 of ISO standard ISO/DIS 10156.
Maximum content of flammable gases (Tci)
The value of the maximum content of flammable gases (Tci) can be found in Table 2 of the ISO standard ISO/DIS 10156.
When a Tci-value for a flammable gas does not exist in the above standard, the corresponding lower explosive limit (LEL) shall be used. If no LEL value is found, the TEL value is set to 1% by volume.
Remarks
-WHAT?
The above expression may be used to obtain a fair labelling of gaseous products, but it should not be regarded as a method of substituting for the purpose of the determination of the technical safety parameters.
-WHAT?
Furthermore, this expression does not provide any information about whether a mixture containing oxidizing gases may be treated safely. The evaluation of the fire risk shall not be taken into account for these oxidizing gases.
-WHAT?
The above expressions provide reliable results only if the flammable gases do not affect each other in relation to their fire haziness. This has to be taken into account, for example, by halogenated hydrocarbons.
2.3.2.
Oxidising properties
As the directives listed in Annex 12 do not contain any method of determining the oxidizing properties of the gaseous mixers (oxidising) properties, these properties must be evaluated in accordance with the following method.
The principle of the method is based on a comparison between the oxidizing ability of the gases in a mixture and the oxidising capacity of the oxygen in air. The concentration of gases in the mixture is expressed in volume percentage.
The gases mixture are considered as oxidizing or more oxidizing than air if the following condition is met :
. i x i C i 2121
where
x i concentration of gas in% by volume and
C i is the equivalence coefficient,
In this case, the product shall be classified as oxidising and assigned the R8 R8.
Coefficient of equivalence between oxidising gases and oxygen
The following coefficients are used in the calculation of the oxidizing ability of certain gases in a mixture compared with the oxidising capacity of oxygen in air, calculated in paragraph 5.2. in ISO standard ISO/DIS 10156 :
O 2 : 1
N 2 O : 0,6
When no value for C i the coefficient exists for a gas in the specified standard, the coefficient shall be attributed to a value of 40.
3.
HEALTH HAZARD CLASSIFICATION
3.1.
Introduction
The classification of health concerns both acute effects and long-term effects of substances and products, whether they come from a single, repeated or long-term impact.
If, in the case of epidemiological studies, scientifically justified case studies as specified in this section or by statistical underused experience, so as to assess data from poisonous information lesions or from occupational diseases, be shown that the toxicological effects on humans are different from the effects of the methods used for the use of methods of animal testing or the use of the calculation method in 3.3. effects on humans. However, studies on humans must not be used and should not normally be used to refute positive data from animal testing.
In the case of several dangerous properties, there are authenticated in vitro methods in Annex 12, and these tests should be used where appropriate.
Where classification is carried out from the results of tests, studies from methodologies which reflect the risks that are relevant to the human being should be used in a suitable manner.
Classification of substances be carried out on the basis of the survey data available, in accordance with the criteria referred to in 3.2. The scope of these effects shall be taken into account.
For products classification shall be classified as a health hazard :
(a) On the basis of the classification of the incoming substances, using the calculation methods in 3.3.
b) according to the criteria referred to in 3.2. The properties shall be determined by means of the methods set out in Annex 12, with less for plant protection products other internationally accepted methods, in accordance with the publication of the control measures laid down in Annex 5.1.
Except for plant protection products to comply with the requirements of Annex 5.1, the methods laid down in paragraph (b) may be used only when the person responsible for marketing, scientifically, can prove that the product is : toxicological properties may not be calculated correctly according to the calculation methods in 3.3 or on the basis of existing animal tests. The test methods must also be justified or separately authorized in accordance with Article 12 of Directive 86 /609/EEC.
If a toxicological property is determined both based on the rules of a (a) and (b), the result obtained from point (b) is used for the classification of the product, with the exception of carcinogenic, mutagenic and reproduction properties, where the calculation methods in point 3.3 are calculated. must be used.
Irrespective of the method used to assess the risks of a product, account must be taken of all the dangerous health effects referred to in this Title. For example, classification is subject to section 3.2.1.1. not that, for example, section 3.2.1.2., 3.2.1.3. or 3.2.2.
If one or more toxicological properties of a product of known composition is assessed on the basis of fact-finding data, a new assessment shall be carried out, either on the basis of fact-finding data or using the calculation methods, in the following cases :
1)
if changes are made to the composition of the product, by replacing or inserting one or more substances, whether these substances are to be classified as dangerous or not,
2)
the concentration of one of the content substances classified for human health is changed. However, no further assessment needs to be made if the concentration of the concentration does not exceed the following limits :
Interval of the initial concentration of the substance
Allowed variation in the initial concentration of the substance (as a percentage of the initial concentration)
konc. ≤ 2.5%
± 30%
2,5% < konc. ≤ 10%
± 20%
10% < konc. ≤ 25%
± 10%
25% < konc. ≤ 100%
± 5%
The new assessment will be valid unless there are scientific reasons to assume that a new hazard assessment will not result in a change of classification.
Where impurities, additives or individual constituents of substances have been identified, account shall be taken of this where their concentration is greater than or equal to the following concentration limits :
-WHAT?
0,1% for substances classified as highly toxic, toxic or as carcinogenic, mutagenic or toxic to reproduction in category 1 or 2, or for the environment (assigned symbol N for its waters for the aquatic environment or the ozone layer),
-WHAT?
1% for substances classified as harmful, corrosive, irritant, sensitizing or as carcinogenic, mutagenic or toxic to reproduction in category 3, or dangerous to the environment (not assigned the symbol N, d.v.s. organisms living in water and / or may cause long-term adverse effects in the aquatic environment,
unless lower values are specified in the list of hazardous substances.
In the case of impurities, additives or individual components of the classification of a substance, the rules applicable to the classification of products shall be taken into account when the classification of products is to be classified.
Substances containing asbestos must not, however, be assessed in accordance with the rules for products before a concentration limit has been set in the list of hazardous substances.
3.2.
Criteria for classification based on survey data
3.2.1.
Acute lethal effects
Where classification is carried out from the results of tests, the results of methods which reflect the risks that are relevant to man should be used in an appropriate manner.
Acute toxicity to the oral administration of substances or products may be determined by means of a method which makes it possible to assess the LD 50 -the value, or by determining the critical dose (fastdosis-method) or by determining the exposure interval where mortality is expected (acute toxicity method).
The critical dose is the dose that results in clear signs of toxicity, but no fatalities, and shall be one of the four levels of dose specified in the method indicated in Annex 12 (5, 50, 500 or 2000 mg/kg body weight).
The term &apos; clear indication of toxicity ` shall be used as a description of toxic effects after exposure of the substance or product so serious that exposure to the next higher dose is likely to cause deaths.
The results of the examination at a particular dose after the dose dose method may be either :
-WHAT?
less than 100% survival,
-WHAT?
100% survival, but clear signs of toxicity,
-WHAT?
100% survival, no obvious signs of toxicity,
In certain cases, the fixed dose method requires that the substance or product be re-examined with a higher or lower dose if it has not already been examined at the appropriate level of dose. See also the evaluation table in test method B1 bis listed in Annex 12.
In the criteria referred to in 3.2.1.1., 3.2.1.2 and 3.2.1.3, only the final survey result is available. The dose of 2000 mg/kg shall above all be used to obtain information on the toxic effects of substances and products that display low acute toxicity and are not classed on the basis of acute toxicity.
The exposure interval, where mortality is expected, can be found on whether there are related deaths or not by the acute toxicity class method. In the first attempt, one of the three fixed initial doses (25, 200 or 2000 mg/kg body weight) is used.
The method of acute toxicity class requires, in certain cases, that the substance is re-examined with higher or lower doses, if it has not already been examined at the appropriate level of dose. See also the evaluation form in test method B. 1 ter in Appendix 12.
3.2.1.1.
Meget giftig
Substances and products are classified according to the following criteria as highly toxic and awarded the symbol Tx, the indication of danger &apos; Very Giftig ` and one or more of the following R-phrases :
R28
Meget giftig at indtagelse
acute toxicity,
-WHAT?
LD 50 oral, rat : ≤ 25 mg/kg, or
-WHAT?
Fastdose method : less than 100% survival at 5 mg/kg, oral, rat, or
-WHAT?
High mortality at dose ≤ 25 mg/kg oral, rat, by the acute toxicity class method (with regard to interpretation of test results, refer to the diagrams in Annex 2 for test method B. 1 ter in Appendix 12.).
R27
Meget giftig for hudkontakt
acute toxicity,
-WHAT?
LD 50 dermal, rat or rabbit : ≤ 50 mg/kg
R26
Meget giftig on inhalation
acute toxicity,
-WHAT?
LC 50 inhalation, rat, for aerosols and particulates : ≤ 0,25 mg/l/ 4 hours
-WHAT?
LC 50 inhalation, rat, for gases and vapours : ≤ 0,5 mg/1/4 hours
3.2.1.2.
Giftig
Substances and products shall be classified according to the following criteria as toxic and awarded the symbol &quot; T &quot;, the indication of danger &apos; Toxic ` and one or more of the following R-phrases :
R25
Giftig on indtagelse
acute toxicity,
-WHAT?
LD 50 oral, rat : 25 mg/kg < LD 50 ≤ 200 mg/kg, or
-WHAT?
Fastdose method : Critical dosage, oral, rat, 5 mg/kg : 100% survival, but clear signs of toxicity or
-WHAT?
High mortality in dosiarea > 25 to ≤ 200 mg/kg oral, rat, by the acute toxicity class method (with regard to interpretation of test results, refer to the diagrams in Annex 2 for test method B. 1 ter in Appendix 12.).
R24
Toxic to hudkontakt
acute toxicity,
-WHAT?
LD 50 dermal, rat or rabbit : 50 mg/kg < LD 50 ≤ 400 mg/kg
R23
Giftig by inhalation
acute toxicity,
-WHAT?
LC 50 inhalation, rat, for aerosols and particulates : 0,25 mg/1/4 hours < LC 50 ≤ 1 mg/1/4 hours
-WHAT?
LC 50 inhalation, rat, for gases and vapours : 0,5 mg/1/4 hours < LC 50 ≤ 2 mg/l/4 hours
3.2.1.3.
Harmful
Substances and products are classified according to the following criteria as harmful and assigned the symbol &quot; Xn &quot;, the indication of danger &apos; harmful to health `, and one or more of the following R-phrases :
R22
Hazable on intake
acute toxicity,
-WHAT?
LD 50 oral, rat : 200 mg/kg < LD 50 ≤ 2000 mg/kg, or
-WHAT?
Fastdose method : Critical dosage, oral, rat, 50 mg/kg : 100% survival, but clear signs of toxicity, or less than 100% survival at 500 mg/kg, oral, rat, see the evaluation table in test method B1 bis listed in Annex 12 or
-WHAT?
High mortality in dosiarea > 200 to ≤ 2000 mg/kg oral, rat, by the acute toxicity class method (with regard to interpretation of test results, refer to the diagrams in Annex 2 for test method B. 1 ter in Appendix 12.).
R21
Farlig on hudkontakt
acute toxicity,
-WHAT?
LD 50 dermal, rat or rabbit : 400 mg/kg < LD 50 ≤ 2000 mg/kg
R20
Farlig on inhalation
acute toxicity,
-WHAT?
LC 50 inhalation, rat, for aerosols and particulates : 1 mg/l/4 hours < LC 50 ≤ 5 mg / l / 4 hours
-WHAT?
