EUROPEAN COMMISSION 

DIRECTORATE-GENERAL 

ENVIRONMENT 

Directorate D - Water, Chemicals & Cohesion 

ENV.D.1 – Chemicals 

EUROPEAN COMMISSION 

DIRECTORATE-GENERAL 

ENTERPRISE AND INDUSTRY 

Directorate G – Chemicals, Metals, Forest-based and Textile Industries 

ENTR.G.1 - REACH

CRITERIA FOR INCLUSION OF SUBSTANCES IN ANNEX IV OF 

REGULATION (EC) NO. 1907/2006

CONCERNING THE REGISTRATION, EVALUATION, AUTHORISATION AND RESTRICTION 

OF CHEMICALS (REACH) 
These criteria were endorsed by the REACH Competent Authorities on 19 October 2007. 

They constitute the first step in the review of Annex IV of the REACH Regulation to be 

carried out by the Commission (Article 138(4)). It should be noted that the final decision 

on the inclusion on to or deletion of substances from Annex IV will be taken through 

Comitology (regulatory procedure with scrutiny). 

The draft document was prepared by DHI, Protection Through Knowledge (PTK) Ltd., 

and Milieu on the basis of comments to the former draft version 2007.08.27 received 

from the Commission on 11, 14 and 21 September 2007, the meeting of the CA SubGroup(Annexes) on 1 October, 2007 and subsequent comments from CAs and industry 

(received from the Commission on 12 October 2007). 
1 INTRODUCTION 

One of the main purposes of Regulation (EC) No 1907/2006 of the European 

Parliament and the Council of 18 December 2006 (REACH) is to ensure a high 

level of protection of human health and the environment. REACH is based on 

the principle that manufacturers, importers and downstream users shall ensure 

that the manufacture, placing on the market and use of substances shall not 

adversely affect human health or the environment. As part of the registration 

procedure, the registrant is required to document that substances can be used in a 

safe manner, with regard to human health and the environment. 

Annex IV of REACH identifies substances that are exempted from the 

registration, evaluation and downstream user provisions of REACH on the basis 

that sufficient information is known about these substances so that they are 

considered to cause minimum risk because of their intrinsic properties (Article 

2(7)(a)). 

The current Annex IV of REACH essentially reproduces the list of substances 

excepted from the obligation to register under the present Existing Substances 

Regulation (Regulation (EEC) No 793/93). This list has not been revised since 

then, except with the addition of one substance, Cellulose Pulp, during the 

progress of the Regulation through the regulatory process. 

According to REACH (Article 138(4)), the Commission is to carry out a review 

of Annex IV by 1 June 2008, in order to consider whether additional substances 

should be added to the Annex and whether substances currently in the Annex 

meet the basic criterion that “sufficient information is known about these 

substances so that they are considered to cause minimum risk because of their 

intrinsic properties”. 

This review requires definition of the core requirements of “sufficient 

information” and “minimum risk” and the development of additional criteria for 

the evaluation of this information and the potential risk of substances to be 

included, or already included, in the Annex. Once the Commission, together 

with an advisory group of Member States and other stakeholders, have agreed on 

these criteria, the minimum data-set required and a format for adding or 

removing substances from Annex IV, the intent is to review each current entry 

and proposed new entry to see if it meets the criteria for inclusion in Annex IV, 

documenting the conclusion for the entry, and proposing addition to, or deletion 

from, the list as appropriate. 

This document provides a proposal for the assessment of whether substances 

should be included in Annex IV (section 2), the information and documentation 

requirements when making a submission requesting the addition of an additional 
substance to the current Annex IV (sections 3 and 4), and the subsequent review 

process (section 5). 

For the purposes of this review, 

 “Sufficient information” means: the information specified in section 3 

which is considered to be necessary to confirm the “minimum risk 

because of intrinsic properties” posed by a substance. 

 “Minimum risk because of intrinsic properties” means: that negligible 

risk can be assumed on the basis of the intrinsic properties of the 

substance. 

It is important to note that the principle of “minimum risk because of intrinsic 

properties” is clearly different from the approach applied in registration under 

REACH. The proposed criteria for minimum risk should apply at all tonnage 

levels and need to be independent of the specific uses of the substance and the 

resulting exposure of humans and the environment as all future uses cannot 

possibly be predicted. Consequently, the rules described in Annex XI section 3 

do not apply as they are based on an exposure assessment of a known use of the 

substance. Likewise, the tonnage of substances is not considered as the future 

level of manufacture and import of a substance cannot be predicted. The 

information requirements and associated criteria are therefore the same 

regardless of the tonnage currently manufactured in, or imported into, the EU. 

In developing the document, the following principles were followed: 

• A concrete description of what constitutes a “minimum risk because of 

intrinsic properties” needed to be developed. 

• Based on the description of “minimum risk because of intrinsic 

properties” information requirements were defined. 

2 CRITERIA FOR DETERMINING MINIMUM RISK 

BECAUSE OF INTRINSIC PROPERTIES 

As following Article 2.7(a) minimum risk in this exercise is based on intrinsic 

properties; use and exposure information will not be included. Using only 

information on intrinsic properties of the substance leads to a more uncertain 

determination of the magnitude of risk. Due to this inherent uncertainty and the 

need to include only substances which pose a minimum risk, strict hazard-based 

criteria needed to be developed. Such criteria are proposed below. Minimum risk 

because of intrinsic properties can only be concluded if all criteria for 

physicochemical properties, toxicological properties and ecotoxicological 

properties mentioned in sections 2.1 to 2.3 are met. 
2.1 Physicochemical properties 

All the following criteria must be met: 

1. The data specified in section 3 on Information requirements must be 

provided. 

