# L_2008268EN.01001401.xml

| 9.10.2008 | EN | Official Journal of the European Union | L 268/14 |
| --- | --- | --- | --- |

9.10.2008

EN

Official Journal of the European Union

L 268/14

---

COMMISSION REGULATION (EC) No 987/2008

of 8 October 2008

amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1907/2006 of 18 December 2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Article 131 thereof,

Whereas:

| (1) | Regulation (EC) No 1907/2006 establishes registration obligations of Community manufacturers or importers of substances on their own, in preparations or articles, as well as provisions concerning evaluation of substances and the obligations of downstream users. Article 2(7)(a) of that Regulation provides that substances included in Annex IV are exempted from Titles II, V and VI of the same regulation as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties. In addition, Article 2(7)(b) of the same Regulation provides that substances covered by Annex V are exempted from the same titles of the Regulation, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these titles does not prejudice the objectives of the Regulation. |
| --- | --- |

(1)

Regulation (EC) No 1907/2006 establishes registration obligations of Community manufacturers or importers of substances on their own, in preparations or articles, as well as provisions concerning evaluation of substances and the obligations of downstream users. Article 2(7)(a) of that Regulation provides that substances included in Annex IV are exempted from Titles II, V and VI of the same regulation as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties. In addition, Article 2(7)(b) of the same Regulation provides that substances covered by Annex V are exempted from the same titles of the Regulation, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these titles does not prejudice the objectives of the Regulation.

| (2) | Article 138(4) of that Regulation requires the Commission to review Annexes IV and V by 1 June 2008 with a view to proposing amendments, if appropriate. |
| --- | --- |

(2)

Article 138(4) of that Regulation requires the Commission to review Annexes IV and V by 1 June 2008 with a view to proposing amendments, if appropriate.

| (3) | The review carried out by the Commission pursuant to Article 138(4) has revealed that three substances listed in Annex IV should be removed from that Annex, as insufficient information is known about these substances for them to be considered as causing minimum risk because of their intrinsic properties. This is the case with vitamin A, as that substance may present significant risks of reproductive toxicity. This is also the case with carbon and graphite, in particular due to the fact that the concerned Einecs and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in this Annex. |
| --- | --- |

(3)

The review carried out by the Commission pursuant to Article 138(4) has revealed that three substances listed in Annex IV should be removed from that Annex, as insufficient information is known about these substances for them to be considered as causing minimum risk because of their intrinsic properties. This is the case with vitamin A, as that substance may present significant risks of reproductive toxicity. This is also the case with carbon and graphite, in particular due to the fact that the concerned Einecs and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in this Annex.

| (4) | Furthermore, three noble gases (helium, neon and xenon) fulfil the criteria for inclusion into Annex IV and should therefore be moved there from Annex V. Another noble gas, krypton, which meets the criteria for inclusion in Annex IV, should be added to the Annex for reasons of consistency. Three other substances (fructose, galactose and lactose) should be added because they have been identified as meeting the criteria for inclusion in Annex IV. Limestone should be deleted from Annex IV as it is a mineral and is already exempted in Annex V. Finally, certain existing entries on oils, fats, waxes, fatty acids and their salts should be deleted, as not all of those substances meet the criteria for inclusion in Annex IV and it is more consistent to include them in a generic entry in Annex V, using a formulation to limit the exemption to substances with a lower hazard profile. |
| --- | --- |

(4)

Furthermore, three noble gases (helium, neon and xenon) fulfil the criteria for inclusion into Annex IV and should therefore be moved there from Annex V. Another noble gas, krypton, which meets the criteria for inclusion in Annex IV, should be added to the Annex for reasons of consistency. Three other substances (fructose, galactose and lactose) should be added because they have been identified as meeting the criteria for inclusion in Annex IV. Limestone should be deleted from Annex IV as it is a mineral and is already exempted in Annex V. Finally, certain existing entries on oils, fats, waxes, fatty acids and their salts should be deleted, as not all of those substances meet the criteria for inclusion in Annex IV and it is more consistent to include them in a generic entry in Annex V, using a formulation to limit the exemption to substances with a lower hazard profile.