LC 50 inhalation, rat, for gases and vapours : 2 mg/l/4 hours < LC 50 ≤ 20 mg/l/4 hours
R65
Farlig : may cause lung damage when ingestion
Liquid substances and products which, because of their low viscosity, constitute an aspirational hazard to humans :
a)
Substances and products which contain the aliphatic, alicyclic and aromatic hydrocarbons of a total concentration of 10% or more and which have either have
-WHAT?
an expiration time of less than 30 seconds. in a 3 mm ISO cup in accordance with ISO 2431 (the day of April 1996 /July 1999) relating to the "Paints and varnishes-Determination of flow time" " (paints and varnishes-determination of expiration time with the use of the expiry dates), or
-WHAT?
a kinematic viscosity measured by a calibrated glass capillary in accordance with ISO 3104/3105, in less than 7 x 10, -6 m 2 / sec. at 40 ° C, (ISO 3104, 1994-Release, concerning "Petroleum products-Transparent and opaque liquids-Determination of kinematic viscosity and calculation of dynamic viscosity" (oil products-transparent and opaque liquids-determination of kinematic viscosity and computation of dynamic viscosity) ISO 3105, 1994-Edition, regarding "Glass capillary kinematic viscometers-Specifications and related instructions" (kinematic glass capsumethree specifications and instructions)), or
-WHAT?
a kinematic viscosity, calculated on the basis of measurements by means of rotation in accordance with ISO 3219, in less than 7 x 10, -6 m 2 / sec. at 40 ° C. (ISO3219, 1993-Release, concerning "Plastics-Polymers / resins in the liquid state or as emulsions or dispersions-Determination of viscosity using a rotational viscomets with defined shear rate" (plastics-polymers / harpiks in floating state, or as emulsions or dispersions-determination of the viscosity by means of a rotational range, with a fixed offset speed)).
However, the classification of substances and products satisfying these criteria may be omitted if their average surface voltage is more than 33 mN/m at 25 ° C measured at the Nuoy tensiometer or by the measuring methods laid down in Part A. 5 of the conditions set out in Annex 12 ; mentioned testing methods.
b)
Other substances and products in the case of practical experience of human beings.
3.2.2.
Non-lethal, but irreversible effects after a single exposure
3.2.2.1.
Meget giftig
Substances and products must, according to the following criteria, be classified as highly toxic and awarded the symbol Tx, the indication of danger "Very toxic" and the R-statement :
R39 2)
Hazard for varig alvorlig skade på Health
-WHAT?
greater likelihood that, in addition to the effects referred to in 3.2.7, irreversible damage is caused by a single influence in a given way, generally at doses of the magnitude referred to in section 3.2.1.1.
3.2.2.2.
Giftig
Substances and products must, according to the following criteria, be classified as toxic and awarded the symbol &quot; T &quot;, the indication of danger &apos; Toxic ` and the R-statement :
R39 3)
Hazard for varig alvorlig skade på Health
-WHAT?
greater likelihood that, in addition to the effects referred to in 3.2.7, irreversible damage to a single influence is likely to be damaged in a given way, in general by doses of the magnitude referred to in section 3.2.1.2.
3.2.2.3.
Harmful
Substances and products must, according to the following criteria, be classified as harmful and assigned the symbol &quot; Xn &quot;, the indication of danger &apos; health-harmful ` and the R-statement :
R68 4)
Mutability for varig skade in Health
-WHAT?
greater likelihood that, in addition to the effects referred to in 3.2.7, irreversible damage to a single influence is likely to be damaged in a given way, in general by doses of the magnitude referred to in Item 3.2.1.3.
3.2.3.
Serious adverse effects on repeated or prolonged exposure
Substances and products must, according to the following criteria, be classified as toxic or harmful and assigned the symbol &quot; T &quot; or Xn, the indication of danger &apos; Toxic ` or &apos; Sundance `, and the R-statement :
R48 5)
Serious health hazard on longer exposure
-WHAT?
likely to cause severe damage to the repeated or sustained impact of a given application method (obvious dysfunction or morphological modification of toxicological importance).
Substances and products are classified at least as toxic when these effects are observed at dose levels, which are a size lower (that is to say. 10 times lower) than those listed below.
Substances and products are classified at least as harmful when these effects are observed at dose levels of the following magnitude :
-WHAT?
oral, rat : ≤ 50 mg/kg (bodyweight) /day
-WHAT?
dermal, rat or rabbit : ≤ 100 mg/kg (bodyweight) /day
-WHAT?
inhalation, rat : ≤ 0,25 mg/l, 6 hours / day
These indicative values may be used immediately when, in the case of subchronic toxicity (90 days), serious damage has been observed. In interpretation of the results of the subakut test (28-day) toxicity, these values should be approximately Three times bigger. In the case of chronic toxicity studies (2 years), an evaluation should be carried out on a case-case-case basis.
If results of studies of different duration are available, the results of the study of the longest duration standard should be used.
Comments regarding the use of R48
This R-statement is used to refer to particular biological effects of the kind described in the below. For the purpose of applying this R statement, serious injury shall be deemed to include death, clear function disturbances or morphological changes to toxicological significance. It is particularly important to use it when these changes are irreversible. It is also important that serious changes are not taken into account not only in a single body or biological system, but also to general changes of less serious nature in several bodies or serious changes in the general ; state of health.
When assessing whether there is any evidence of such effects, it should be reviewed according to the following guidelines.
1.
Characters of R48 should be used :
a)
Freed deaths
b)
i)
Major functional changes in the central nervous system or in the peripheral nervous system, including surveys, hearing and smelling, assessed in clinical observations or other appropriate methods (e.g. electrophysiology).
(ii)
Greater functional changes in other organ systems (e.g. in the lungs).
c)
Any persistent changes in parameters of clinical biochemistry, haematology or urethra, indicating severe malfunction in one or more bodies. Hematological disorders are considered to be of particular importance if there are signs that they are due to the reduction of bone marrow production of blood cells.
d)
Serious organ damage detected by microscopic studies of tissue after autopsi :
i)
Exhibit or severe formation of necrosis, fibrosis or granuloma in vitals with regenerative capacity (e.g. liver).
(ii)
Serious morphological changes that are potentially reversible, but clearly indicative of significant malfunctions (e.g. serious change in the liver's obesity, severe acute tubular nefrosis in kidney, ulcerous gastritis).
(iii)
Signs of significant cell death in vitals which cannot regenerate (e.g. fibrosis in the heart of the cardiac or the inclination of a nerve) or in stem cell populations (e.g. aplasia or hypoplasia in the bone marrow).
The above evidence will usually be obtained from animal testing. Where data from practical experience are used, special attention should be paid to dose levels.
2.
Characters of R48 should not be used :
The use of this R statement is limited to &apos; serious health hazard for longer exposure '. A number of drug-related effects can be observed, both with people and animals who do not justify the use of R48. These effects are relevant when trying to determine a level in which a chemical substance does not have any effect. As examples of well-documented changes which do not normally justify the classification of R48, irrespective of their statistical significance, the following may be mentioned :
a)
Clinical observations or changes in bodily increases, food or water intake, which may have a certain toxicological meaning but which are not in themselves any 'serious health hazard'.
b)
Minor changes in clinical biochemistry, haematology or urine analysis, which are of dubious or negligible toxicological significance.
c)
Changes to the body &apos; s weight without signs of malfunction in the bodies concerned.
d)
Customization responses (e.g., immigration of macros in the pulmonary tissue, liver hypertrophy and enzyme reduction, hyperplastic reactions to irritant substances). Local reactions to the skin due to repeated dermal use of a substance which is better classified by R38 "Irritating to Skin."
(e)
Where there is a certain species-specific toxicity mechanism (e.g. through specific metabolic pathways).
3.2.4.
Remarks for very volatile substances
In particular substances in respect of which the concentration of saturated vapors is high, there may be indications of effects which cause concern. Such substances may not be classified according to the criteria for health impact in this Annex (section 3.2.1.3., 3.2.2.3 and 3.2.3), or are not covered by item 3.2.8. However, where there is sufficient evidence that such substances may give rise to risks during normal handling and use, it may be necessary to classify them by individual assessment and to include them in the list of hazardous substances.
3.2.5.
Agrating and irritant effects
3.2.5.1.
Ate
The substance or product shall be classified as corrosive and assigned the symbol &quot; C &quot; and the indication of danger &quot; corrosive ` shall be classified according to the following criteria :
-WHAT?
A substance or product shall be deemed to be corrosive when, on an animal's undamaged skin, the death of at least one animal shall be produced in at least one animal in the test for skin irritation referred to in Annex 12, or under an equivalent method ;
-WHAT?
The classification can be based on results from authenticated in vitro tests to which those referred to in Annex V (B). 40. Skin corrosion : measure of transcutaneous electrical resistance (TER) in pigskin and a test where a human skin model is used.)
-WHAT?
A substance or product should be considered to be corrosive if the result is possible to predict, for example, from a strong acid or alkali reaction (measured pH of 2 or less or 11,5 or above). However, where extreme pH values form the basis for the classification, account may also be taken of the base or the acid reserve. J.R. Young, M.J. How, A.P. Walker and W.M.H. Worth (1988 'Classification as corrosive or irritant to skin of preparations containing acidic or alkaline substances, without testing on animals' Toxic. In Vitro 2 (1) : 19-26). If the basic or acid appraisal of the reserve is estimated that the substance or preparation is not corrosive, further testing should be carried out at any time by the use of an appropriate validated validation ; in vitro Attempto. The evaluation of the basic or acid reserve should not be used alone to exclude substances or preparations from classification as corrosive.
R-phrases are assigned according to the following criteria :
R35
Severe corrosion
-WHAT?
if there is no more than three minutes of exposure to an animal's undamaged skin, or this result may be predicted.
R34
Ectsdanger
-WHAT?
if there are not more than four hours of exposure, deep-range tissue death in an animal's undamaged skin, or this result may be predicted.
-WHAT?
organic hydroperoxides, unless documentation is available for the contrary.
Remarks :
Is the classification based on results from an authenticated in vitro attempts, used R35 or R34, depending on the possibilities of the test method, to distinguish between these.
If the classification is based only on an extreme pH value, R35 should be used.
3.2.5.2.
Locator
Substances and products shall be classified as irritant and shall be assigned the symbol &quot; Rotating &quot; and one or more of the following R-phrases in accordance with the following criteria.
1.
Inflammation of the skin
R38
Irritating to skin
-WHAT?
Substances and products which cause significant inflammation of the skin, which after an impact time of not more than four hours, performs at least 24 hours, intended for rabbits in accordance with the skin irritation test shown in Annex 12.
The inflammation is significant
-WHAT?
where the mean of the scores obtained for either blushing and crust or liquid collection, intended for all animal testing, is 2 or more ;
-WHAT?
or, where the sample referred to in Annex 12 is carried out on three animals, if the mean value of either blushing and crust or liquid collection, calculated for each animal, two or more animals equal to 2 or more.
In both cases, each of the scores (24, 48 and 72 hours) each of which is obtained in the calculation of the respective middle values.
The inflammation of the skin shall also be significant if it relates to at least two animals until the end of the observation period. Special effects such as, for example, swelling, scales, discoloration, cracks, crusts, crusts and hairs must be taken into account.
The relevant data may also be obtained from non-acute animal testing (see the explanatory notes to R48, paragraph 2 (d). These are considered to be significant if the visible effects correspond to the described above.
-WHAT?
Substances and products which cause significant inflammation of the skin, on the basis of practical observations in human beings, immediately, longer or repeated contact.
-WHAT?
Organic peroxides, unless evidence is available for the contrary.
Paresthesia
Paresthesia, which arises in people's skin contact with pyrethroid pesticides, is not considered to be an irritating effect, which is gracified as Xi ; R38. However, S-sentence S24 should be used for substances which may produce this effect.
2.
Eye damage
R36
Irritating to eyes
-WHAT?
Substances and products which, according to the application in the eye of the experimental animal, cause significant eye damage to be shown in the course of 72 hours after the impact, and which will remain at least 24 hours.
Ecular damage is significant if the mean value of the scores obtained under the eye irritation test given in Annex 12 corresponds to one of the following values :
-WHAT?
or more ambiguity in the cornea hinden of 2 or more, but less than 3 ;
-WHAT?
irrigor damage to 1 or more, but not more than 1,5,
-WHAT?
Redcoating the hyphenated in 2,5 or more
-WHAT?
the hyphenation in the hyphenum (chemosis) of 2 or more,
or, when the test referred to in Annex 12 has been carried out on three animals if the damage to at least two animals corresponds to one of the above levels other than in irany damage which must be greater than 1 but less than 2, and the value of the red-forming part of the hyphenal value ; must be either 2.5 or more.
In both cases, all of the loading dates (24, 48 and 72 hours) are taken into account in the calculation of the respective middle values.
-WHAT?
Substances and products which cause significant eye damage, on the basis of practical observations in human beings.
-WHAT?
Organic peroxides, unless evidence is available for the contrary.
R41
Risk of severe eye injury
-WHAT?
Substances and products which, according to the application in the eye of the experimental animal, are causing serious damage to the eye injuries during the course of 72 hours after the impact, which shall be at least 24 hours after the introduction of the test material.