2. The substance does not meet the criteria for classification as dangerous in 

accordance with Directive 67/548/EEC. 

3. The substance does not meet any of the criteria laid out in Appendix IA of 

this document for the following endpoints (a. to n.): 

a. Explosive, in Divisions 1.1, 1.2, 1.3, 1.4 and 1.5; 

b. Flammable gas, Category 1 or Category 2; 

c. Flammable liquid, Category 1, Category 2, Category 3 or Category 4; 

d. Flammable solid, Category 1 or Category 2; 

e. Oxidising gas, Category 1; 

f. Oxidising liquid, Category 1, Category 2 or Category 3; 

g. Oxidising solid, Category 1, Category 2 or Category 3; 

h. Corrosive to metals, Category 1; 

i. Self-reactive substance, Types A to F; 

j. Pyrophoric liquid, Category 1; 

k. Pyrophoric solid, Category 1; 

l. Self-heating substance, Category 1 or Category 2; 

m. Substance which in contact with water emits flammable gas, 

Category 1, Category 2 or category 3; 

n. Organic peroxide, of Type A to F. 
2.2 Toxicological properties 

All the following criteria must be met: 

1. The data specified in section 3 on Information Requirements must be 

provided. 

2. The substance does not meet the criteria for classification as dangerous in 

accordance with Directive 67/548/EEC. 

3. The substance does not meet the criteria for a substance of very high concern 

(SVHC) in accordance with Article 57 of REACH. 

4. The intrinsic properties of the substance are well below the criteria for 

classification as dangerous in accordance with Directive 67/548/EEC (using 

all available data for all relevant toxicological endpoints). This is 

demonstrated by an absence of ‘significant toxicological effects’ in the 

relevant toxicological studies. 

5. Absence of “significant toxicological effects” means: 

a. Acute oral toxicity: no evident toxicity1

 at dose levels ≤ 2000 mg/kg. 

Additionally the LD0 must be > 5000 mg/kg where the substance has 

been tested at this level; 

b. Acute dermal toxicity: no evident toxicity2 at dose levels ≤ 2000 

mg/kg. Additionally the LD0 must be > 5000 mg/kg where the 

substance has been tested at this level; 

c. Acute inhalational toxicity: no evident toxicity2 at an exposure level 

of ≤ 20 mg/litre/4h for gases or vapours and ≤ 5 mg/litre/4h for 

aerosols or particulates. Additionally the LD0 must be > 50 

mg/litre/4h for gases or vapours and > 12.5 mg/litre/4h for aerosols 

or particulates where the substance has been tested at this level; 

d. Skin irritation: the substance does not meet the criteria for (a) 

assignation of the Risk Phrase R66 in Annex VI of Directive 

67/548/EEC or (b) mild skin irritation according to the criteria laid 

down in Annex 1B of this document; 

e. Eye irritation: the substance does not meet the criteria for “mildly 

irritating to eyes” according to the criteria laid down in Annex 1B of 

this document; 

 

1 Comprising: an absence of clinical signs of toxicity during the post-dosing observation period, no 

treatment-related body weight changes, no macroscopic findings at autopsy and no microscopic findings in 

cases where histopathological investigations have been undertaken. 
f. Sensitisation: no evidence of sensitisation potential from structural 

alerts, in animal tests (no evidence of a positive response in any 

animal tested) and no human evidence of sensitisation potential (no 

human cases of sensitisation reported); 

g. Repeated dose toxicity by the oral route: no evident toxicity2 at ≤ 500 

mg/kg/day (NOAEL) in the case of a 90-day study3. Results from 

longer-term (e.g. 2-year) studies should be evaluated by the applicant 

on a case-by-case basis using this criterion as a guide. For the 

purpose of reviewing current Annex IV entries, if only results from 

short-term studies (e.g. 28 day) are available, then these data should 

be evaluated on a case-by-case basis using this criterion as a guide; 

h. Repeated dose toxicity by the dermal route: no evident toxicity3 at 

≤ 1000 mg/kg/day (NOAEL) in the case of a 90-day study4. Results 

from longer-term studies should be evaluated by the applicant on a 

case-by-case basis using this criterion as a guide. For the purpose of 

reviewing current Annex IV entries, if only results from short-term 

studies (e.g. 28 day) are available, then these data should be 

evaluated on a case-by-case basis using this criterion as a guide; 

i. Repeated dose toxicity by the inhalation route: no evident toxicity3 at 

≤ 2.5 mg/litre/6h/day (NOAEL) in the case of a 90-day study.4

Results from longer-term studies should be evaluated by the applicant 

on a case-by-case basis using this criterion as a guide. For the 

purpose of reviewing current Annex IV entries, if only results from 

short-term studies (e.g. 28 day) are available, then these data should 

be evaluated on a case-by-case basis using this criterion as a guide; 

j. Carcinogenicity: no evidence of carcinogenic potential based on 

available data and application of relevant (Q)SAR models or other 

structural alerts; 

k. Mutagenicity: no evidence of mutagenic potential in vitro or in vivo 

nor from the application of relevant (Q)SAR models or other 

structural alerts; 

l. Reproductive toxicity: no evidence of reproductive toxicity at 

≤ 1000 mg/kg/day by the oral route, at ≤ 2000 mg/kg/day by the 

dermal route or at ≤ 20 mg/litre/6h/day for gases or vapours or 

≤ 5 mg/litre/6h/day for aerosols or particulates (limit tests) by the 

 

2 Comprising: an absence of clinical signs of toxicity during the period of the study, e.g., including 

behavioural changes, no treatment-related body weight or food consumption changes, no macroscopic 

findings at autopsy, no treatment-related effects on organ weights, clinical chemical or haematological 

parameters or urinalysis, no treatment-related microscopic findings. 