| (5) | The review carried out by the Commission pursuant to Article 138(4) of the Regulation has revealed that certain amendments should also be made to Annex V. Magnesia should be added, as it has been identified as a substance meeting the criteria for inclusion in Annex V. What is more, it is appropriate to add certain types of glass and ceramic frits which do not meet the classification criteria set out in Council Directive 67/548/EEC (2) and which, in addition, do not have dangerous constituents above the relevant concentration limits, unless there is scientific data proving that these constituents are not available. Certain vegetable oils, fats and waxes and animal oils, fats and waxes, as well as glycerol, that are obtained from natural sources, which are not chemically modified and which do not have any hazardous properties beyond flammability and skin or eye irritancy, should be added to Annex V in order to provide a more consistent treatment of comparable substances and to limit the exemption to substances with lower hazard properties. The same applies to certain fatty acids, which are obtained from natural sources and which are not chemically modified and which do not have any hazardous properties beyond flammability and skin or eye irritancy. The addition of oils, fats, waxes and fatty acids in Annex V corresponds to the deletion of certain individual substances of these groups listed in Annex IV. |
| --- | --- |

(5)

The review carried out by the Commission pursuant to Article 138(4) of the Regulation has revealed that certain amendments should also be made to Annex V. Magnesia should be added, as it has been identified as a substance meeting the criteria for inclusion in Annex V. What is more, it is appropriate to add certain types of glass and ceramic frits which do not meet the classification criteria set out in Council Directive 67/548/EEC (2) and which, in addition, do not have dangerous constituents above the relevant concentration limits, unless there is scientific data proving that these constituents are not available. Certain vegetable oils, fats and waxes and animal oils, fats and waxes, as well as glycerol, that are obtained from natural sources, which are not chemically modified and which do not have any hazardous properties beyond flammability and skin or eye irritancy, should be added to Annex V in order to provide a more consistent treatment of comparable substances and to limit the exemption to substances with lower hazard properties. The same applies to certain fatty acids, which are obtained from natural sources and which are not chemically modified and which do not have any hazardous properties beyond flammability and skin or eye irritancy. The addition of oils, fats, waxes and fatty acids in Annex V corresponds to the deletion of certain individual substances of these groups listed in Annex IV.

| (6) | The amendments provided for in this Regulation, in particular compost and biogas, are without prejudice to Community legislation on waste. |
| --- | --- |

(6)

The amendments provided for in this Regulation, in particular compost and biogas, are without prejudice to Community legislation on waste.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

HAS ADOPTED THIS REGULATION:

Article 1

Annex IV to Regulation (EC) No 1907/2006 is replaced by Annex I to this Regulation.

Article 2

Annex V to Regulation (EC) No 1907/2006 is replaced by Annex II to this Regulation.

Article 3

This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.

Done at Brussels, 8 October 2008.

For the Commission

Stavros DIMAS

Member of the Commission

---

(1)  
  OJ L 396, 30.12.2006, p. 1; as corrected by OJ L 136, 29.5.2007, p. 3.

1

(2)  
  OJ 196, 16.8.1967, p. 1.

2

---

ANNEX I

‘ANNEX IV

EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a)