Eyelisions are serious if the average value of the scores obtained under the eye irritation test specified in Annex 12 corresponds to one of the following values :
-WHAT?
ambiguity in the cornea of 3 or more ;
-WHAT?
irris; or more than 1,5 or more.
The same applies if the test has been carried out on three animals and the damage to at least two animals is at one of the following values :
-WHAT?
ambiguity in the cornea of 3 or more ;
-WHAT?
iris damage to 2.
In both cases, all of the loading dates (24, 48 and 72 hours) are taken into account in the calculation of the respective middle values.
Eyewitness damage is also serious if they are still present after the end of the observation period.
Eyelisions are also serious if the substance or product causes a durable approach.
-WHAT?
Substances and products that cause serious damage to eye injuries, on the basis of practical observations in human beings.
Note :
The classification of a substance or product as corrosive to the R34 or R35 phrases shall also be considered to pose a risk of serious injury to the cause, and therefore R41 is not included on the label.
3.
Irritation of the respiratory system
R37
Irriterer respirators
Substances or products which may cause severe irritation of the respiratory system, on the basis of :
-WHAT?
practical observing of human beings,
-WHAT?
positive results from appropriate animal testing.
Comments regarding the application of R37
In the interpretation of practical observations in people, they must carefully distinguish between effects that lead to classification with R48 (see furtive. 3.2.3), and effects which lead to classification with R37. The conditions normally leading to classification with R37 are reversible and usually limited to the upper airways.
Positive results from appropriate animal testing may include data obtained by a general toxicity study involving histopathological data from the respiratory system. Data from measurements of experimental bradylatitude (short-spirited) may also be used for the assessment of airway sirarity.
3.2.6.
Sensitizing effects
3.2.6.1.
Sensitivity by inhalation
Substances and products must, according to the following criteria, be classified as sensitizing and assigned the symbol &quot; Xn &quot;, the indication of danger &apos; to the danger &apos; and the R-statement :
R42
Can cause sensitization by inhalation
-WHAT?
if there is evidence that the substance or product may cause specific sensitisation by inhalation ;
-WHAT?
if there are positive results from appropriate animal tests,
-WHAT?
where the substance is an isocyanate, unless there is evidence that the substance does not cause sensitisation by inhalation.
Comments regarding the use of R 42 :
Documentation from humans
Proof that the substance or product may cause specific sensitisation by inhalation will normally be based on experience from humans. In this context, sensibility is seen as asthma, but other sensitivity reactions like rhinitis and alvepolicies also take into account. The condition has a clinical nature of an allergic reaction. However, it is not necessary to demonstrate immunological mechanisms.
In the examination of evidence from exposure to humans, the decision to classify it must, in addition to the documented cases, take into account :
-WHAT?
the size of the exposed population,
-WHAT?
the extent of exposure.
The documentation referred to above may be :
-WHAT?
clinical history and data from appropriate pulmonary function tests placed in relation to exposure to the substance, confirmed by other supporting documents which may include :
-WHAT?
a similar chemical structure such as the substances known to cause sensitisation by inhalation ;
-WHAT?
in vivo immunological tests (e.g., a priktest)
-WHAT?
in vitro immunological tests (e.g. serological analyses),
-WHAT?
studies to show other specific but non-immunological action mechanisms, such as the repeated faint irritation and pharmacological induction ;
-WHAT?
data from positive bronchial provocation tests with the substance, carried out in accordance with accepted guidelines for the determination of a specific sensitivity reaction.
Clinical cover story should cover both medical and professional history to detect a causal relationship between exposure to a particular substance or product and development of sensitisation by inhalation. Relevant information encomplicates worsening factors, both at home and in the workplace, the beginning and development of the disease and the family history and medical history of the patient concerned. The medical history should also include allergic diseases or respiratory diseases from childhood, and smoking habits.
The results of positive bronchial provocation tests are considered to be sufficient evidence to classify as sensitising. It must be recognised, however, that many of the studies mentioned above in practice will already be carried out at an earlier stage.
Substances which only induction asthma symptoms to irritation in persons with bronchial hyperreactivity should not be required for the R-42 statement to be specified.
Animal trials
Data from tests to indicate that a substance or product may cause sensitisation by inhalation of human beings may include :
-WHAT?
IgE measurements (e.g. in mice)
-WHAT?
specific pulmongers for guinea pigs.
3.2.6.2.
Sensitivity on skin contact
Substances and products shall be classified as sensitizing and assigned the symbol &quot; Xi &quot;, the indication of danger &apos; Rotating ` and the R-statement :
R43
Can cause sensitisation by contact with the skin
-whose practical experience shows that the substances and products cause sensitisation by a significant number of persons in contact with skin contact,
-on the basis of positive results from an appropriate animal study ;
Comments regarding the application of R 43 :
Documentation from humans
The following documentation (practical experience) is sufficient to classify a substance with R43 :
-positive data from appropriate cargo samples, normally from more than one dermatological clinic, or
-epidemiological studies which show that the substance or product has caused allergic contact dermatitis. Situations in which a high percentage of exposed persons show characteristic symptoms must be considered to be particularly serious, even though the number of cases is low, or
-positive data from experimental studies on human beings (see, however, furtive. 3.1).
The following shall be sufficient to classify a substance with R43 when supporting documentation is provided :
-isolated cases of allergic contact dermatitis, or
-epidemiological studies, where cases, systematic errors (bias) or unhandled contexts (confounders) have not been completely excluded.
Supporting supporting documents may include :
-data from animal testing carried out according to the applicable guidelines, with a result that does not satisfy the criteria laid down in the section on animal studies, but which are sufficiently close to the border to be considered significant, or
-data from non-standardized methods, or
-relevant relationships between structure and activity.
Animal studies
As positive results from appropriate animal experiments are considered :
-a response of at least 30% of the test animals if the test method of the adjuqueal type of the skin sensitisation is referred to in Annex 12 or other test methods of the adjusting type of adjuvolous type.
-For all other fact-finding methods, a response to at least 15% of the test animals is considered to be positive.
3.2.6.3
Immunological contact ticeria (non-oedefect)
Some substances and products which meet the criteria for R 42 may also cause immunological contact-aria. In such cases, information on contact turticaria should be included in the use of suitable S-phrases, usually S 24, and S 36/37, and in the supplier instructions.
For substances and products showing signs of immunological contact-aria, but which do not meet the criteria for R42, the classification with R 43 should be considered.
There is no such thing as a recognised animal model to identify substances that cause immunological contact-aria. The classification will, therefore, normally have to be based on documentation of people who correspond to the rules of sensitisation by skin contact (R 43).
3.2.7.
Carcinogens, mutagenic and toxic effects
3.2.7.1.
Carcinogens
For the classification, these substances shall be divided into account, taking into account the current knowledge of three categories :
Carcinogenic Category 1 (category Carc1) :
Substances known to provoke cancer in human beings. There is sufficient evidence for a causal relationship between human exposure to the substance and the development of cancer.
Carcinogenic Category 2 (category Carc2) :
Substances which should be regarded as provoking cancer in human beings. There is sufficient evidence to provide strong grounds for the effect that the effects of the substance in human beings may cause cancer, generally on the basis of :
-WHAT?
appropriate long-term animal testing,
-WHAT?
other relevant information.
Carcinogenic Category 3 (category Carc3) :
Substances which give cause for concern, as they may be able to provoke cancer in human beings, but for which there is insufficient information to carry out a satisfactory assessment. There we are. s see signs from relevant animal tests, but these are insufficient to place them in category 2.
3.2.7.1.1.
The following danger symbols and R-phrases shall apply :
Categories Carc1 and Carc2 :
T ; R45 : May cause cancer
For substances and products which only involve the hazards of inhalation, such as dust, ponds or smoke (whereas other influavenues such as intake or skin contact do not involve any risk to cancer), the following symbol and R-phrase should be used :
T, R49 : Can inducer cancer by inhalation
Category Carc3 :
Xn ; R40 : Possibility of carcinogenic effect
3.2.7.1.2.
Detailed criteria for the classification of carcinogenic substances
The location of a substance in category Carc1 shall be carried out on the basis of epidemiological data ; the location in category Carc2 and Carc3 is based mainly on the basis of animal tests.
For classification as a carcinogen in category Carc2, either positive results from two animal species or clearly positive effects from an animal species supported by, among other things, genotoxic data, metabolic or biochemical studies, the presence of good tumors, structural similarities with other carcinogenic substances or data from epidemiological studies, which indicate a connection.
Category Carc3 includes two sub-categories :
a)
substances which have been thoroughly investigated, but where the documentation for the tugenous effects is insufficient for classification in category 2, further attempts are not expected to produce additional information that may be relevant for : the classification.
b)
substances which are not sufficiently investigated. The data that are available are inadequate, but it gives cause for concern for man. This classification is provisional ; further attempts are necessary before a final decision can be taken.
In the case of Category Carc2 and Carc3, the following arguments are relevant, reducing the importance of experimental tumors for the possible human exposure possible. These arguments will, in particular, when combined, in most cases lead to classification category Carc3, even if the tumors have been produced in animals :
-WHAT?
only the carcinogenic effects of very high dose levels exceeding the maximum tolerated dose `. The maximum tolerated dose is characterized by toxic effects which, although not reducing the life of the animal, are accompanied by physical changes, such as 10% reduced growth,
-WHAT?
Tumorous occurrences, in particular at high levels of dose, which are only occurring in certain animal species in certain animal species, which are known to be particularly inclined to show comprehensive spontaneous tumoration,
-WHAT?
in the case of an application site in very sensitive test systems (e.g., application under the skin or within the bughul of certain local active connections) if the particular target body is not relevant to humans ;
-WHAT?
the absence of genotoxicity in short-term studies in vivo and in vitro,
-WHAT?
presence of a secondary mechanism, which in practice means that there is a threshold at a certain dose level (e.g. hormonal effects in the target organs or on physiological regulatory mechanisms and chronic stimulus of the cell division),
-WHAT?
presence of a species-specific tumoration mechanism (e.g. through specific metabolic mechanisms) that are not applicable to man.
In the case of Category Carc3 and non-classified substances, such arguments are relevant, which exclude concern for human beings :
-WHAT?
A substance shall not be classified in any of the categories if the mechanism responsible for the tumoreformation during the tests is clearly identified and there is good evidence that this process cannot be extrapolated to humans.
-WHAT?
If the only cryo-data that exists is the liver tumours in certain sensitive clams, without any other supporting documentation, this substance cannot be classified in any of the categories.
-WHAT?
Special attention must be given to cases where the only cryo-data that exists is related to the presence of neoplasm in places and in breeds, where it is well known that they often occur spontaneously with a high frequency.
3.2.7.2.
Mutagenic substances
For the classification, these substances shall be divided into account, taking into account the current knowledge of three categories :
Mutagen category 1 (category Mut1) :
Substances which are known to have mutagenic effects on man.
There is sufficient evidence of a causal link between the impact of the substance on human and heredic damage to the genetic material.
Mutagen Category 2 (category Mut2) :
Substances which should be regarded as having mutagenic effects on the human person.
There are sufficient evidence to provide strong grounds for the effect that the human exposure of the substance may result in heredial damage to the genetic material, generally on the basis of :
-WHAT?
appropriate animal testing,
-WHAT?
other relevant information.
Mutation Category 3 (category Mut3) :
Substances which give cause for concern, as they may have mutagenic effects. Evidence is available from mutagenicity studies, but it is insufficient to place the substance into category 2.
3.2.7.2.1.
The following danger symbols and R-phrases shall apply :
Category Mut1 :
T ; R46 : May cause heredial genetic damage
Category Mut2 :
T ; R46 : May cause heredial genetic damage
Category Mut3 :
Xn ; R68 : Possibility of permanent damage to health
3.2.7.2.2.
Detailed criteria for the classification of mutagenic substances
Expression Definition :
A mutation is a permanent change in the genetic material or structure of the genetic material of an organism which results in a change in the phenotypic properties of the organism. The changes may cover a single gen, a regroup or a whole chromosome. Effects that include a single gene can be a result of effects on individual DNA bases (point mutations) or large changes, including the deletion of the gene within the gene. Effects on whole chromosomes may include structural or numerical changes. A mutation in the germ cells of organisms with gender propagation can be disinherited to the offspring. A mutagen is a substance that raises or increases the number of mutations.