3

 The data set for application for an exemption from registration will normally include a 90-day study 
inhalation route4

, nor from the application of relevant (Q)SAR 

models or other structural alerts; 

m. Harm to breastfed babies: the substance should not interfere or be 

suspected to be able to interfere with lactation, nor should it be a 

substance which may be present in breast milk or be suspected to be 

able to pass over to breast milk; 

n. Narcotic effects: the substance should not cause any signs of CNS 

depression even after prolonged or repeated exposure; 

o. Danger of cumulative effects: the substance should not have been 

shown to accumulate in the human body or be suspected to have 

properties leading to such accumulation. 

6. The substance must not meet any of the screening criteria for PBT or vPvB 

set out in the TGD for the CSA/CSR5 nor must it be on the PBT working 

group list. 

7. The substance shall not be identified or suspected to have endocrine activity 

from in vivo or in vitro tests, nor from the application of relevant (Q)SAR 

models or other structural alerts, which may raise any concern for endocrinedisrupting properties (DG Environment, ENV.D4./ETU/2005/0028r; 

http:/ec.europa.eu/environment/endocrine/documents/final_report_2007.pdf) 

8. The substance shall not be listed in Annex II or Annex III of the Cosmetic 

Directive 76/768/EEC. 

2.3 Ecotoxicological properties 

All the following criteria must be met: 

1. The data specified in section 3 on Information requirements must be 

provided. 

2. The substance does not meet the criteria for classification as dangerous in 

accordance with Directive 67/548/EEC. 

3. The substance does not meet the criteria for a substance of very high concern 

in accordance with Article 57 of REACH. 

4. The intrinsic properties of the substance are well below the criteria for 

classification as dangerous in accordance with Directive 67/548/EEC (using 

all available data), i.e.: 

 

4 There is currently limited scientific basis for the indicated figures for the dermal and inhalation routes. 5

 The TGD for the CSA/CSR is not yet finalised and, thus, the best available draft TGD will be used. 
a. The substance shall have a very low potential to bioaccumulate in 

aquatic species, e.g. fish, i.e. experimentally determined 

bioconcentration factor is < 10. For organic substances an alternative 

criteria of log Pow < 2.0 can be applied. 

b. The substance shall be readily biodegradable (excluding inorganic 

substances) 

c. The aquatic toxicity shall fulfil both of the following criteria: 

i. Acute, short-term EC/LC50 > 1000 mg/L, or > water 

solubility, or no significant adverse effects recorded at 100 

mg/l in acute, short-term aquatic toxicity tests and validated 

QSAR data showing acute effects (EC/LC50) > 1000 mg/l. 

ii. Chronic long-term NOEC > 10 mg/L 

5. The substance must not have adverse effects on terrestrial organisms, 

meaning that no adverse effects are reported in any of the tests required 

under Annex IX of the REACH Regulation at the maximum test 

concentrations prescribed by the respective OECD guidelines. 

6. The substance must not meet any of the screening criteria for PBT or vPvB 

set out in the TGD for the CSA/CSR6

 nor must it be on the PBT working 

group list. 

7. The substance shall not be identified or suspected to have endocrine activity 

from in vivo or in vitro tests, nor from the application of relevant (Q)SAR 

models or other structural alerts, which may raise any concern for endocrinedisrupting properties (DG Environment, ENV.D4./ETU/2005/0028r; 

http:/ec.europa.eu/environment/endocrine/documents/final_report_2007.pdf) 

8. The substance shall not present a risk to the ozone layer, i.e. the substance 

shall not be included in Annex I to EC 2037/2000. 

3 INFORMATION REQUIREMENTS 

The information required in a submission requesting the addition of a substance 

to Annex IV shall be sufficient for an evaluation of the fulfillment of the criteria 

for determining minimum risk because of intrinsic properties. The information 

shall consist of: 

1. The information needed for identification of the substance (as defined in 

REACH Annex VI, section 2). 

 

6

 The TGD for the CSA/CSR is not yet finalised and, thus, the best available draft TGD will be used. 
2. The standard information corresponding to the endpoints set out in 

Annex VII, Annex VIII, Annex IX and Annex X, subject to the following 

clarifications: 

 The specific rules for adaptation provided in column 2 of the 

Annexes apply, in relation to exceptions from the standard 

information requirements listed above except when these are 

based on exposure or risk considerations ; 

 Information is required on all the physicochemical properties of 

the substance according to the requirements in Annexes VII and 

IX with the clarification that information is not required for the 

endpoints 7.2 Melting/freezing point, 7.4 Relative density, 7.6 

Surface tension, 7.15 Stability in organic solvents and identity of 

relevant degradation products, and 7.16 Dissociation constant; 

 Toxicological information is required sufficient to demonstrate 

that the criteria set out in section 2 of this document have been 

met and referring to requirements in Annexes VII-X, as 

appropriate (information according to Annex X is only required 

when such studies are available); 

 Ecotoxicological information sufficient to demonstrate that the 

criteria set out in section 2 of this document have been met and 

referring to requirements in Annexes VII-X, as appropriate, with 

the clarification that a minimum of one long-term toxicity study 

as described in endpoint 9.1 (Annex IX) for the most sensitive 

organism (crustacean or fish) is always required (information 

according to Annex X is only required when such studies are 

available). 

3. All available test data and non-test data on the substance and its known 

metabolites. This includes the information in literature and databases 

and, when applicable, information obtained from (Q)SARs, grouping of 

substances or read-across approach, in vivo and in vitro testing, and 

epidemiological studies, cf. Annex XI section 1. If such information is 

used, in accordance with Annex XI, this must be fully justified and 

documented. In this context, available information from risk and hazard 

assessments performed under international, national and Community 

programmes or legislation as well as voluntary initiatives may be used to 

provide reliable information on intrinsic properties. 

