Information about http://www.buyusa.gov/europeanunion/draft_annexes_iv_and_v.pdf
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Created: Thu Jul 24 09:19:12 2008
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EN
EN EN
COMMISSION OF THE EUROPEAN COMMUNITIES
Brussels, XX.Y.2008
D000689/02
Draft
COMMISSION REGULATION (EC) No .../..
of
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
EN EN
Draft
COMMISSION REGULATION (EC) No .../..
of
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/EC1, 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.
(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.
1
OJ L 396, 30.12.2006, p. 1. Regulation as amended by Regulation (EC) No 1354/2007 (OJ L 304,
22.11.2007, p. 1).
EN 2 EN
(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.
(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 Directive
67/548/EEC 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.
(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.
EN 3 EN
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 that of its publication in the
Official Journal of the European Union.
Done at Brussels,
For the Commission
Stavros DIMAS Günter Verheugen
Member of the Commission Member of the Commission
EN 4 EN
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 -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
EN 5 EN
EINECS No Name/Group CAS No
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 137-08-6
C9H17NO5.1/2Ca
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 7732-18-5
purity H2O
232-307-2 Lecithins 8002-43-5
The complex combination of diglycerides
of fatty acids linked to the choline ester of
phosphoric acid.
232-436-4 Syrups, hydrolyzed starch 8029-43-4
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.
EN 6 EN
EINECS No Name/Group CAS No
232-442-7 Tallow, hydrogenated 8030-12-4
232-675-4 Dextrin 9004-53-9
232-679-6 Starch 9005-25-8
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 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
EN 7 EN
EINECS No Name/Group CAS No
266-948-4 Glycerides, C16-18 and C18-unsaturated. 67701-30-8
This substance is identified by SDA
Substance Name: C16-C18 and C18
unsaturated trialkyl glyceride and SDA
Reporting Number: 11-001-00.
268-616-4 Syrups, corn, dehydrated 68131-37-3
269-658-6 Glycerides, tallow mono-, di- and tri-, 68308-54-3
hydrogenated
270-312-1 Glycerides, C16-18 and C18-unsaturated. 68424-61-3
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.
288-123-8 Glycerides, C10-18 85665-33-4"
EN 8 EN
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.
EN 9 EN
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.
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 life-cycle 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 10 EN