Substances shall be classified as mutagenic, with particular reference to genetic damage to heredic genetic damage. It should be noted that the kind of results that lead to the classification of substances in category Mut3 : 'the emergenation of genetic relevant events in somatic cells' is generally considered as a warning of possible carcinogenic activity.
The development of methods for mutagenicity studies is an ongoing process. For many new methods, there are no standardised protocols and evaluation criteria. The evaluation of mutagenicity data must be considered on the quality of the conduct of the study and the extent of the validation of the method must be assessed.
Category Mut1 :
In order to place a substance in category Mut1, positive evidence from epidemiological studies on human mutation is a positive one. Examples of such substances are not known to date. It is extremely difficult to obtain reliable information from studies on the effects of mutations in human populations, or whether greater mutation frequency may be increased.
Category Mut2 :
In order to place a substance in category Mut2, positive results are needed from studies showing :
2 (a)
mutagenic effects,
2 (b)
other cellular interactions in relation to mutagenicity in mammalian cells in vivo, or
2 (c)
mutagenic effects in mammal somatic cells in vivo combined with clear evidence that the substance or the relevant metabolit reaches the holding cells.
For the purposes of category Mut2, the following methods are currently appropriate :
Ad 2a)
In vivo mutagenicity studies on germ cells :
-WHAT?
the method of detection of mutation within a particular locus,
-WHAT?
method of detection of hereditary translocation,
-WHAT?
method of detecting dominant fatso,
These studies show, in fact, the presence of affected offspring or a defect in an embryo in development.
by 2 b)
In vivo studies, which show relevant interaction with germ cells (usually DNA) :
-WHAT?
method of detecting chromosomes, as demonstrated by cytogenic analyses, including aneidi, caused by incorrectly splitting of chromosomes ;
-WHAT?
method of detecting sisterling exchange exchanges (SCE),
-WHAT?
detection of non-replanting DNA-synthesis (UDS),
-WHAT?
the method of showing (covalent) binding of the mutagen to cell-DNA
-WHAT?
method of detecting other forms of DNA damage,
These studies give more or less indirect evidence. Positive results from these investigations will normally be supported by positive results from in vivo mutagenicity studies on somatic cells, in mammals or in people (see no. 3, preferred methods as No 3 (a).
by 2 c)
In vivo studies, which show mutagenic effects in mammals in somatic cells (see No, 3 (a), combined with two ksiko-kinetic methods or other methods which may show that the substance or the relevant metabolit reaches the holding cells.
For 2 (b) and (2) (c), it may be considered to use positive results from the host-mediated studies or the detection of clear effects in in-vitro studies as supplementary documentation.
Category Mut3 :
In order to place a substance into category Mut3, there is a need for positive results from studies showing
3 (a)
mutagenic effects, or
3 (b)
other cellular interactions that are relevant to mutagenicity in somatic cells in mammals in vivo.
In particular, the latter would normally be supported by positive results from in vitromutagenicity studies.
For the effects of somatic cells in vivo, the following methods are currently appropriate :
by 3 (a),
In vivo studies concerning mutagenicity in somatic cells
-WHAT?
bone marrow micronucleus test or metaphased analysis ;
-WHAT?
metaphases analysis in peripheral lymphocytes
-WHAT?
mouse spot test (colour stains on mouse skin)
ad 3 (b)
In vivo studies concerning the DNA interactions in somatic cells :
-WHAT?
method of detecting cuttinage exchange exchanges (SCE) in somatic cells ;
-WHAT?
method of detection of non-replanting DNA-synthesis (UDS) in somatic cells ;
-WHAT?
the method of showing (covalent) binding of mutagen to DNA in somatic cells,
-WHAT?
method of detecting DNA injuries, for example in the Baseline of somatic elution, in somatic cells.
Substances which show only positive results in one or more in vitro mutagenicity studies should normally not be classified. However, it is highly recommended to carry out further studies with in vivo studies. In exceptional cases, for example, by a substance which shows strong reactions in several in vitro studies and in which relevant in vivo data are not available, and which also exhibit similarities with known mutagenic / carcinogens, can classification in category Mut3 are considered.
3.2.7.3.
Toxic to reproduction
For the classification, these substances shall be divided into account, taking into account the current knowledge of three categories :
Reproductive Toxic Category 1 (category Rep1)
Substances that are known to dephate people's reproductive abilities. There is sufficient evidence for a causal relationship between the exposure of human exposure to the substance and phoned reproductive efficiency.
Substances known to cause damage to people's offspring. There is sufficient evidence for a causal relationship between the exposure of human exposure to the substance and subsequent damage to the offspring.
Reproductive Toxic Category 2 (Category Rep2)
Substances which should be considered to prejudice the reproductive ability of humans. The existence of sufficient evidence to ensure that human exposure to the substance may lead to reproductive efficiency, in general, on the basis of :
-WHAT?
clear evidence from animal testing to premediate reproductive capability without simultaneous toxic effects, or proof of abdication of reproductive ability to occur around the same dose level as other toxic effects, without being a secondary ; non-specific result of the other toxic effects ;
-WHAT?
other relevant information.
Substances which should be regarded as causing harm to offspring. There are sufficient evidence to ensure that the exposure of human exposure to the substance may result in damage to the offspring generally on the basis of :
-WHAT?
clear results from appropriate animal tests, where there have been observed injuries at a dose level without at the same time significant maternel toxicity, or at a dose level, causing other toxic effects, but where the damage is done ; the offspring is not a secondary, non-specific consequence of such other toxic effects ;
-WHAT?
other relevant information.
Reproductive Toxic Category 3 (Category Rep3)
Substances which give rise to concern in terms of human reproductive ability , generally on the basis of :
-WHAT?
results from appropriate animal tests, which provide sufficient evidence to feed strong reproductive performance in the absence of other simultaneous toxic effects or of deteriorating reproductive capacity, or at the dose level, which causes other toxic effects where the phoned reproductive ability is not a secondary, non-specific result of such other toxic effects, but where the documentation is not sufficient to place the substance in category 2 ;
-WHAT?
other relevant information.
Substances which give rise to concern about damage to human offspring in general on the basis of :
-WHAT?
results from appropriate animal tests, which provide sufficient evidence to sustain a dose of damage to the offspring at a dose level without at the same time significant maternel toxicity, or at a dose level, causing other toxic levels ; effects, but where the damage to the offspring is not a secondary, non-specific result of other toxic effects, but where the documentation is not sufficient to place the substance in category 2 ;
-WHAT?
other relevant information.
3.2.7.3.1.
The following danger symbols and R-phrases shall apply :
Category Rep1 :
For substances which prejudice the reproductive ability of humans :
T ; R60 : Can damage reproductive sleep
For substances causing damage to offspring :
T ; R61 : May harm the child during pregnancy
Category Rep2 :
For substances which should be regarded as to prejudice the reproductive ability of humans :
T, R60 : Can damage reproductive sleep
For substances which should be considered to cause damage to human beings :
T ; R61 : May harm the child during pregnancy
Category Rep3 :
For substances giving rise to concern regarding the reproductive ability of humans :
Xn ; R62 : Possibility of prejudice to reproductive function
For substances which cause concern for the damage to human offspring :
Xn ; R63 : Possibility of the damage to the child during pregnancy
3.2.7.3.2.
Detailed criteria for the classification of toxic to reproduction
Reproductive toxicity shall include the deterioration in the reproductive function or ability of men and women and the resulting non-inheritance harmful effects of the offspring. There is the possibility of classifying two main groups : 1) the effects on the reproductive ability of men and women and of 2) damage to the offspring.
1)
Effects on the reproductive ability of men and women, includes harmful effects on libido, sexual behaviour, all aspects of spermatogeneses or oogeneses or hormonal activity or physiological responses which may interfere with reproductive function, the reproductive system itself or the development of it ; fertilised eggs up to and including the implantation.
2)
Damage to the offspring, in its broadest sense, all effects that interfere with the normal course of development, both within and after birth. It shall include both effects caused or show prior to the birth of an effect that is first to be expressed after birth. This includes embryo toxic / phototoxic effects such as reduced body weight, growth and development deceleration, organ toxicity, death, abortion, structural defects (teratogenic effects), functional defects, peri and postnatal defects ; and hauled postnatal mental or physical development to and including normal puberty development.
The classification of chemical substances as toxic to reproduction is intended for chemical substances which have an inherent or specific property that provoke such toxic effects. Chemical substances should not be classified as toxic to reproduction if these effects only arise as a non-specific secondary consequence of other toxic effects. The chemical substances that give rise to most concern are substances which are toxic to reproduction at exposure levels, which do not cause any other signs of toxicity.
The location of a chemical substance in category Rep1 for effects on reproductive performance and / or damage to the offspring shall be based on epidemiological data. The position in Category Rep2 or Rep3 is based mainly on data from animal testing. Data from in vitro studies or studies from bird eggs shall be considered as 'supporting evidence' and will only lead exceptionally to the classifications in the absence of in vivo data.
As is the case for most other types of toxic effects, substances that display reproduction toxicity are suspected of having a threshold below which does not cause harmful effects. Even where significant effects are apparent during animal experiments, the meaning of human beings may be doubtful due to the doses used, for example where the effects have only shown in high doses or where there are two-ksikinetic differences ; or the application method is not applicable. These or similar reasons may cause the substance to be classified in Category Rep3 or, if any, are not at all classified.
In the methods set out in Annex 12, a limit test for substances with low toxicity is specified. If a dose level of at least 1000 mg/kg at oral reproduction does not give any indication of reproduction effects, then attempts at other dose levels may be considered superfluous. If data are available from studies carried out with higher levels of dose than the above limit dose, then these data shall be evaluated together with other relevant data.
Under normal circumstances, effects which are only at higher doses other than the limit doses may not necessarily be classified as reproduction toxicity.
Effects on reproductive ability
In order to classify a substance in category Rep2 for phyphyphyphyreproduction, a clear evidence of such effects must normally be available in an animal species with supporting evidence of an effective mechanism or point of attack or chemical, similarities with other known reproductive substances or other information from humans, which may conclude that such effects are likely to occur in humans. Where there are only studies of an animal species without other relevant supporting documents, classifications in Category Rep3 may be appropriate.
Since reproductive capability may appear as a non-specific knockdown effect of severe general toxicity or where there is serious collection, classification in Category Rep2 should be classified only if there is evidence of some degree of specific toxicity to the reproductive operation. If it has been demonstrated that reproductive efficiency in animal testing is due to dizzying parring, it will normally be necessary for the classification in Category Rep2 to have evidence of the reaction mechanism in question in order to be able to : interpret whether it is likely that any harmful effects, such as changes in the hormone balance, will also be held in people's places.
Development toxicity
In order to classify a substance in category Rep2, documentation must clearly indicate harmful effects from well-organised experiments with one or more animal species. Since harmful effects during pregnancy or after birth can be caused by secondary effects of maternel toxicity, the consumption of food or water, the stress of the mother animal, the shortage of juveninal care, specific deficiencies in the feed, poor breeding conditions, adjacent infections and so on, it is important that the observed effects appear during well-organised tests and at dose levels that are not associated with significant maternel toxicity. The method of application is also important. In particular, the intraperitonic venom of localising substances may cause local damage to the uterus and its contents, and the results of such investigations may be interpreted with prudence and would normally not only be able to lead to classification.
Classification in Category Rep3 based on similar criteria as for Category Rep2 but can be used where there are certain deficiencies in the design of the study, which may make the conclusions less convincing, or the possibility of the effects may be caused by : non-specific influences, such as general toxicity, cannot be excluded.
Generally speaking, classification is used in Category Rep3 or no category on an ad hoc basis, where the only observed effects are minor changes in the frequency of spontaneous defects, minor changes to the frequency of commonly occurring ; any variants observed in skeletal studies or small differences noted in the assessment of post-natal developments.
Effects during amusing
Substances which are classified as toxic to reproduction and which also give cause for concern as to their effects on the feeding must also be assigned to R64 (see the criteria in section 3.2.8).
In the case of the classification, toxic effects will be exclusively as a result of exposure to the milk or toxic effects that are one ; directly the exposure of children to the substance shall not be considered as 'toxic to reproduction', unless the effects result in the inhibited development of the offspring.