4. Robust study summaries, in accordance with the IUCLID 5 manual and 

the OECD HPV Chemicals Programme Manual shall be provided for a 

minimum of one key study per endpoint for physicochemical, 

toxicological and ecotoxicological properties. If the key study for any 

toxicological or ecotoxicological endpoint is not the study giving rise to 
the highest concern, the use of the particular key study must be fully 

justified and robust study summaries shall be provided for the study or 

studies showing a higher effect that the key study. Full study reports need 

not be submitted but the applicant should be in legitimate possession of, 

or have permission to refer to, the full study report and be able to submit 

it to the European Commission or the contractor upon request. Evidence 

of such rights must be available on request (e.g. ownership, letter of 

access). 

5. When the results submitted are not in accordance with publicly available 

sources (i.e. ESIS, IUCLID,...), the applicant must present scientific 

judgement which justifies that the key studies in the submission are 

superior to the publicly available studies showing different results; as a 

minimum the applicant is requested to review the information in the 

IUCLID database. 

6. The information submitted shall be sufficient to enable a conclusion to be 

reached on the intrinsic hazard of the substance, for each relevant 

endpoint. The information shall be presented clearly and succinctly. 

7. If the general rules for adaptation of the standard testing regime as 

described in Annex XI, sections 1 and 2, have been applied, their use 

must be fully justified. As previously indicated the rules described in 

Annex XI section 3 do not apply as they are based on an exposure 

assessment and, thus, a known use of the substance; consequently 

exposure resulting from unknown future uses cannot be addressed. 

8. Commonly known substances, where there is clear scientific evidence 

that prolonged daily and continuous human and environmental exposure 

does not lead to more than minimum risk may be evaluated case-by-case 

as the information required in Annexes VII to X would not add useful 

data to the already available information. This approach could be 

warranted for substances such as sugar which can be considered to 

constitute a minimum risk even though a full dataset may not be 

available. Waiving of standard information requirements for such 

substances may refer to Annex XI, particularly sections 1.1 (Use of 

existing data) and 1.2 (Weight of evidence). Minimum risk can, however, 

not be concluded based alone on a Community risk assessment not 

resulting in risk management measures being recommended. 

9. If grouping of substances and the read-across approach are applied, in 

accordance with Annex XI section 1.5, this must be fully justified and 

documented. This means that unambiguous identification of the 

substances included in the grouping and information on the endpoints 

where the approach is applied must be clearly provided. 
10. Information need not be provided if testing is not technically possible 

due to the intrinsic physicochemical properties of a substance, cf. Annex 

XI section 2. If waiving of the requirement for information is applied for 

this reason in accordance with Annex XI, it must be fully justified and 

documented. 
4 DOCUMENTATION REQUIREMENTS 

The following documentation requirements must be met: 

1. Submissions to be considered for the inclusion of an additional substance 

in Annex IV shall consist of a dossier including: 

 An overall conclusion from the applicant on whether the 

substance meets the criteria laid down in this document, with 

justification; 

 A conclusion (descriptive and numerical) per endpoint based on 

consideration of the information required; and 

 The information specified in section 3 on ‘Information 

requirements’ and a completed format in accordance with the 

instructions in Appendix 2. 

2. The information in the dossier must be clearly presented in accordance 

with these instructions and the information requirements. The information 

in the dossier should be in English. Any submission with an incomplete or 

unclear dossier will be rejected without further consideration. 

3. If there is publicly available information on the substance or known 

metabolites of the substance, not addressed in the submission, which leads 

to any doubt on the potential risk of the substance, then the submission 

will be rejected without further consideration. 

4. If robust study summaries or other relevant information, e.g. (Q)SAR 

results with clear justification, are not presented in a clear manner for all 

key studies, then the submission will be rejected without further 

consideration. 

5. Submissions to be considered for deletion of a substance in the existing 

Annex IV shall include a dossier containing a conclusion that the 

substance does meet the criteria laid down in this document. 

Documentation and justification shall be provided by completion of the 

relevant sections of the format (Appendix 2). 
5. PROCESS 

5.1 Submissions seeking the addition to or deletion of a substance 

from the existing Annex IV 

Submissions seeking the addition or deletion of an entry to Annex IV shall be submitted 

by 30 November 2007 to the national competent authority of the country in which the 

applicant is based or to one of the following industry associations (CEFIC, CONCAWE, 

REACH Alliance), with a copy to the Commission.7

 

Only one proposal for each substance should be submitted to the Member States and 

industry associations (see above). Due to limited resources and the short timescales 

involved in the review Member States and stakeholders should co-ordinate their efforts to 

achieve this end. Multiple proposals for a substance will be assessed separately rather 

than jointly due to resource constraints (also see point 4.3 above). 

The Member State or industry association to whom the submission was made will screen 

the proposals against the agreed criteria and, if satisfied that the criteria and information 

requirements are fulfilled, forward the submission to the contractor and the Commission8

. 

If a submission does not meet the information requirements or criteria it may be rejected 

by the Member State or industry association. Such rejection shall be communicated to the 

applicant and the Commission9 with a brief justification for such rejection following a 

standard format to be developed by the contractor. If an incomplete submission is not 

rejected by the Member State or industry association then an explanation of why the 

submission does not meet the criteria should be forwarded by the MS or industry 

association concerned to the Commission. 

If one of the criteria is not met the submission to be considered for the inclusion of an 

additional substance in Annex IV will be rejected by the contractor without further 

consideration of other criteria. 