| Einecs No | Name/Group | CAS No |
| --- | --- | --- |
| 200-061-5 | D-glucitol C6H14O6 | 50-70-4 |
| 200-066-2 | Ascorbic acid C6H8O6 | 50-81-7 |
| 200-075-1 | Glucose C6H12O6 | 50-99-7 |
| 200-233-3 | Fructose C6H12O6 | 57-48-7 |
| 200-294-2 | L-lysine C6H14N2O2 | 56-87-1 |
| 200-334-9 | Sucrose, pure C12H22O11 | 57-50-1 |
| 200-405-4 | α-tocopheryl acetate C31H52O3 | 58-95-7 |
| 200-416-4 | Galactose C6H12O6 | 59-23-4 |
| 200-432-1 | DL-methionine C5H11NO2S | 59-51-8 |
| 200-559-2 | Lactose C12H22O11 | 63-42-3 |
| 200-711-8 | D-mannitol C6H14O6 | 69-65-8 |
| 201-771-8 | L-sorbose C6H12O6 | 87-79-6 |
| 204-664-4 | Glycerol stearate, pure C21H42O4 | 123-94-4 |
| 204-696-9 | Carbon dioxide CO2 | 124-38-9 |
| 205-278-9 | Calcium pantothenate, D-form C9H17NO5.1/2Ca | 137-08-6 |
| 205-756-7 | DL-phenylalanine C9H11NO2 | 150-30-1 |
| 208-407-7 | Sodium gluconate C6H12O7.Na | 527-07-1 |
| 215-665-4 | Sorbitan oleate C24H44O6 | 1338-43-8 |
| 231-098-5 | Krypton Kr | 7439-90-9 |
| 231-110-9 | Neon Ne | 7440-01-9 |
| 231-147-0 | Argon Ar | 7440-37-1 |
| 231-168-5 | Helium He | 7440-59-7 |
| 231-172-7 | Xenon Xe | 7440-63-3 |
| 231-783-9 | Nitrogen N2 | 7727-37-9 |
| 231-791-2 | Water, distilled, conductivity or of similar purity H2O | 7732-18-5 |
| 232-307-2 | Lecithins
  The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid | 8002-43-5 |
| 232-436-4 | Syrups, hydrolyzed starch
  A complex combination obtained by the hydrolysis of cornstarch by the action of acids or enzymes. It consists primarily of d-glucose, maltose and maltodextrins | 8029-43-4 |
| 232-442-7 | Tallow, hydrogenated | 8030-12-4 |
| 232-675-4 | Dextrin | 9004-53-9 |
| 232-679-6 | Starch
  High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinised by heating in the presence of water | 9005-25-8 |
| 232-940-4 | Maltodextrin | 9050-36-6 |
| 238-976-7 | Sodium D-gluconate C6H12O7.xNa | 14906-97-9 |
| 248-027-9 | D-glucitol monostearate C24H48O7 | 26836-47-5 |
| 262-988-1 | Fatty acids, coco, Me esters | 61788-59-8 |
| 265-995-8 | Cellulose pulp | 65996-61-4 |
| 266-948-4 | Glycerides, C16-18 and C18-unsaturated.
  This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated trialkyl glyceride and SDA Reporting Number: 11-001-00 | 67701-30-8 |
| 268-616-4 | Syrups, corn, dehydrated | 68131-37-3 |
| 269-658-6 | Glycerides, tallow mono-, di- and tri-, hydrogenated | 68308-54-3 |
| 270-312-1 | Glycerides, C16-18 and C18-unsaturated, mono- and di-
  This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl and C16-C18 and C18 unsaturated dialkyl glyceride and SDA Reporting Number: 11-002-00 | 68424-61-3 |
| 288-123-8 | Glycerides, C10-18 | 85665-33-4’ |

Einecs No

Name/Group

CAS No

200-061-5

D-glucitol C6H14O6

50-70-4

200-066-2

Ascorbic acid C6H8O6

50-81-7

200-075-1

Glucose C6H12O6

50-99-7

200-233-3

Fructose C6H12O6

57-48-7

200-294-2

L-lysine C6H14N2O2

56-87-1

200-334-9

Sucrose, pure C12H22O11

57-50-1

200-405-4

α-tocopheryl acetate C31H52O3

58-95-7

200-416-4

Galactose C6H12O6

59-23-4

200-432-1

DL-methionine C5H11NO2S

59-51-8

200-559-2

Lactose C12H22O11

63-42-3

200-711-8

D-mannitol C6H14O6

69-65-8

201-771-8

L-sorbose C6H12O6

87-79-6

204-664-4

Glycerol stearate, pure C21H42O4

123-94-4

204-696-9

Carbon dioxide CO2

124-38-9

205-278-9

Calcium pantothenate, D-form C9H17NO5.1/2Ca

137-08-6

205-756-7

DL-phenylalanine C9H11NO2

150-30-1

208-407-7

Sodium gluconate C6H12O7.Na

527-07-1

215-665-4

Sorbitan oleate C24H44O6

1338-43-8

231-098-5

Krypton Kr

7439-90-9

231-110-9

Neon Ne

7440-01-9

231-147-0

Argon Ar

7440-37-1

231-168-5

Helium He

7440-59-7

231-172-7

Xenon Xe

7440-63-3

231-783-9

Nitrogen N2

7727-37-9

231-791-2

Water, distilled, conductivity or of similar purity H2O

7732-18-5

232-307-2

Lecithins

The complex combination of diglycerides of fatty acids linked to the choline ester of phosphoric acid

8002-43-5

232-436-4

Syrups, hydrolyzed starch

A complex combination obtained by the hydrolysis of cornstarch by the action of acids or enzymes. It consists primarily of d-glucose, maltose and maltodextrins