Substances which are not classified as toxic to reproduction but which cause concerns as a result of toxicity when transferred to infants under the ammex period must be marked with R64 (see criteria of 3.2.8.). This R-phrase may also be used for substances which affect the quantity or quality of the milk.
R64 is normally used on the basis of :
a)
toxicokinetic studies indicating that the substance may be present in possible toxic quantities in breast milk and / or
b)
on the basis of results from one or two-generation experiments involving animals indicating harmful effects of offspring resulting from transmission by the milk ; and / or
c)
on the basis of evidence from people who are indicative of a threat to infants in the framework of the ammetime.
Substances on which it is known that they accumulate in the body, and which can then be transmitted with milk under aamation, can be assigned to R33 and R64.
3.2.8.
Other toxicological properties
Substances and products classified according to section 2.2.1 to 3.2.7 or 3.3.1 to 3.3.6. or in accordance with section 4, additional R-phrases shall be assigned in accordance with the following criteria :
R29
Developer giftig gas when contact with water
Substances and products which, in contact with water or damp air, develop very toxic or toxic gases in potentially dangerous quantities, such as aluminium phosphid, phosphorous phosphate.
R31
Developer giftig gas when contact with acid
Substances and products that react with acid in the development of toxic gases in dangerous quantities, such as sodium hypochlorite, bariumpolysulphides. For substances for private use, S50 should not be mixed........ (if specified by the manufacturer)).
R32
Developer highly toxic gas when contact with acid
Substances and products which react with acid in the development of very toxic gases in dangerous quantities, e.g. salts of hydrogen cyanide, sodium oxide. For substances for private use, S50 should not be confused......... (if specified by the manufacturer)).
R33
Can accumulate in the body after repeated use
Substances and products likely to be accumulated in the human body and where this accumulation may cause concern, but not so much that it is justified to use R48.
On products containing substances with R33, see section 3.3.7.
R64
Can harm children in the sucka period
For substances and products which are collected by women and which may affect the breast or may be present (including metabolites) in the breast milk in sufficient quantities to be harmful to breast children.
With regard to comments on the application of this R-phrase (and in certain cases R33), reference is made to section 3.2.7.3.2.
On products containing substances with R64, see section 3.3.7.
R66
Repeated exposure may cause dry or cracked skin.
For substances and products that may cause concern because the skin is dry, scales of or cracks but which do not meet the criteria for R38 and shall be assigned either on the basis of :
a)
practical observing for normal handling and use, or
b)
relevant evidence concerning their prefixed effects on the skin.
The results from structure / activity relationships can also justify the allocation of the R66.
R67
Vacus can cause clockiness and dizziness.
For volatile substances and products containing clear symptoms of the weakening of the central nervous system during inhalation and which are not already classified with acute inhalation toxicity (R20, R23, R26, R68/20, R39/23 or R39/26)
The following documentation may be used
a)
Data on animal testing, which shows clear signs of weakening of the central nervous system, as narcotic effects, letariangi, failing coordination (including loss of 'wealth reflex', that is, the case of 'rigidity'. the reflex that leads the animal back to the creation of a position) and ataksi, either :
-WHAT?
at concentrations / exposure times of not more than 20 mg/l/4h, or,
-WHAT?
where the ratio between up to 4 hours and saturated steam concentration (SVC) at 20 ºC is less than or equal to 1/10.
b)
Practical experiences of human beings (e.g. narcosis, mortality, reduced attention, failing reflexes, vertigo coordination, vertigo) from well-documented reports under exposure conditions comparable to those specified above effects on animals.
Results from structure / activity relationships can also justify the allocation of R67.
Other additional R phrases are set out in 2.2.6.
For products containing one or more R67 substances, see section 3.3.7.
3.3.
Classification of products based on the classification of the incoming substances (calculation methods)
The classification of health-risk products for the calculation based on the classification of the incoming substances must be taken into account all the substances which are to be classified for health hazinas referred to in point 3.2, even if they are to : presence in the form of impurities, constituents or additives.
Without prejudice to lower concentration limits for the classification of the hazard, however, no account shall be taken of the substances present in a product in concentrations ;
Haunting of the substance
Concentration
gaseous gaseous
products
% vol / vol
others
products
% Weight / Weight
Meget giftig
0,02
0.0.1
Giftig
0,02
0.0.1
Carcinogenic Category 1 and 2
0,02
0.0.1
Mutagen Category 1 and 2
0,02
0.0.1
Toxic Categories 1 and 2
0,02
0.0.1
Harmful
0,2
≥ 1
Ate
0,02
≥ 1
Locator
0,2
≥ 1
Sensibilising
0,2
≥ 1
Carcinogenic Category 3
0,2
≥ 1
Mutagen Category 3
0,2
≥ 1
Toxic category 3
0,2
≥ 1
The concentration of a substance in a product is calculated for non-gaseous products as a percentage by weight and by gaseous products as a volume percentage.
The calculation methods are specified in 3.3.1. to 3.3.7, as well as for gaseous products listed in 3.3.8.
When it can be established that calculation methods, because of effects such as potensation or antagonism, lead to an under-or overvaluing of the health risks of the product, these effects must be taken into account when the product classification is. This is true that the substances which cause that effect should be classified as dangerous or not.
3.3.1.
Acute lethal effects
In calculating the classification of products due to their acute lethal effects, the content substances that meet the classification criteria as highly toxic or toxic or harmful due to such effects are taken into account, cf. item 3.2.1. However, this does not apply to the content substances that are classified as harmful to R65. On the classification of products such as hazardous to health, due to their ability to induce chemical pneumonia, see the criterion for R65, item 3.2.1.3.
3.3.1.1.
If only such a substance, in the product, the classification of the product is shown in the following table. 8)
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances is set out other concentration limits.
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
The applicable phrase (s) of the product shall correspond to the R-statement of the substance (s) of the substance.
Classification of the substance
Tx with R26,
T with R23,
Xn with R20,
Concentration
(weight percentage) of the substance in the product
R27 and / or R28
R24 and / or R25
R21 and / or R22
0% ≤ konc. < 0,1%
0,1% ≤ conc. < 1%
Xn with R20, R21 and / or R22
1% ≤ conc. < 3%
T with R23, R24 and / or R25
3% ≤ konc. < 7%
Xn with R20, R21 and / or R22
7% ≤ konc. < 25%
Tx with R26, R27 and / or R28
25% ≤ konc.
T with R23, R24 and / or R25
Xn with R20, R21 and / or R22
3.3.1.2.
If, in the product, more than one substance, classified according to section 3.2.1, the classification of the product shall be calculated according to the following criteria : the product is assigned the hazard symbol, the indication of danger and the phrase (s) of the phrase (s) corresponding to the classification of the product.
In the case of the route of entry, R-phrases shall reflect the dangers of the product on the classification of the incoming substances. Where one or more substances are included in a concentration which in itself would lead to classification according to section 3.3.1.1, the product must be given at least R-Phrase (s) which shall correspond to the classification of this product or the classification of the substances.
3.3.1.2.1.
Product is classified as highly poisonous if the sum of the figures resulting from the concentration of each highly toxic substance in the product with the concentration limit for this substance for the classification as highly toxic is greater than or equal to 1, i.e. :
AL2280_15_2.png Size : (64 X 34)
where
P Tx the concentration of each highly toxic substance in the product, and
L Tx the concentration limit for the product classification as highly toxic for each highly toxic substance in the product.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as highly toxic is used the following value : 8) :
L Tx : 7%
3.3.1.2.2.
Product is classified as giftig if the sum of the figures resulting from the concentration of each highly toxic or toxic substance in the product with the concentration limit for this substance for the classification as toxic, is greater than or equal to 1, i.e. :
AL2280_15_3.png Size : (111 x 36)
where
P Tx and P T is the concentration of each of the toxic and toxic substances in the product, and
L TxT and L T-T the concentration limit for the classification of the product as toxic for each of the toxic and toxic substances in the product is toxic.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification is fixed as toxic is used the following values : 8) :
L TxT : 1%
L T-T : 25%
3.3.1.2.3.
Product is classified as harmful to health, if the sum of the figures resulting from the concentration of each very toxic, toxic or harmful substances-with the exception of substances awarded to the R65-in the product, with the exception of this substance for the concentration limit for this substance, the amount of the substances which have been allocated for the concentration limit for this substance shall be subject to : classification as harmful to health, is greater than or equal to 1, i.e. :
AL2280_15_4.png Size : (164 X 36)
where
P Tx , P T and P Xn the concentration of each of the toxic, toxic and harmful substances in the product is used, and
L Tx-Xn YOU'RE NOT T-Xn and L Xn-Xn the concentration limits for the classification of the product are harmful to the health damage of each of the toxic, toxic and harmful substances, except for the R65, with the R65 substances, in the product.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as harmful to health is subject to the following values : 8) :
L Tx-Xn : 0,1%
L T-Xn : 3%
L Xn-Xn : 25%
3.3.2.
Non-lethal, but irreversible damage after a single exposure.
For the purposes of calculating the classification of products on account of their non-lethal, but irreversible effects after a single exposure, the substance is taken into consideration which meets the criteria for classification as a result of such exposure ; effects, cf. item 3.2.2.
The classification of the product is apparent from the following schema 8) , since each substance is to be considered.
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances has been set at a different concentration limit.
The product shall be assigned the symbol of danger, the indication of danger and the phrase of the R-statement corresponding to the classification. In order to specify the injections / impact, combinations of R-phrases shall be used in accordance with the requirements referred to in section 3.2.2. specified.
Classification of the substance
Tx with R39
T with R39
Xn with R68
Concentration (weight percent) of the substance in the product
0% ≤ konc. < 0,1%
0,1% ≤ conc. < 1%
Xn with R68
1% ≤ conc. < 10%
T with R39
Xn with R68
10% ≤ konc.
Tx with R39
T with R39
Xn with R68
3.3.3.
Serious adverse effects on repeated or prolonged exposure.
For the purposes of calculating the classification of products due to their serious adverse effects on repeated or prolonged exposure, the content substances that meet the classification criteria as a result of such effects, cf. item 3.2.3.
The classification of the product is apparent from the following schema 8) , since each substance is to be considered.
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances has been set at a different concentration limit.
The product shall be assigned the symbol of danger, the indication of danger and the phrase of the R-statement corresponding to the classification. To specify the injectable / impact method combinations of R-phrases are used in accordance with the procedure laid down in 3.2.3. specified.
Classification of the substance
T with R48
Xn with R48
Concentration (weight percent) of the substance in the product
0% ≤ konc. < 1%
1% ≤ conc. < 10%
Xn with R48
10% ≤ konc.
T with R48
Xn with R48
3.3.4.
Agrating and irritant effects
For the purposes of calculating the classification of products on the basis of their corrosive and irritant effects, the content substances that meet the classification criteria as a result of such effects shall be taken into account as defined in the case of such effects, cf. item 3.2.5.
For the classification according to calculation rules, the recommendations shall be taken into account in section 3.2.5.1, 3. point and section 3.3 for potent and antagonism.
3.3.4.1.
If there is only such a substance, in the product, the classification of the following table shows : 8) :
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances has been set at a different concentration limit.
The product shall be assigned the symbol of danger, the indication of danger and the phrase of the R-statement corresponding to the classification.
Classification of the substance
C with R35
C with R34
Xi with R41
Xi with R36,
Concentration (weight percent) of the substance in the product
R37 and / or R38
0% ≤ konc. < 1%
1% ≤ conc. < 5%
Xi with R36/38
5% ≤ konc. < 10%
C with R34
Xi with R36/38
Xi with R36
10% ≤ konc. < 20%
C with R35
C with R34
Xi with R41
20% ≤ konc.
Xi with R36, R37 and / or R38
3.3.4.2.
If, in the product, more than one substance, have been classified according to section 3.2.5, the classification of the product according to the following criteria, given the danger symbol, the indication of danger and the phrase (s) of the phrase (s) corresponding to the classification.
3.3.4.2.1.
Product is classified as corrosive to R35, if the sum of the figures resulting from the concentration of each substance in the product that is classified as corrosive to the concentration limit for the classification as corrosive to that substance as corrosive to R35 is greater than or equal to 1, i.e. :
AL2280_15_5.png Size : (69 X 35)
where
P R35 is the concentration of each substance in the product that is classified as corrosive to R35, and
L R35 the concentration limits for the product classification as corrosive to each substance in the product, which is classified as corrosive to R35, is the concentration limit.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as corrosive to R35 shall be the following value : 8) :
L R35 : 10%
3.3.4.2.2.