The contractor will evaluate the proposals submitted to it by Member States and the 

industry associations and forward a summary and conclusion on either addition to, or 

deletion from, Annex IV to the Commission. 

The strict deadline for the Member States or industry associations to forward submissions 

satisfying the requirements set out in this document to the contractor and the Commission 

shall be 10 January 2008. 

 

7 ENV-reach-review-annex-IV@ec.europa.eu and ENTR-AnnexIV-review@ec.europa.eu ,

mentioning in the subject line: “Submission of proposal for inclusion in/deletion from Annex IV” 

8

 AnnexIV@dhigroup.com mentioning in the subject line: “Proposal for inclusion in/deletion from 

Annex IV” as well as to ENV-reach-review-annex-IV@ec.europa.eu and ENTR-AnnexIVreview@ec.europa.eu

9 ENV-reach-review-annex-IV@ec.europa.eu and ENTR-AnnexIV-review@ec.europa.eu,

mentioning in the subject line: “Rejected proposal for inclusion in/deletion from Annex IV” 
5.2 Evaluations of substances already in Annex IV 

The existing entries of Annex IV will be reviewed to see if they meet the developed 

criteria. The following approach will be applied: 

 The contractor will collect data according to the information requirements for 

inclusion in Annex IV (see above) from easily accessible data sources, i.e. 

ECOTOX, GESAMP, IUCLID and HSDB. The developed format for submissions 

will be used as far as possible. 

 The contractor will group substances in Annex IV, where possible, so that readacross principles can be used for all substances belonging to the same group. The 

following grouping could be applied: 

1. Sugars (e.g. glucose, L-sorbose) 

2. Saturated aliphatic monocarboxylic acids (e.g. lauric acid, palmitic acid, 

stearic acid) 

3. Fatty acids (e.g. C6-12, C12-14, C12-18, C16-18 saturated fatty acids 

and/or unsaturated fatty acids) 

4. Vegetable oils (e.g. sunflower oil, soybean oil, stafflower oil, linseed oil, 

corn oil) 

5. Glycerides (e.g. C10-18, C12-14, C16-18 and C18 unsaturated, C16-18 

and mono and di-C18 unsaturated) 

6. Unsaturated aliphatic acids and their salts (e.g. oleic acid and potassium 

oleate, stearic acid and sodium stearate, calcium distearate) 

7. Esters (e.g. D-glucitol monostearate from D-glucitol and stearic acid). 

 The contractor will check whether the entries fulfil the data requirements and the 

criteria above. Bearing in mind the historical evidence on substances in Annex IV, 

the burden of proof is directed at identifying evidence of human health or 

environmental effects according to the above criteria. This is as opposed to 

proposals for additions to Annex IV, where the burden of proof is directed at 

demonstrating compliance with the criteria and information requirements 

described in section 2 of this document. 

 Should the contractor find indications in the information assessed leading to the 

conclusion that a substance does not fulfil the criteria the relevant industry 

association(s) shall be informed. They will be given the opportunity to dispute this 

by sending information showing that the substance in question does fulfil the 

criteria for inclusion in Annex IV. 

 The contractor will prepare summaries of the review of the existing entries of 

Annex IV. 
APPENDIX IA 

Criteria10 for identification of hazardous physicochemical properties 

1. Explosive. A substance shall not meet the criteria for any one of the divisions 

1.1, 1.2, 1.3, 1.4 and 1.5, based on Test Series 2 to 8 in part I of the UN 

Recommendations on the Transport of Dangerous Goods, Manual of Tests and 

Criteria according to the following description and the results of the tests laid 

down in Table 1 below: 

(a) Division 1.1 Substances, mixtures and articles which have a mass 

explosion hazard (a mass explosion is one which affects almost the entire 

quantity present virtually instantaneously); 

(b) Division 1.2 Substances, mixtures and articles which have a projection 

hazard but not a mass explosion hazard; 

(c) Division 1.3 Substances, mixtures and articles which have a fire hazard 

and either a minor blast hazard or a minor projection hazard or both, but 

not a mass explosion hazard: 

(i) combustion of which gives rise to considerable radiant heat; or 

(ii) which burn one after another, producing minor blast or projection 

effects or both; 

(d) Division 1.4 Substances, mixtures and articles which present no 

significant hazard: 

– Substances, mixtures and articles which present only a small hazard 

in the event of ignition or initiation. The effects are largely confined 

to the package and no projection of fragments of appreciable size or 

range is to be expected. An external fire shall not cause virtually 

instantaneous explosion of almost the entire contents of the package; 

(e) Division 1.5 Very insensitive substances or mixtures which have a mass 

explosion hazard: 

 

10 These criteria are established via the ADR, “European Agreement Concerning the 

International Carriage of Dangerous Goods by Road’ 2007, which is the legislation applicable to 

transport of dangerous goods in the European Community and in internationally in all countries that are 

signatories to the ADR. The ADR is enacted under the auspices of the United Nations Economic 

Commission for Europe http://www.unece.org/trans/danger/publi/adr/adr_e.html. Further information on 

the criteria and on the test methods to be applied can be obtained from the ADR and/or the UN 

Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria UN 

Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria
– Substances and mixtures which have a mass explosion hazard but are 

so insensitive that there is very little probability of initiation or of 

transition from burning to detonation under normal conditions. 

Table 1 

Tests necessary to apply the criteria for explosives

Category Criteria 

Unstable 

explosives or 

explosives of 

Division 1.1 to 

1.6

For explosives of Divisions 1.1 to 1.5, the following are the core set of tests 

that need to be performed: 

Explosibility: according to UN Test Series 2 (section 12 of the UN 

Recommendations on the Transport of Dangerous Goods, Manual of Tests 

and Criteria). Intentional explosives11 shall not be subject to UN Test 

Series 2. 

