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 EuropeanChemicals Agency, amending Directive 1999/45/EC andrepealing Council Regulation (EEC) No 793/93 and CommissionRegulation (EC) No 1488/94 as well as Council Directive76/769/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 importersof substances on their own, in preparations or articles,as well as provisions concerning evaluation of substancesand the obligations of downstream users. Article 2(7)(a)of that Regulation provides that substances included inAnnex IV are exempted from Titles II, V and VI of thesame regulation as sufficient information is known aboutthese substances that they are considered to causeminimum risk because of their intrinsic properties. Inaddition, Article 2(7)(b) of the same Regulation
provides that substances covered by Annex V are
exempted from the same titles of the Regulation, asregistration is deemed inappropriate or unnecessary forthese substances and their exemption from these titlesdoes not prejudice the objectives of the Regulation.
(2) Article 138(4) of that Regulation requires theCommission to review Annexes IV and V by 1 June2008 with a view to proposing amendments, ifappropriate.
(3) The review carried out by the Commission pursuant toArticle 138(4) has revealed that three substances listed inAnnex IV should be removed from that Annex, as insuf­ficient information is known about these substances forthem to be considered as causing minimum risk becauseof their intrinsic properties. This is the case with vitaminA, as that substance may present significant risks ofreproductive 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 thisAnnex.
(4) Furthermore, three noble gases (helium, neon and xenon)fulfil the criteria for inclusion into Annex IV and shouldtherefore be moved there from Annex V. Another noblegas, krypton, which meets the criteria for inclusion inAnnex IV, should be added to the Annex for reasonsof consistency. Three other substances (fructose,galactose and lactose) should be added because theyhave been identified as meeting the criteria forinclusion in Annex IV. Limestone should be deletedfrom Annex IV as it is a mineral and is alreadyexempted in Annex V. Finally, certain existing entrieson oils, fats, waxes, fatty acids and their salts shouldbe deleted, as not all of those substances meet thecriteria 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 tosubstances with a lower hazard profile.
(5) The review carried out by the Commission pursuant toArticle 138(4) of the Regulation has revealed that certainamendments should also be made to Annex V. Magnesiashould be added, as it has been identified as a substancemeeting the criteria for inclusion in Annex V. What ismore, it is appropriate to add certain types of glass andceramic frits which do not meet the classification criteriaset out in Council Directive 67/548/EEC (
2) and which, in
addition, do not have dangerous constituents above therelevant concentration limits, unless there is scientificdata 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 obtainedfrom natural sources, which are not chemicallymodified 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 substancesand to limit the exemption to substances with lowerhazard properties. The same applies to certain fattyacids, which are obtained from natural sources andwhich are not chemically modified and which do nothave any hazardous properties beyond flammability andskin or eye irritancy. The addition of oils, fats, waxes andfatty acids in Annex V corresponds to the deletion ofcertain individual substances of these groups listed inAnnex IV.EN L 268/14 Official Journal of the European Union 9.10.2008
(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.(6) The amendments provided for in this Regulation, in
particular compost and biogas, are without prejudice toCommunity legislation on waste.
(7) The measures provided for in this Regulation are inaccordance 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 CommissionEN 9.10.2008 Official Journal of the European Union L 268/15ANNEX 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 C 6H8O6 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 C 6H14O6 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 C 9H17NO 5.1/2Ca 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 7440-01-9231-147-0 Argon Ar 7440-37-1231-168-5 Helium He 7440-59-7231-172-7 Xenon Xe 7440-63-3
231-783-9 Nitrogen N
2 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 acid8002-43-5
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 malto­
dextrins8029-43-4EN L 268/16 Official Journal of the European Union 9.10.2008Einecs No Name/Group CAS No
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 thepresence of water9005-25-8
232-940-4 Maltodextrin 9050-36-6
238-976-7 Sodium D-gluconate C
6H12O7.xNa 14906-97-9
248-027-9 D-glucitol monostearate C24H48O7 26836-47-5
262-988-1 Fatty acids, coco, Me esters 61788-59-8265-995-8 Cellulose pulp 65996-61-4
266-948-4 Glycerides, C
16-18 and C 18-unsaturated.
This substance is identified by SDA Substance Name: C16-C18and C18unsa­
turated trialkyl glyceride and SDA Reporting Number: 11-001-0067701-30-8
268-616-4 Syrups, corn, dehydrated 68131-37-3
269-658-6 Glycerides, tallow mono-, di- and tri-, hydrogenated 68308-54-3270-312-1 Glycerides, C
16-18 and C18-unsaturated, mono- and di-
This substance is identified by SDA Substance Name: C16-C18and C18unsa­
turated alkyl and C16-C18and C18unsaturated dialkyl glyceride and SDA
Reporting Number: 11-002-0068424-61-3
288-123-8 Glycerides, C10-18 85665-33-4 ’EN 9.10.2008 Official Journal of the European Union L 268/17ANNEX 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 arepersistent, 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 unlessthey 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 C
6to C24and
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.EN L 268/18 Official Journal of the European Union 9.10.200811. 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 outin Directive 1999/45/EC or concentration limits set out in Annex I to Directive 67/548/EEC, unless conclusivescientific 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. ’EN 9.10.2008 Official Journal of the European Union L 268/19