Product is classified as corrosive to R34, if the sum of the figures resulting from the concentration of each substance in the product that is classified as corrosive to R35 or corrosive to R34 with the concentration for this substance for the classification as corrosive to R34 shall be so as corroborated ; is greater than or equal to 1, i.e. :
AL2280_15_6.png Size : (136 X 37)
where
P R35 and P R34 the concentration of each substance in the product, which is classified as corrosive to R35 and corrosive to R34, and
L R35-R34 and L R34-R34 the concentration limit for the product classification as corrosive to R34 for each substance in the product, which is classified as corrosive to R35 and corrosive, is equivalent to R34 and corrosive.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as corrosive to R34 shall be used for the following values : 8) :
L R35-R34 : 5%
L R34-R34 : 10%
3.3.4.2.3.
Product is classified as irritant to R41, if the sum of the figures resulting from the concentration of each substance in the product that is classified as irritant with R41 or as corrosive, with the concentration limit for this substance for the classification as defined as &quot; the &quot;, irritant with R41, is greater than or equal to 1, i.e. :
AL2280_15_7.png Size : (188 X 36)
where
P R35 , P R34 and P R41 is the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34 and irritant to R41, and
L R35-R41 , and L R34-R41 and L R41-R41 the concentration limit for the product classification as a irritant to R41 for each substance in the product, which is classified as corrosive to R35, corrosive to R34 and irritant with R41.
Unless, for a substance in the list of dangerous substances, a different classification limit for classification as irritant with R41 is the following values : 8) :
L R35-R41 : 5%
L R34-R41 : 10%
L R41-R41 : 10%
3.3.4.2.4.
Product is classified as irritant with R38 9) , if the sum of the figures resulting from the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34 or irritant with R38 with the concentration limit for this substance for the concentration of the substance, classification as irritant with R38, is greater than or equal to 1, i.e. :
AL2280_15_8.png Size : (190 X 36)
where
P R35 , P R34 and P R38 is the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34 and irritant with R38 and
L R35-R38 YOU'RE NOT R34-R38 and L R38-R38 the concentration limit for the product classification as irritant with R38 for each substance in the product, which is classified as corrosive to R35, corrosive to R34 and irritant with R38. Unless, for a substance in the list of hazardous substances, a different classification limit for classification as irritant with R38 is used for the following values : 8) :
L R35-R38 : 1%
L R34-R38 : 5%
L R38-R38 : 20%
3.3.4.2.5.
The product shall be classified as irritant to R36 if the sum of the figures resulting from the concentration of each substance in the product that is classified as irritant with R41 or irritant with R36 or as corrosive to the product ; the concentration limit for this substance for classification as irritant with R36 is greater than or equal to 1, i.e. :
AL2280_15_9.png Size : (242 X 36)
where
PR35, PR34, PR41, and PR36 are the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34, irritant with R41 and irritant with R36, and
LR35-R36, LR34-R36, LR41-R36 and LR36-R36 are the concentration limits for the product classification as irritant with R36 for each substance classified as corrosive to R35, corrosive to R34, irritant with R41 and irritating with R36.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as irritant with R36 is used as the following values8) :
LR35-R36 : 1%
LR34-R36 : 5%
LR41-R36 : 5%
LR36-R36 : 20%
3.3.4.2.6.
The product shall be classified as irritant to R37 if the sum of the figures resulting from the concentration of each substance in the product that is classified as irritant with R37, with the applicable for this substance, the rating limit for classification as irritant with R37 is greater than or equal to 1, i.e. :
AL2280_15_10.png Size : (71 X 36)
where
PR37 is the concentration of each substance in the product that is classified as irritant with R37 and
LR37 is the concentration limits of the product classification as irritant to R37 for each substance in the product that is classified as irritant to R37.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as irritant with R37 shall be used as the following value 8 (8)) :
LR37 : 20%
3.3.4.2.7.
A gaseous product shall be classified as irritant with R37 if the sum of the figures resulting from the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34 or irritant with R37 is corrosive ; the concentration limit for this substance for classification as irritant with R37 shall be greater than or equal to 1, i.e. :
AL2280_15_11.png Size : (194 X 35)
where
PR35, PR34 and PR37 are the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34 and irritant with R37 and
LR35-R37, LR34-R37 and LR37-R37 are the concentration limits for the product classification as irritant with R37 for each substance, classified as corrosive to R35, corrosive to R34 and irritant with R37. Unless, for a substance in the list of hazardous substances, a different classification limit for classification as irritant with R37 shall be used as follows :
LR35-R37 : 0,02%
LR34-R37 : 0,5%
LR37-R37 : 5%
3.3.5.
Sensitizing effects
For the purposes of calculating the classification of products due to their sensitizing effects, the content substances that meet the classification criteria for such effects shall be taken into account, cf. item 3.2.6. The classification of the product is apparent from the following table 8), since each substance is to be considered to be.
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances has been set at a different concentration limit.
The product shall be assigned the symbol of danger, the indication of danger and the phrase of the R-statement corresponding to the classification.
If the product is both to be classified with R42 and R43, the combination of R42/43 is used.
Classification of the substance
Sensitizing with R42
Sensitizing with R43
Concentration (weight percent) of the substance in the product
0% ≤ konc. < 1%
1% ≤ conc.
Sensitizing with R42 (This hazard symbol and
-designation Xn
Sensitizing with R43 (hazard symbol and
-designation Xi
3.3.6.
Carcinogens, mutagenic and toxic effects
If a chemical product contains one or more substances that meet the classification criteria as carcinogenic, mutagen or reproductive toxicity, cf. in section 3.2.7, the product has to be classified in the same way as the substance (substances), where the concentration of the substance (substances) is greater than or equal to the concentration limits of the below. 5) .
Each substance and every property to which the substance is classified shall be considered to be.
Carcinogenic chemical products in category Carc3 shall not be marked with R40 if the R45 has already been assigned. If the product is to be allocated both R49 and R40, then both R-phrases must be specified because R40 does not take up the exposure route, while R49 applies only in case of inhalation.
Mutagenical chemical products in category Mut3 shall not be labelled with R68 if R46 has already been allocated.
Toxic chemical products in Category Rep3 must not be labelled with R63, if R61 has already been allocated.
Concentration limits for the classification of products as carcinogenic, mutagenic and toxic to reproduction :
Classification of the substance
Concentration Limit (% weight by weight)
carcinogenic, category Carc1 and Carc2
(T with R45 or R49)
0,1%
carcinogenic, category Carc3 ;
(Xn with R40)
1%
mutagen, category Mut1 and Mut2 ;
(T with R46)
0,1%
mutagen, category Mut3 (Xn with R68)
1%
reproduction toxicity, category Rep1 and Rep2 (T with R60 and / or R61)
0.5%
reproduction toxicity, category Rep3 (Xn with R62 and / or R63)
5%
These concentration limits shall apply, except where the substance in question in the list of hazardous substances has been set at a different concentration limit for the effect in question.
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
3.3.7.
Other toxicological properties
It must be assessed in accordance with the criteria set out in section 3.2.8, whether a product should be allocated to the additional R-phrases R29, R31, R32 and R66.
For products classified in accordance with the above points 2.2.1. -3.2.7. or 3.3.1. -3.3.6 and which contain one or more substances classified with R33 or R64 the product is classified by R33, respectively R64, if the substance of the product is included in the product in a concentration of 1% or more, unless there is set a different concentration limit in the list of hazardous substances.
3.3.8.
Gas-mixing products (gas mixtures)
In the case of gaseous products, the classification limits for classification other than those specified in section 3.3.1 are applicable to 3.3.6. Instead of the scheme, item 3.3.1.1. the following applies :
Classification of the substance
Tx with R26, R27
T with R23, R24
Xn with R20, R21
Concentration (Volume Percent) of the substance in the product
and R28
and R25
and R22
0% ≤ konc. < 0,02%
0.02% ≤ conc. < 0,2%
Xn with R20, R21 and / or R22
0,2% ≤ conc. < 0,5%
T with R23, R24 and / or R25
0.5% ≤ conc. < 1%
Xn with R20, R21 and / or R22
1% ≤ conc. < 5%
Tx with R26, R27 and / or R28
5% ≤ konc.
T with R23, R24 and / or R25
Xn with R20, R21 and / or R22
Instead of the limits that exist in item 3.3.1.2. the following applies :
L Tx : 1%
L TxT : 0,2%
L T-T : 5%
L Tx-Xn : 0,02%
L T-Xn : 0.5%
L Xn-Xn : 5%
Instead of the scheme, section 3.3.2 shall be as follows :
Classification of the substance
Tx with R39
T with R39
Xn with R68
Concentration (Volume Percent) of the substance in the product
0% ≤ konc. < 0,02%
0.02% ≤ conc. < 0,2%
Xn with R68
0,2% ≤ conc. < 0,5%
T with R39
0.5% ≤ conc. < 1%
Xn with R68
1% ≤ conc. < 5%
Tx with R39
5% ≤ konc.
T with R39
Xn with R68
Instead of the scheme, item 3.3.3. the following applies :
Classification of the substance
T with R48
Xn with R48
Concentration (Volume Percent) of the substance in the product
0% ≤ konc. < 0,5%
0.5% ≤ conc. < 5%
Xn with R48
5% ≤ konc.
T with R48
Xn with R48
Instead of the scheme, item 3.3.4.1. the following applies :
Classification of the substance
C with R35
C with R34
Xi with R41
Xi with R36, R37
Concentration (Volume Percent) of the substance in the product
and / or 38
0% ≤ konc. < 0,02%
0.02% ≤ conc. < 0,2%
Xi with R36, R37 and / or R38
0,2% ≤ conc. < 0,5%
C with R34
0.5% ≤ conc. < 1%
Xi with R36,
Xi with R36
R37 and / or R38
1% ≤ conc. < 5%
Xi with R36,
5% ≤ konc.
C with R35
C with R34
Xi with R41
R37 and / or R38
Instead of the limits that exist in item 3.3.4.2. the following applies :
L R35 : 1%
L R35-R34 : 0,2%
L R34-R34 : 5%
L R35-R41 : 0,2%
L R34-R41 : 5%
L R41-R41 : 5%
L R35-R38 : 0,02%
L R34-R38 : 0.5%
L R38-R38 : 5%
L R35-R36 : 0,02%
L R34-R36 : 0.5%
L R41-R36 : 0.5%
L R36-R36 : 5%
L R37 : 5%
Instead of the scheme, section 3.3.5. the following applies :
Classification of the substance
Sensitizing with R42
Sensitizing with R43
Concentration (Volume Percent) of the substance in the product
0% ≤ konc. < 0,2%
0,2% ≤ conc.
Sensitizing with R42 (This hazard symbol and description Xn)
Sensitizing with R43 (hazard symbol and description Xi)
Instead of the scheme, section 3.3.6 shall be as follows :
Classification of the substance
Concentration Limit (Volume Percent)
carcinogenic, category Carc1 and Carc2
(T with R45 or R49)
0,1%
carcinogenic, category Carc3 ;
(Xn with R40)
1%
mutagen, category Mut1 and Mut2 ;
(T with R46)
0,1%
mutagen, category Mut3
(Xn with R68)
1%
reproduction toxicity, category Rep1 and Rep2 ;
(T with R60 and / or R61)
0.2%
reproduction toxicity, category Rep3
(Xn with R62 and / or R63)
1%
4.
CLASSIFICATION FOR ENVIRONMENTAL EFFECTS
4.1.
Introduction
The main purpose of classifying substances dangerous to the environment is to warn the user against the dangers that these substances pose to the ecosystems. The current criteria are mainly referring to the aquatic environment, but some substances may at the same time or, instead, have effects on other ecosystems with populations that can extend from the soil microphases of the soil and microfauna to mammals. The criteria set out below shall be followed directly by Commission Regulation (EC) No 2. 440/2008 of 30. May 2008 laying down experimental methods in accordance with Regulation (EC) No 2 of the European Parliament and of the Council. 1907/2006 on the registration, assessment and approval, as well as restrictions on chemicals (REACH), to the extent that they have been mentioned. The test methods for the base set referred to in Annexes VII and VIII to Regulation (EC) No (EC) No 1907/2006 is limited, and the information from here may be insufficient for the appropriate classification. A classification may require additional data on the basis of Annexes IX and X to Regulation (EC) No 2. 1907/2006 or other similar studies. Classifications may also be re-examined in the light of new knowledge.