Sensitiveness: according to UN Test Series 3 (section 13 of the UN 

Recommendations on the Transport of Dangerous Goods, Manual of Tests 

and Criteria). 

Thermostability: according to UN Test 3(c) (Sub-section 13.6.1 of the UN 

Recommendations on the Transport of Dangerous Goods, Manual of Tests 

and Criteria). 

Further tests are necessary to allocate the correct Division. 

2. Flammable gas. A substance shall not meet the criteria for classification as a 

flammable gas, Category 1 or Category 2, laid out in Table 2 below, 

Table 2 

Criteria for flammable gases 

Category Criteria 

1 

Gases, which at 20°C and a standard pressure of 101.3 kPa: 

(a) are ignitable when in a mixture of 13% or less by volume in air; 

or 

(b) have a flammable range with air of at least 12 percentage points 

regardless of the lower flammable limit. 

2 Gases, other than those of Category 1, which, at 20°C and a standard 

pressure of 101.3 kPa, have a flammable range while mixed in air. 

Note 1: 

Ammonia and methyl bromide are regarded as flammable gases (special cases). 

3. Flammable liquid. A substance shall not meet the criteria for a flammable 

liquid, Category 1, Category 2, Category 3 or Category 4, laid out in Table 3 

below. 

 

11 This comprises substances, mixtures and articles which are manufactured with a view to producing 

a practical, explosive or pyrotechnic effect. 
Table 3 

Criteria for flammable liquids 

Category Criteria 

1 Flash point < 23°C and initial boiling point ≤ 35°C 

2 Flash point < 23°C and initial boiling point > 35°C 

3 Flash point ≥ 23°C and ≤ 60°C12

4 Flash point > 60 °C and ≤ 93 °C 

4. Flammable solid. A substance shall not meet the criteria for a Category 1 or 

Category 2 flammable solid, laid out in Table 4 below. 

Table 4 

Criteria for flammable solids 

Category Criteria 

1 

Burning rate test 

Substances other than metal powders: 

(a) wetted zone does not stop fire and 

(b) burning time < 45 seconds or burning rate > 2.2 mm/s 

Metal powders 

burning time ≤ 5 minutes 

2 

Burning rate test 

Substances other than metal powders: 

(a) wetted zone stops the fire for at least 4 minutes and 

(b) burning time < 45 seconds or burning rate > 2.2 mm/s 

Metal powders 

burning time > 5 minutes and ≤ 10 minutes 

5. Oxidising gas. A substance shall not meet the criteria for a Category 1 oxidising 

gas, laid out in Table 5 below. 

Table 5 

Criteria for oxidising gases 

Category Criteria 

1 Any gas which may, generally by providing oxygen, cause or contribute 

to the combustion of other material more than air does. 

 

12 Gas oils, diesel and light heating oils in the flash point range of 55°C to 75°C may be 

regarded as Category 3 for transport. 
6. Oxidising liquid. A substance shall not meet the criteria for a Category 1, 

Category 2 or Category 3 oxidising liquid, laid out in Table 6 below. 

Table 6 

Criteria for oxidising liquids 

Category Criteria 

1 

Any substance or mixture which, in the 1:1 mixture, by mass, of 

substance and cellulose tested, spontaneously ignites; or the mean 

pressure rise time of a 1:1 mixture, by mass, of substance and cellulose is 

less than that of a 1:1 mixture, by mass, of 50% perchloric acid and 

cellulose 

2 

Any substance or mixture which, in the 1:1 mixture, by mass, of 

substance and cellulose tested, exhibits a mean pressure rise time less 

than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 

40% aqueous sodium chlorate solution and cellulose; and the criteria for 

Category 1 are not met 

3 

Any substance or mixture which, in the 1:1 mixture, by mass, of 

substance and cellulose tested, exhibits a mean pressure rise time less 

than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 

65% aqueous nitric acid and cellulose; and the criteria for Category 1 and 

2 are not met 

7. Oxidising solid. A substance shall not meet the criteria for a Category 1, Category 2 

or Category 3 oxidising solid, laid out in Table 7 below. 

Table 7 

Criteria for oxidising solids 

Category Criteria 

1 

Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose 

ratio (by mass) tested, exhibits a mean burning time less than the mean 

burning time of a 3:2 mixture, by mass, of potassium bromate and 

cellulose. 

2 

Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose 

ratio (by mass) tested, exhibits a mean burning time equal to or less 

than the mean burning time of a 2:3 mixture (by mass) of potassium 

bromate and cellulose and the criteria for Category 1 are not met. 

3 

Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose 

ratio (by mass) tested, exhibits a mean burning time equal to or less 

than the mean burning time of a 3:7 mixture (by mass) of potassium 

bromate and cellulose and the criteria for Categories 1 and 2 are not 

met. 
8. Corrosive to metals. A substance shall not meet the criteria for corrosive to metals, 

Category 1, laid out in Table 8 below. 

Table 8 

 Criteria for substances corrosive to metals 

Category Criteria 

1 Corrosion rate on steel or aluminium surfaces exceeding 6.25 

mm per year at a test temperature of 55 °C. 

 

9. Self-reactive substance. A substance shall not meet the criteria for a self-reactive 

substance, Types A to F, according to the criteria laid out in Table 9. 

