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)
Date: 2008-10-08
Institutions: European Commission
Subjects: administrative formalities, chemical product, dangerous substance, environmental risk prevention, marketing standard, scientific report

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EN

Official Journal of the European Union

9.10.2008

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
Community,

establishing the European

in particular due to the fact

reproductive toxicity. This is also the case with carbon
and graphite,
the
concerned Einecs and/or CAS numbers are used to
identify forms of carbon or graphite at the nano-scale,
the criteria for inclusion in this
which do not meet
Annex.

that

(4)

(5)

regard

Having
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
91/155/EEC,
93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular
Article 131 thereof,

Commission

Directives

and

Whereas:

(1)

(2)

(3)

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
they are considered to cause
these substances
minimum risk because of their intrinsic properties.
In
same Regulation
addition, Article 2(7)(b) of
substances covered by Annex V are
provides
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.

that

that

the

of

138(4)

that Regulation

Article
the
Commission to review Annexes IV and V by 1 June
2008 with a view to proposing amendments,
if
appropriate.

requires

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 insuf­
ficient 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

other

Three

substances

consistency.

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
(fructose,
of
galactose and lactose) should be added because they
have been identified as meeting
for
inclusion in Annex IV. Limestone should be deleted
from Annex IV as
is a mineral and is already
exempted in Annex V. Finally, certain existing entries
on oils, fats, waxes, fatty acids and their salts should
the
be deleted, as not all of
criteria for
is more
consistent to include them in a generic entry in Annex
the exemption to
V, using a formulation to limit
substances with a lower hazard profile.

inclusion in Annex IV and it

those substances meet

criteria

the

it

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
chemically
modified and which do not have any hazardous prop­
erties 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.

sources, which are not

(1) OJ L 396, 30.12.2006, p. 1; as

corrected by OJ L 136,

29.5.2007, p. 3.

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

9.10.2008

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Official Journal of the European Union

L 268/15

(6)

(7)

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

Article 2

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

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

under Article

Regulation

of

Article 3

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

HAS ADOPTED THIS REGULATION:

Done at Brussels, 8 October 2008.

Article 1

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

For the Commission

Stavros DIMAS
Member of the Commission

L 268/16

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Official Journal of the European Union

9.10.2008

ANNEX I

‘ANNEX IV

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

Einecs No

Name/Group

200-061-5

D-glucitol C6H14O6

200-066-2

Ascorbic acid C6H8O6

200-075-1

Glucose C6H12O6

200-233-3

Fructose C6H12O6

200-294-2

L-lysine C6H14N2O2

200-334-9

Sucrose, pure C12H22O11

200-405-4

α-tocopheryl acetate C31H52O3

200-416-4

Galactose C6H12O6

200-432-1

DL-methionine C5H11NO2S

200-559-2

Lactose C12H22O11

200-711-8

D-mannitol C6H14O6

201-771-8

L-sorbose C6H12O6

204-664-4

Glycerol stearate, pure C21H42O4

204-696-9

Carbon dioxide CO2

205-278-9

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

205-756-7

DL-phenylalanine C9H11NO2

208-407-7

Sodium gluconate C6H12O7.Na

215-665-4

Sorbitan oleate C24H44O6

231-098-5

Krypton Kr

231-110-9

Neon Ne

231-147-0

Argon Ar

231-168-5

Helium He

231-172-7

Xenon Xe

231-783-9

Nitrogen N2

231-791-2

Water, distilled, conductivity or of similar purity H2O

232-307-2

232-436-4

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

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 malto­
dextrins

CAS No

50-70-4

50-81-7

50-99-7

57-48-7

56-87-1

57-50-1

58-95-7

59-23-4

59-51-8

63-42-3

69-65-8

87-79-6

123-94-4

124-38-9

137-08-6

150-30-1

527-07-1

1338-43-8

7439-90-9

7440-01-9

7440-37-1

7440-59-7

7440-63-3

7727-37-9

7732-18-5

8002-43-5

8029-43-4

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Einecs No

Name/Group

232-442-7

Tallow, hydrogenated

232-675-4

Dextrin

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

232-940-4

Maltodextrin

238-976-7

Sodium D-gluconate C6H12O7.xNa

248-027-9

D-glucitol monostearate C24H48O7

262-988-1

Fatty acids, coco, Me esters

265-995-8

Cellulose pulp

266-948-4

Glycerides, C16-18 and C18-unsaturated.
This substance is identified by SDA Substance Name: C16-C18 and C18 unsa­
turated trialkyl glyceride and SDA Reporting Number: 11-001-00

268-616-4

Syrups, corn, dehydrated

269-658-6

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

270-312-1

Glycerides, C16-18 and C18-unsaturated, mono- and di-
This substance is identified by SDA Substance Name: C16-C18 and C18 unsa­
turated alkyl and C16-C18 and C18 unsaturated dialkyl glyceride and SDA
Reporting Number: 11-002-00

288-123-8

Glycerides, C10-18

CAS No

8030-12-4

9004-53-9

9005-25-8

9050-36-6

14906-97-9

26836-47-5

61788-59-8

65996-61-4

67701-30-8

68131-37-3

68308-54-3

68424-61-3

85665-33-4’

L 268/18

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Official Journal of the European Union

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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.

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

or article.

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.

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

(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.

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.

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.

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).

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.

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.

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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.

12. Compost and biogas.

13. Hydrogen and oxygen.’