For the purposes of classification, the criteria on the basis of the present knowledge in two groups shall be either after the acute and / or long-term effects of the substances in the aquatic environment or the acute and / or long-term effects of the substances in other ecosystems.
Substances shall be classified on the basis of the fact-finding data available in accordance with the criteria referred to in 4.2.
For products, classification shall be classified as follows :
For acute aquatic toxicity :
a)
on the basis of the classification of the incoming substances, by using the calculation methods in Point 4.3.
b)
according to the criteria referred to in 4.2. The properties are determined by means of the methods set out in Annex 12 with less for plant protection products other internationally accepted methods are acceptable in accordance with the publication of the control measures laid down in Annex 5.1. At the same time, for plant protection products, the test requirements must comply with Annex 5.1. in the fight against the mean publication.
If a toxicological property is determined both from the rules of a (a) and (b), the results of point (b) shall be used for the classification of the product, with the exception of undesirable long-term effects and hazards for the ozone layer, where the calculation methods laid down in Point 4.3 must be taken ; used.
Where the methods of paragraph (b) apply, the quality criteria for the methods set out in Annex 12 must be complied with The samples must also be carried out on all three species groups in accordance with the criteria referred to in 4.2. (algae, daphnia and fish), unless the product has been assigned the highest peril of exposure to the aquatic environment after testing on one of the species, or a result of the test already existed before this notice ; entered into force unless special rules are applied to plant protection products.
If one or more dangerous environmental properties of a product of known composition are evaluated based on fact-finding data, other than plant protection products must take a new evaluation, either based on the examination data or by using the calculation method in the following cases :
1. If changes are made to the composition of the product by replacing or inserting one or more substances, whether these substances are to be classified as dangerous or not,
2. the concentration of one of the substances classified as classified for the environment is changed. However, a new assessment does not need to be re-evaluated if the concentration of the concentration does not exceed the following limits :
Interval of the initial concentration of the substance
Allowed variation in the initial concentration of the substance (as a percentage of the initial concentration)
2.2.5%,
± 30%
> 2.510%, 10%
± 20%
> 10 25%
± 10%
> 25 100% 100%
± 5%
The new assessment shall be valid unless there are scientific reasons to assume that a review of the danger is not going to result in a change of classification.
4.2.
Criteria for classification based on survey data
4.2.1.
Aquatic environment
4.2.1.1.
Substances shall be classified as dangerous for the environment and assigned the symbol &quot; N &quot;, the indication of danger as &quot; dangerous to the environment &quot; as well as R-phrases according to the following criteria :
4.2.1.1.1.
Both the following R phrases :
R50 Very toxic to organisms living in water
and
R53 May cause undesirable long-term effects in the aquatic environment
Acute Toxicity :
96 hours LC 50 (for fish) ≤ 1 mg/l or
48 Hours EC 50 (for Daphnia) ≤ l / l or
72 hours EC 50 (foralgae) ≤ 1 mg/l,
and
the substance is not readily biodegradable or log P ow. (log octanol / water partition coefficient), 3,0 (unless the experimental bioconcentration factor (BCF) ≤ 100) is not used.
4.2.1.1.2.
Both of the following R phrases
R51 Toxic to organisms living in water
and
R53 May cause undesirable long-term effects in the aquatic environment
Acute Toxicity :
96 hours LC 50 (for fish) 1 mg/l < LC 50 ≤ 10 mg/l or
48 Hours EC 50 (for Daphnia) I mg/1 < EC 50 ≤ 10 mg/l or
72 hours EC 50 (for algae) l mg / l < IC 50 ≤ 10 mg/l
and
the substance is not readily biodegradable or log P ow. (log octanol / water partition coefficient), 3,0 (unless the experimental bioconcentration factor (BCF) ≤ 100) is not used.
4.2.1.1.3.
Substances and products are classified as dangerous to the environment and assigned the symbol &quot; N &quot;, the indication of danger as &quot; dangerous goods &quot; and the R-sentence according to the following criteria :
R50 Very toxic to organisms living in water
Acute Toxicity :
96 hours LC 50 (for fish) ≤ 1 mg/l or
48 Hours EC 50 (for dnia) ≤ l mg/1 or
72 hours EC 50 (for algae) ≤ l mg/l,
4.2.1.2.
Substances shall also be classified as environmentally hazardous and assigned R-phrases according to the following criteria :
4.2.1.2.1.
Both of the following R phrases
R52 Harmful for organisms living in water
and
R53 May cause undesirable long-term effects in the aquatic environment
Acute Toxicity :
96 hours LC 50 (for fish) 10 mg/l < LC 50 ≤ 100 mg/l or
48 Hours EC 50 (for daphnia) l0 mg/1 < EC 50 ≤ 100 mg/l or
72 hours EC 50 (for algae) l0 mg/l < IC 50 ≤ 100 mg/l
and
the substance is not readily biodegradable.
This criterion shall apply unless there is sufficient scientific evidence of the degradation and / or toxicity of the substance to with reasonable certainty that neither the substance nor its degradation products constitute any potential ; long-term and / or delayed environmental haz-risk.
Such additional scientific evidence should normally be based on studies required in accordance with Annex IX to Regulation (EC) No 2 of the European Parliament and of the Council. 1907/2006 on the registration, assessment and approval of and restrictions on chemicals (REACH) or studies of equivalent value and could include :
i)
a proven possibility of rapid decomposition in the aquatic environment ;
(ii)
lack of chronic toxic effects at a concentration of 1,0 mg/l, e.g. no observed effect at concentrations of 1,0 mg/l determined by prolonged toxicity study with fish or daphnia.
4.2.1.2.2.
R53 May cause undesirable long-term effects in the aquatic environment
Substances which do not fall within the criteria referred to in points 4.2.1.1 and 4.2.1.2, but which, on the basis of the evidence available for their persistence, accumulation potential and their foreseen or observed fate and behaviour in the environment, may, however, constitute an immediate or long-term and / or delayed hazard of the structure and / or function of the ecosystem systems.
For example, substances with low water solubility, d.v.s. substances with a solubility of less than 1 mg/l shall be subject to this criterion if :
a)
they are not easily degradable and
b)
log P ow. (log octanol / water partition coefficient), 3,0 (unless the experimental bioconcentration factor (BCF) ≤ 100) is not used.
This criterion shall apply unless there is sufficient scientific evidence of the degradation and / or toxicity of the substance to with reasonable certainty that neither the substance nor its degradation products constitute any potential ; long-term and / or delayed environmental haz-risk.
Such additional scientific evidence should normally be based on studies required in accordance with Annex IX to Regulation (EC) No 2 of the European Parliament and of the Council. 1907/2006 on the registration, assessment and approval of and restrictions on chemicals (REACH) or studies of equivalent value and could include :
i)
a proven possibility of rapid decomposition in the aquatic environment ;
(ii)
lack of chronic toxic effects at a concentration of 1,0 mg/l, e.g. no observed effect at concentrations of 1,0 mg/l determined by prolonged toxicity study with fish or daphnia.
4.2.1.3.
Substances and products are also classified as dangerous for the environment and assigned the R-statement according to the following criteria :
R52 Harmful for organisms living in water
Substances which do not fall within the criteria referred to in points 4.2.1.1 and 4.2.1.2, and products not to be classified as highly toxic or toxic to the aquatic environment, but which on the basis of the evidence available for their toxicity, may nevertheless constitute a hazard to the structure and / or function of the water ecosystem.
4.2.1.4.
For the purpose of applying the criteria set out in Section 4.2.1.1 to 4.2.1.3 :
Where it is demonstrated in the case of highly coloured substances or products, that the algeal growth is prevented solely from limited lymph intensity, the classification base should not be 72 hours of EC ; 50 algae.
Substances shall be deemed to be readily degradable where the following criteria are met :
a)
If biodegradability studies more than 28 days are obtained, the following degradation levels are obtained :
-in studies based on dissolved carbon : 70%,
-in studies based on oxygenre consumption or production of carbon dioxide : 60% of the theoretical maximum.
These biodegradation levels shall be attained within 10 days from the start of decomposition, at which time is calculated at the time 10% of the substance has been broken ; or
b)
Provided only COD or BOD is available ; 5 -data when the BOD/COD ratio is greater than or equal to 0,5, or
c)
In the case of other compelling scientific evidence that the substance can be degraded (biodegradability and / or otherwise) in the aquatic environment to a level of over 70% over a period of 28 days.
4.2.2.
Other ecosystems other than the aquatic environment
4.2.2.1.
Substances shall be classified as dangerous for the environment and assigned the symbol &quot; N &quot;, the indication of danger as &quot; dangerous to the environment &quot;, and at least one of the following R phrases according to the following criteria :
R54 Toxic to plants
R55 Toxic to animals
R56 Toxic to grounders in soil
R57 Toxic to bees
R58 May cause undesirable long-term effects in the environment
Substances which, on the basis of the present evidence of their properties, persistence, accumulation potential and their foreseen or observed fate and behaviour in the environment, may constitute an immediate or long-term and / or delayed danger ; the structure and / or function of other natural ecosystems other than those covered by point 4.2.1. (Whether or not these substances are classified according to 4.2.1). Detailed criteria will be drawn up later.
4.2.2.1
The ozone layer
Substances shall be classified as dangerous for the environment and assigned the symbol &quot; N &quot;, the indication of danger as &quot; Dangerous Dangerous ' and R-phrases according to the following criteria :
R59 Dangerous for the ozone layer
Substances which, on the basis of the present evidence of their properties and their foreseen or observed fate and behaviour in the environment, may constitute a danger to the structure and / or function of the ozone layer in the stratosphere. This includes substances listed in Annex I of Council Regulation (EC) No 2. 2037/2000 on substances that deplet the ozone layer (FT-L 244 of 29.9.2000, p. 1) with subsequent amendments.
4.3.
Classification of products based on the classification of the incoming substances (the calculation method)
For the classification of environmental haz-risk products, account must be taken of all the content substances which are to be classified for environmental risk in accordance with point 4.2, even if they are present in the the form of impurities, constituents or additives.
Without prejudice to lower concentration limits for the classification of the hazard, however, no account shall be taken of the substances present in a product in concentrations ;
Haunting of the substance
Concentration
Gasformige% vol ./vol.
Other% Weight / Weight
Dangerous, N
0,1%
Dangerous, ozone
0,1%
0,1%
Environmental Dangerous
1%
The calculation methods are specified in 4.3.1 to 4.3.5.1.
4.3.1.
Acute toxicity and adverse long-term effects on the aquatic environment
For the purposes of calculating the classification of products, due to their acute toxicity and long-term adverse effects on the aquatic environment, the content substances which meet the criteria for the classification of such effects shall be taken into consideration.
4.3.1.1.
If only one such substance in the product, the classification of the product is shown in the following table.
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances is set out other concentration limits.
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
Classification of the substance
N with R51/53
R52/53
Concentration
(weight percentage)
the substance of the product,
0% ≤ konc. < 2,5%
2,5 %≤ konc. < 25%
R52/53
25% ≤ konc.
N with R51/53
R52/53
4.3.1.2.
If only one such substance classified as N with R50/53 of the product, is shown in the classification of the product by the following schema.
Concentration limits (C n () in the scheme, except where the substance in the list of hazardous substances in the list is specified, other concentration limits have been set. For products containing a LC 50 -value or EC 50 -value less than 0,00001 mg/l, the concentration limits are calculated in a similar manner (at a factor of 10 intervals).
