EN    EN EN  
EN    EN  COMMISSION OF THE E UROPEAN 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 re gards Annexes IV and V   
EN 2   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 re gards Annexes IV and V  
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing 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 (REA CH), 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 re gistration 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 Re gulation 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 prope rties. 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 registrati on 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 Regul ation requires the Commission to review Annexes IV and 
V by 1 June 2008 with a view to prop osing 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 3   EN (3) The review carried out by th e Commission pursuant to Articl e 138(4) has revealed that 
three substances listed in A nnex 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 propert ies. This is the case with vitamin A, as 
that substance may present significant risks of reproductive toxicit y. 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 crite ria for inclusion in this annex. 
(4) Furthermore, three noble ga ses (helium, neon and xenon ) fulfil the criteria for 
inclusion into Annex IV and should therefor e 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 consis tency. Three other subs tances (fructose, 
galactose and lactose) should be added because they have been identified as meeting the criteria for inclusion in Annex IV. Lime stone 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 sa lts 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 Commissi on pursuant to Article 138(4) of the 
Regulation has revealed that certain amendments should al so be made to Annex V. 
Magnesia should be added, as it has been iden tified as a substance meeting the criteria 
for inclusion in Annex V. What is more, it is  appropriate to add cer tain types of glass 
and ceramic frits which do not meet the clas sification 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 vege table oils, fats and wa xes 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 fa tty 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 Regulat ion, in particular compost and biogas, are 
without prejudice to Commun ity legislation on waste. 
(7) The measures provided for in this Regulati on 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 4   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 5   EN ANNEX I  
"ANNEX IV 
EXEMPTIONS FROM THE OB LIGATION TO REGISTER  
IN ACCORDANCE WITH ARTICLE 2(7)(a) 
EINECS No Name/Group CAS No 
200-061-5 D-glucitol C 6H14O6 50-70-4 
200-066-2 Ascorbic acid C 6H8O6 50-81-7 
200-075-1 Glucose C 6H12O6 50-99-7 
200-233-3 Fructose C 6H12O6 57-48-7 
200-294-2 L-lysine C 6H14N2O2 56-87-1 
200-334-9 Sucrose, pure C 12H22O11 57-50-1 
200-405-4 α-tocopheryl acetate C 31H52O3 58-95-7 
200-416-4 Galactose C 6H12O6 59-23-4 
200-432-1 DL-methionine C 5H11NO 2S 59-51-8 
200-559-2 Lactose C 12H22O11 63-42-3 
200-711-8 D-mannitol C 6H14O6 69-65-8 
201-771-8 L-sorbose C 6H12O6 87-79-6  
EN 6   EN EINECS No Name/Group CAS No 
204-664-4 Glycerol stearate, pure C 21H42O4 123-94-4 
204-696-9 Carbon dioxide CO 2 124-38-9 
205-278-9 Calcium pantothenate, D-form 
C9H17NO 5.1/2Ca 137-08-6 
205-756-7 DL-phenylalanine C 9H11NO 2 150-30-1 
208-407-7 Sodium gluconate C 6H12O7.Na 527-07-1 
215-665-4 Sorbitan oleate C 24H44O6 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 N 2 7727-37-9 
231-791-2 Water, distilled, conductivity or of similar 
purity H 2O 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  
EN 7   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 
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 C 6H12O7.xNa 14906-97-9 
248-027-9 D-glucitol monostearate C 24H48O7 26836-47-5 
262-988-1 Fatty acids, coco, Me esters 61788-59-8 
265-995-8 Cellulose Pulp 65996-61-4  
EN 8   EN EINECS No Name/Group CAS No 
266-948-4 Glycerides, C 16-18 and C 18-unsaturated. 
This substance is identified by SDA 
Substance Name: C 16-C18 and C 18 
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, C 16-18 and C 18-unsaturated. 
mono- and di- 
This substance is identified by SDA 
Substance Name: C 16-C18 and C 18 
unsaturated alkyl and C 16-C18 and C 18 
unsaturated dialkyl glyceride and SDA Reporting Number: 11-002-00. 68424-61-3 
288-123-8 Glycerides, C 10-18 85665-33-4" 
  
EN 9   EN ANNEX II 
"ANNEX V 
EXEMPTIONS FROM THE OB LIGATION TO REGISTER 
IN ACCORDANCE WITH ARTICLE 2(7)(b) 
1. Substances which result from a chemical reac tion that occurs incidental to exposure of 
another substance or article to environmenta l factors such as air, moisture, microbial 
organisms or sunlight. 
2. Substances which result from a chemical reac tion that occurs incidental to storage of 
another substance, preparation or article. 
3. Substances which result from a chemi cal 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 manuf actured, imported or placed on the market 
and which result from a chemical reaction that occurs when: 
 (a) a stabiliser, colorant, flavouring agen t, antioxidant, filler,  solvent, carrier, 
surfactant, plasticiser, corrosion inhibitor, anti foamer or defoamer, dispersant, precipitation 
inhibitor, desiccant, binder, emulsifier, de-emuls ifier, dewatering agent, agglomerating agent, 
adhesion promoter, flow modifier , pH neutraliser, sequesterant , coagulant, flocculant, fire 
retardant, lubricant, chelating agent, or qual ity control reagent func tions 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 re gistered by the manufacturer or importer using 
this exemption. 
7. The following substances which occur in natu re, if they are not chemically modified: 
Minerals, ores, ore concentrates, raw and processed natural gas, crude oil, coal.  
EN 10   EN 8. Substances which occur in nature other than  those listed under paragraph 7, if they are 
not chemically modified, unless they meet th e 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 accord ance 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 natu ral sources, if they are not chemically 
modified, unless they meet the criteria for cl assification as dangerous according to Directive 
67/548/EEC with the exception of those only classifi ed as flammable [R10], as a skin irritant 
[R38] or as an eye irritant [R 36] or unless they ar e persistent, bioaccumulative and toxic or 
very persistent and very bioaccumulative in accord ance 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, ve getable waxes; animal fats, anim al oils, animal waxes; fatty 
acids from C 6 to C 24 and their potassium, sodium, calci um 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 th e 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 acco rdance with Directive 67/548/EEC present in 
concentrations above the lowest  of the applicable concentra tion limits set out in Directive 
1999/45/EC or concentration lim its set out in Annex I to Directive 67/548/EEC, unless 
conclusive scientific experime ntal data show that these c onstituents 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. "