Table 9 

Criteria for self-reactive substances 

(a) Any self-reactive substance which can detonate or deflagrate rapidly, as packaged, shall 

be defined as self-reactive substance TYPE A; 

(b) Any self-reactive substance possessing explosive properties and which, as packaged, 

neither detonates nor deflagrates rapidly, but is liable to undergo a thermal explosion in 

that package shall be defined as self-reactive substance TYPE B; 

(c) Any self-reactive substance possessing explosive properties when the substance or 

mixture as packaged cannot detonate or deflagrate rapidly or undergo a thermal explosion 

shall be defined as self-reactive substance TYPE C; 

(d) Any self-reactive substance which in laboratory testing: 

(i) detonates partially, does not deflagrate rapidly and shows no violent effect when 

heated under confinement; or 

(ii) does not detonate at all, deflagrates slowly and shows no violent effect when heated 

under confinement; or 

(iii) does not detonate or deflagrate at all and shows a medium effect when heated under 

confinement; 

shall be defined as self-reactive substance TYPE D; 

(e) Any self-reactive substance which, in laboratory testing, neither detonates nor deflagrates 

at all and shows low or no effect when heated under confinement shall be defined as selfreactive substance TYPE E; 

(f) Any self-reactive substance which, in laboratory testing, neither detonates in the cavitated 

state nor deflagrates at all and shows only a low or no effect when heated under 

confinement as well as low or no explosive power shall be defined as self-reactive 

substance TYPE F; 
10. Pyrophoric liquid. A substance shall not meet the criteria for pyrophoric liquid, 

Category 1, laid out in Table 10 below.

Table 10 

Criteria for pyrophoric liquids 

Category Criteria 

1 

The liquid ignites within 5 min when added to an inert carrier and 

exposed to air, or it ignites or chars a filter paper on contact with air 

within 5 min. 

 

11. Pyrophoric solid, A substance shall not meet the criteria for pyrophoric solid, 

Category 1, laid out in Table 11 below. 

Table 11 

Criteria for pyrophoric solids 

Category Criteria 

1 The solid ignites within 5 minutes of coming into contact with air. 

12. Self-heating substance. A substance shall not meet the criteria for a self-heating 

substance, Category 1 or Category 2, laid out in Table 12 below. 

Table 2.11.1 

Criteria for self-heating substances and mixtures 

Category Criteria 

1 A positive result is obtained in a test using a 25 mm sample cube at 140°C 

2 

(a) It does not meet the criteria for Category 1; and 

 a positive result is obtained in a test using a 100 mm sample cube at 140°C; 

Exemptions from (a) for classification in Category 2 

(i) a negative result is obtained in a test using a 100 mm cube sample at 100°C 

and

the unit volume of the substance is 450 litres or less; 

(ii) a negative result is obtained in a test using a 100 mm cube sample at 120°C 

and

the unit volume of the substance is 3 m3 or less; 

(b) It does not meet the criteria for Category 1; and 

a positive result is obtained in a test using a 100 mm sample cube at 140°C; and

it is not a substances exempted under (a), that gives a positive result in a test 

using a 100 mm cube sample at 100°C; 

13. Substance which in contact with water emits flammable gas. A substance shall not

meet the criteria for a substance which in contact with water emits flammable gas, 

Category 1 Category 2 or Category 3, laid out in Table 13 below.
Table 13 

Criteria for substances or mixtures which in contact with water emit flammable 

gases 

Category Criteria 

1 

Any substance or mixture which reacts vigorously with water at 

ambient temperatures and demonstrates generally a tendency for the 

gas produced to ignite spontaneously, or which reacts readily with 

water at ambient temperatures such that the rate of evolution of 

flammable gas is equal to or greater than 10 litres per kilogram of 

substance over any one minute. 

2 

Any substance or mixture which reacts readily with water at ambient 

temperatures such that the maximum rate of evolution of flammable 

gas is equal to or greater than 20 litres per kilogram of substance per 

hour, and which does not meet the criteria for Category 1. 

3 

Any substance or mixture which reacts slowly with water at ambient 

temperatures such that the maximum rate of evolution of flammable 

gas is equal to or greater than 1 litre per kilogram of substance per 

hour, and which does not meet the criteria for Categories 1 and 2. 

 

14. Organic peroxide. A substance shall not meet the criteria for an organic peroxide of 

Types A to F, laid out in Table 14 below. 

Table 14 

Criteria for organic peroxides

(a) Any organic peroxide which, as packaged, can detonate or deflagrate 

rapidly shall be defined as organic peroxide TYPE A; 

(b) Any organic peroxide possessing explosive properties and which, as 

packaged, neither detonates nor deflagrates rapidly, but is liable to undergo 

a thermal explosion in that package shall be defined as organic peroxide 

TYPE B; 

(c) Any organic peroxide possessing explosive properties when the substance 

or mixture as packaged cannot detonate or deflagrate rapidly or undergo a 

thermal explosion shall be defined as organic peroxide TYPE C; 
 (d) Any organic peroxide which in laboratory testing: 

(i) Detonates partially, does not deflagrate rapidly and shows no violent 

effect when heated under confinement; or 

(ii) Does not detonate at all, deflagrates slowly and shows no violent 

effect when heated under confinement; or 

(iii) Does not detonate or deflagrate at all and shows a medium effect 

when heated under confinement; 

shall be defined as organic peroxide TYPE D; 

(e) Any organic peroxide which, in laboratory testing, neither detonates nor 

deflagrates at all and shows low or no effect when heated under 

confinement shall be defined as organic peroxide TYPE E; 

(f) Any organic peroxide which, in laboratory testing, neither detonates in the 

cavitated state nor deflagrates at all and shows only a low or no effect 

when heated under confinement as well as low or no explosive power shall 

be defined as organic peroxide TYPE F; 
APPENDIX IB 

Criteria13 for identification of mild skin and eye irritants, based on the results of in 

vivo testing 

Mild skin irritant: A mean value of ≥ 1.5 - < 2.3 has been obtained for 

erythema/eschar or for oedema from gradings in at least 2 of 3 

tested animals from grades at 24, 48 and 72 hours or, if reactions 

are delayed, from grades on 3 consecutive days after the onset of 

skin reactions, and the substance has not been classified as a skin 

irritant based on the criteria laid down in Annex VI of Directive 

67/548/EEC. 