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
LC 50 -or EC 50 -value
Classification of the product
(L (E) C 50 () for substance classified
N, R50/53
N, R51/53
R52/53
as N, R50/53 (mg/l)
0.1 < L (E) C 50 ≤ 1
C n 250%
2,5% ≤ C n < 25%
0.25% ≤ C n < 2,5%
0,01 < L (E) C 50 ≤ 0,1
C n 2,5%
0.25% ≤ C n < 2,5%
0.025% ≤ C n < 0,25%
0,001 < L (E) C 50 ≤ 0,01
C n ECU 0.25%
0.025% ≤ C n < 0,25%
0.0025% ≤ C n < 0,025%
0,0001 < L (E) C 50 ≤ 0,001
C n ECU 0.025%
0.0025% ≤ C n < 0,025%
0,00025% ≤ C n < 0,0025%
0.00001 < L (E) C 50 ≤ 0,0001
C n ECU 0.0025%
0,00025% ≤ C n < 0,0025%
0.000025% ≤ C n < 0,00025%
4.3.1.3.
If, in the product, more than one substance where the product is classified according to section 4.2, the classification of the product shall be calculated according to the following criteria, given the danger symbol, the indication of danger and the phrase (s) which correspond to the classification of the product.
4.3.1.3.1.
The product shall be classified as dangerous for the environment, with the danger symbol N and R50/53 if the sum of the figures resulting from the concentration of each N, R50/53 substance in the product with the concentration limit laid down for this substance for the classification as defined as : environmental hazard with N, R50/53 is greater than or equal to 1, i.e. :
AL2280_15_12.png Size : (113 X 40)
where
P N, R50/53 the concentration of each substance in the product with N, R50/53, and L, N, R50/53 the concentration limit for classification as environmentally hazardous to N, R50/53 for each such substance in the product.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to N, R50/53 is the following value :
L N, R50/53 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -classification as N, R50/53 is set out in Section 4.3.1.2.
4.3.1.3.2.
The product is classified as environmentally hazardous to N, R51/53, if the sum of the figures resulting from the concentration of each N, R50/53 or N, R51/53 substances in the product with the concentration limit for the classification as defined for this substance, N, R51/53, is greater than or equal to 1, i.e. :
AL2280_15_13.png Size : (243 X 37)
where
P N, R50/53 and P N, R51/53 the concentration of each of N, R50/53 and N, R51/53 substances in the product, and
L N, R50/53-N, R51/53 and L N, R51/53-N, R51/53 the concentration limits for the classification of the product as environmentally hazardous to N, R51 for each substance in the product, classified as environmental hazardous to N, R50/53 and N, R51/53 shall be classified as respectively.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to N, R51/53 is the following :
L N, R50/53-N, R51/53 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -classification as N, R51/53 is set out in Section 4.3.1.2.
L N, R51/53-N, R51/53 : 25%
4.3.1.3.3.
The product shall be classified as environmentally hazardous to R52/53 if the sum of the figures resulting from the concentration of each N, R5 0 / 53, N, R51/53 or R52/53 substances in the product with the concentration limit for the classification of this substance for the classification of the product on the substance, as R52/53, greater than or equal to 1, i.e. :
AL2280_15_14.png Size : (272 X 37)
where
P N, R50/53 , P N, R51/53 and P R52/53 the concentration of each of N, R5 0 / 53, N, R51/53 and R52/53 substances in the product, and
L N, R50/53-R52/53 YOU'RE NOT N, R51/53R52/53 and L R52/53R52/53 the concentration limits for classification as environmentally hazardous to R52/53 for each substance in the product, classified as environmentally hazardous to N, R5 0 / 53, N, R51/53 and R52/53 shall be classified.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to R52/53 is used as the following value :
L N, R50/53-R52/53 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -the classification as R52/53 is set out in Section 4.3.1.2.
L N, R51/53R52/53 : 2,5%
L R52/53R52/53 : 25%
4.3.2.
Acute aquatic toxicity
For the purposes of calculating the classification of products, due to their acute toxicity to the aquatic environment, the content substances that meet the classification criteria as a result of such effects shall be taken into account.
4.3.2.1.
If only one such substance classified as N with R50 in the product, classifies the classification of the product by the following schema.
Concentration limits (C n () in the scheme, except where the substance in the list of hazardous substances in the list is specified, other concentration limits have been set. For products containing a LC 50 -value or EC 50 -value less than 0,00001 mg/l, the concentration limits are calculated in a similar manner (at a factor of 10 intervals).
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
LC 50 -or EC 50 -value (L (E) C 50 () for substance classified as N, R50 (mg/l),
Classification of the product N, R50
0.1 < L (E) C 50 ≤ 1
C n 250%
0,01 < L (E) C 50 ≤ 0,1
C n 2,5%
0,001 < L (E) C 50 ≤ 0,01
C n ECU 0.25%
0,0001 < L (E) C 50 ≤ 0,001
C n ECU 0.025%
0.00001 < L (E) C 50 ≤ 0,0001
C n ECU 0.0025%
4.3.2.2.
If only one such substance classified as R52 in the product, the following table shows the classification of the product of the following table. The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances is set out other concentration limits.
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
Classification of the substance
R52
Concentration
(weight percentage)
the substance of the product,
0% ≤ konc. < 25%
25% ≤ konc.
R52
4.3.2.3.
If, in the product, more than one substance where the product is classified according to section 4.2, the classification of the product shall be calculated according to the following criteria, given the danger symbol, the indication of danger and the phrase (s) which correspond to the classification of the product.
4.3.2.3.1.
The product shall be classified as dangerous for the environment at the risk symbol N and R50 if the sum of the figures resulting from the concentration of each N, the R50 substance in the product with the concentration limit for the classification as defined for this substance, shall be classified as : environmental hazard with N, R50, is greater than or equal to 1, i.e. :
AL2280_15_15.png Size : (76 X 33)
where
P N, R50 is the concentration of each substance in the product with N, R50, and
L N, R50 the concentration limit for the product classification as environmentally hazardous to N, R50 for each such substance in the product.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to N, R50 is the following value :
L N, R50 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -classification as N, R50 has been set under point 4.3.2.1.
4.3.2.3.2.
The product shall be classified as environmentally hazardous with N, R50 if the sum of the figures resulting from the concentration of each N, R50 or N, R50/53 substance in the product with the concentration limit for the classification as defined for this substance for the classification as such environmental hazard with N, R50, is greater than or equal to 1, i.e. :
AL2280_15_16.png Size : (178 X 37)
where
P N, R50 and P N, R50/53 the concentration of each of N, R50 and N, R50/53 substances in the product, and
L N, R50-N, R50 and L N, R50/53-N, R50 the concentration limits for the classification of the product as environmentally hazardous to N, R50 for each substance in the product, classified as environmentally hazardous to R50 and environmentally hazardous with R50/53 shall be classified as appropriate.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to N, R50 is the following value :
L N, R50-N, R50 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -classification as N, R50 has been set under point 4.3.2.1.
L N, R50/53-N, R50 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -classification as N, R50 is determined under item 4.3.1.2.
4.3.2.3.3.
The product shall be classified as environmentally hazardous to R52 if the sum of the figures resulting from the concentration of each substance in the product that is classified with R52 with the concentration limit for the classification as defined in the product, Environmental Dangerous with R52 is greater than or equal to 1, i.e. :
AL2280_15_17.png Size : (74 X 36)
where
P R52 the concentration of each substance in the product that is classified as environmentally hazardous to R52 and
L R52 the concentration limits for the classification of the product as environmentally hazardous to R52 for each substance in the product classified as environmentally hazardous to R52 is classified.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to R52 is the following value :
L R52 : 25%
4.3.3.
Unwanted long-term effects in the aquatic environment
In calculating the classification of products because of their long-term adverse effects in the aquatic environment, the content substances which meet the criteria for classification due to such effects are taken into consideration.
4.3.3.1.
If there is only such a substance, the classification of the following table shall be shown in the product.
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances is set out other concentration limits.
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
Classification of the substance
R53
Concentration (weight percent) of the substance in the product
0% ≤ konc. < 25%
25% ≤ konc.
R53
4.3.3.2.
If, in the product, more than one substance which is classified according to section 4.2.1, the classification of the product shall be calculated according to the following criteria : the product is assigned the hazard symbol, the indication of danger and the phrase (s) of the phrase (s) corresponding to the classification of the product.
4.3.3.3.
The product shall be classified as environmentally hazardous to R53 if the sum of the figures resulting from the concentration of each substance in the product that is classified with R53 with the concentration limit for the classification as defined for this substance, environmental hazard with R53 is greater than or equal to 1, i.e. :
AL2280_15_18.png Size : (69 X 36)
where
P R53 the concentration of each substance in the product that is classified as environmentally hazardous to R53 and
L R53 the concentration limit for the classification of the product as environmentally hazardous to R53 for each substance in the product, classified as environmentally hazardous to R53.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to R53 is used as the following value :
L R53 : 25%
4.3.3.4.
The product shall be classified as environmentally hazardous to R53 if the sum of the figures resulting from the concentration of each substance in the product, classified as R53, N, R50/53, N, R51/53 or R52/53 with the applicable for this substance for this substance, the classification limit for classification as R52/53 is greater than or equal to 1, in other words :
AL2280_15_19.png Size : (289 X 37)
where
P R53 , P N, R50/53 , P N, R51/53 and P R52/53 is the concentration of each substance in the product that is classified as respectively R53, N, R50/53, N, R51/53 and R52/53 and
L R53-R53 YOU'RE NOT N, R50/53-R53 YOU'RE NOT N, R51/53-R53 and L R52/53-R53 the concentration limits for the classification of the product as environmentally hazardous to R53 for each substance in the product, classified as environmentally hazardous to R53, N, R50/53, N, R51/53 and R52/53 shall be classified as &quot; dangerous &quot; for each substance.
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as dangerous to the environment is dangerous with R53 is the following value :
L R53-R53 : 25%
L N, R50/53-R53 : 25%
L N, R51/53-R53 : 25%
L R52/53-R53 : 25%
4.3.4.
Other ecosystems other than the aquatic environment
The terrestrial environment
Classification of products using the following risk phrases shall be carried out when detailed criteria for the use of these sentences have been drawn up.
R54 Toxic to plants
R55 Toxic to animals
R56 Toxic to grounders in soil
R57 Toxic to bees
R58 May cause undesirable long-term effects in the environment
4.3.5.
The ozone layer
For the purposes of calculating the classification of products on account of their dangerous effect on the ozone layer, the content substances that meet the classification criteria as a result of such effects shall be taken into account in the ozone layer, cf. item 4.2.2.1.
4.3.5.1.
If at least one such substance is included in the product, the classification of the following table shall be classified.
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances is set out other concentration limits.
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
Classification of the substance
N with R59
Concentration (weight percent) of the substance in the product
0.0.1%
N, R59
5.
VALG OF SIKKERHEDSSARY (S-phrases)
Safety phrases (S-phrases) must be allocated to substances and products in accordance with the following general criteria. In the case of certain products, the safety requirements set out in Annex 2 are also mandatory.
In all parts of paragraph 5 where the word manufacturer is mentioned, the manufacturer or importer who is responsible for the placing on the market of the substance or the product is believed to be the manufacturer or the product.
S1
Store under lock
used for
-WHAT?
very toxic, toxic and corrosive substances and products ;
use criteria :
-WHAT?
obligatory for very toxic, toxic and corrosive substances and products if they are sold for private use.
S2
Keep out of reach of children
used for
-WHAT?
all dangerous substances and products,
use criteria :
-WHAT?
obligatory for all dangerous substances and products where they are sold for private use, except those products and products which are only environmentally hazardous.
S3
Store Queue
used for
-WHAT?
organic peroxides
-WHAT?
other dangerous substances and products with a boiling point ≤ 40 ° C,
use criteria,
-WHAT?
obligatory for organic peroxides unless S47 is used ;
-WHAT?
recommended for other dangerous substances and products with a code of &lt; 40 ° C,
S4
Do not be stored in proximity to inhabitation
used for
-WHAT?
very toxic and toxic substances and products,
use criteria :
-WHAT?
normally limited to very toxic and toxic substances and products if S13 should be supplemented, for example, when inhaling, and the substance or product should not be stored in the vicination of inhabitation. The S statement does not preclube the use of the substance or of the product in the vicinal of inhabitation when applied in the right way.
S5
Stay under there. (a suitable liquid indicated by the manufacturer)
used for
-WHAT?
spontaneous fixed substances and products,
use criteria :
-WHAT?
normally limited to special cases, such as sodium, potassium and white phosphorus.
S6
Stay under there. (inactive gas, as indicated by the manufacturer)
used for
-WHAT?
dangerous substances and products to be kept under an inert atmosphere ;