8029-43-4

232-442-7

Tallow, hydrogenated

8030-12-4

232-675-4

Dextrin

9004-53-9

232-679-6

Starch

High-polymeric carbohydrate material usually derived from cereal grains such as corn, wheat and sorghum, and from roots and tubers such as potatoes and tapioca. Includes starch which has been pregelatinised by heating in the presence of water

9005-25-8

232-940-4

Maltodextrin

9050-36-6

238-976-7

Sodium D-gluconate C6H12O7.xNa

14906-97-9

248-027-9

D-glucitol monostearate C24H48O7

26836-47-5

262-988-1

Fatty acids, coco, Me esters

61788-59-8

265-995-8

Cellulose pulp

65996-61-4

266-948-4

Glycerides, C16-18 and C18-unsaturated.

This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated trialkyl glyceride and SDA Reporting Number: 11-001-00

67701-30-8

268-616-4

Syrups, corn, dehydrated

68131-37-3

269-658-6

Glycerides, tallow mono-, di- and tri-, hydrogenated

68308-54-3

270-312-1

Glycerides, C16-18 and C18-unsaturated, mono- and di-

This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl and C16-C18 and C18 unsaturated dialkyl glyceride and SDA Reporting Number: 11-002-00

68424-61-3

288-123-8

Glycerides, C10-18

85665-33-4’

---

ANNEX II

‘ANNEX V

EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)

| 1. | Substances which result from a chemical reaction that occurs incidental to exposure of another substance or article to environmental factors such as air, moisture, microbial organisms or sunlight. |
| --- | --- |

1.

| 2. | Substances which result from a chemical reaction that occurs incidental to storage of another substance, preparation or article. |
| --- | --- |

2.

| 3. | Substances which result from a chemical reaction occurring upon end use of other substances, preparations or articles and which are not themselves manufactured, imported or placed on the market. |
| --- | --- |

3.

| 4. | Substances which are not themselves manufactured, imported or placed on the market and which result from a chemical reaction that occurs when:






  (a) | a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended; or |
| --- | --- | --- |

4.

(a)

a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, plasticiser, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifier, de-emulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended; or

| (b) | a substance solely intended to provide a specific physicochemical characteristic functions as intended. |
| --- | --- |

(b)

a substance solely intended to provide a specific physicochemical characteristic functions as intended.

| 5. | By-products, unless they are imported or placed on the market themselves. |
| --- | --- |

5.

| 6. | Hydrates of a substance or hydrated ions, formed by association of a substance with water, provided that the substance has been registered by the manufacturer or importer using this exemption. |
| --- | --- |

6.

| 7. | The following substances which occur in nature, if they are not chemically modified:
  Minerals, ores, ore concentrates, raw and processed natural gas, crude oil, coal. |
| --- | --- |

7.

Minerals, ores, ore concentrates, raw and processed natural gas, crude oil, coal.

| 8. | Substances which occur in nature other than those listed under paragraph 7, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f). |
| --- | --- |

8.

| 9. | The following substances obtained from natural sources, if they are not chemically modified, unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC with the exception of those only classified as flammable [R10], as a skin irritant [R38] or as an eye irritant [R36] or unless they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII or unless they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f):
  Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts; glycerol. |
| --- | --- |

9.

Vegetable fats, vegetable oils, vegetable waxes; animal fats, animal oils, animal waxes; fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts; glycerol.

| 10. | The following substances if they are not chemically modified:
  Liquefied petroleum gas, natural gas condensate, process gases and components thereof, coke, cement clinker, magnesia. |
| --- | --- |

10.

Liquefied petroleum gas, natural gas condensate, process gases and components thereof, coke, cement clinker, magnesia.

| 11. | The following substances unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC and provided that they do not contain constituents meeting the criteria as dangerous in accordance with Directive 67/548/EEC present in concentrations above the lowest of the applicable concentration limits set out in Directive 1999/45/EC or concentration limits set out in Annex I to Directive 67/548/EEC, unless conclusive scientific experimental data show that these constituents are not available throughout the lifecycle of the substance and those data have been ascertained to be adequate and reliable:
  Glass, ceramic frits. |
| --- | --- |

11.

Glass, ceramic frits.

| 12. | Compost and biogas. |
| --- | --- |

12.

| 13. | Hydrogen and oxygen.’ |
| --- | --- |

13.

---