Mild eye irritant: the substance meets the criteria laid down in Annex VI of 

Directive 67/548/EEC for classification as an eye irritant, namely 

produces at least in 2 of 3 tested animals a positive response of: 

 corneal opacity > 1 and/or 

 iritis > 1, and/or 

 conjunctival redness > 2, and/or 

 conjunctival oedema (chemosis) > 2 

 - calculated as the mean scores following grading at 24, 48 

and 72 hours after installation of the test material, 

BUT

 - which fully reverses within an observation period of 7 days 

 

13 These criteria reflect the criteria established for mild skin irritants (category 3) Globally 

Harmonised System of Classification and Labelling of Chemicals (GHS) 

(http://www.unece.org/trans/danger/publi/ghs/ghs_rev00/00files_e.html) 
APPENDIX 2 

Format of Dossier 

The dossier shall be completed by the applicant seeking the addition of a substance to 

Annex IV, or by applicants advocating for a deletion of a substance from the existing 

Annex IV. 

Table 1 shall contain a clear identification of the applicant and substance in accordance 

with the substance identifiers described in Annex VI, section 1 and 2. 

Table 2 shall contain the applicant’s conclusions (descriptive and numerical) on 

minimum risk based on the intrinsic properties of the substance, which shall be 

summarised for the main end-points. 

Table 3 shall contain a clear identification of substances for which data have been used in 

accordance with the rules for grouping or read-across approach (set out in Annex XI, 

section 1.5). 

Table 4 shall contain an overview of the information submitted by the applicant, 

including a confirmation that the information requirements in section 3 of the criteria 

document have been met, confirmation of compliance with the endpoint-specific criteria, 

values for each endpoint, and indications of adaptations according to column 2 of 

Annexes VII-X and Annex XI section 1 and 2, if appropriate. 

More detailed information shall be provided in Annexes A-C of the submission (see 

below). 

The dossier shall include robust study summaries in Annex A of the submission. 

A description and justification shall be included in Annex B of the submission, if the 

specific rules for adaptation of the standard information requirements (column 2 in 

Annexes VII-X) have been applied. 

A description and justification shall be included in Annex C of the submission, if the 

general rules for adaptation of the standard testing regime set out in Annexes VII-X have 

been applied (in accordance with Annex XI, sections 1 and 2). 

Table 1 Identification of applicant and substance (according to Annex VI, 

section 1 and 2) 

1.1 Applicant

1.1.1 Name, address, telephone number, fax 

number and e-mail address 
1.1.2. Contact person 

2.1. Name or other identifier of each substance 

2.1.1. Name(s) in the IUPAC nomenclature or 

other international chemical name(s) 

2.1.2. Other names (usual name, trade name, 

abbreviation) 

2.1.3. EINECS or ELINCS number (if 

available and appropriate) 

2.1.4. CAS name and CAS number (if 

available) 

2.1.5. Other identity code (if available) 

2.2. Information related to molecular and structural formula of each substance 

2.2.1. Molecular and structural formula 

(including SMILES notation, if available) 

2.2.2 Information on optical activity (if 

applicable and appropriate) 

2.2.3. Molecular weight or molecular weight 

range 

2.3. Composition of each substance 

2.3.1. Degree of purity (%) 

2.3.2. Nature of impurities, including isomers 

and by-products 

2.3.3. Percentage of (significant) main 

impurities 

2.3.4. Nature and order of magnitude (......ppm, 

......%) of any additives (e.g. stabilising 

agents or inhibitors) 

2.3.5. Spectral data (ultra-violet, infra-red, 

nuclear magnetic resonance or mass spectrum) 

2.3.6. High-pressure liquid chromatogram, gas 

chromatogram 

2.3.7. Description of the analytical methods or 

the appropriate bibliographical references 

for the identification of the substance and, 

where appropriate, for the identification 

of impurities and additives. This information 

shall be sufficient to allow the methods 

to be reproduced. 
Conclusion on minimum risk: 

The table shall be completed by the applicant. For each of the endpoints listed below, 

conclusions on minimum risk based on the intrinsic properties of the substance shall be 

provided (descriptive text relating the appropriate data to the criterion for the endpoints). 

The results of relevant robust study summaries attached at Annex A shall also be 

summarised. 

Table 2 Conclusion on minimum risk 

Ref. 

No.

Properties Summary 

Physicochemical properties

Explosive 

properties

Flammability 

Oxidising 

properties 

Corrosive to 

metals

Self-reactive 

substance

Pyrophoric 

properties;

Self-heating 

substance

Substance which 

in contact with 

water emits 

flammable gas

Organic peroxides

 Toxicological information 
8.1 Skin irritation 

8.2 Eye irritation 

8.3 Skin sensitisation 

8.4 Mutagenicity 

8.5 Acute toxicity 

8.6 Repeated dose 

toxicity 

8.7 Reproductive toxicity 

8.8 Carcinogenicity 

8.9 Toxicokinetics 

 Ecotoxicological information

9.1 Aquatic toxicity 

9.2 Degradation 

9.3 Fate and behaviour in 

the environment 

Please also complete the following: 

 YES NO 

Is the substance, due to its intrinsic properties, 

fulfilling the criteria for PBT and/or vPvB, or is it 

listed in the PBT working group list? 

 

Is the substance identified or suspected to have 
endocrine disrupting properties? 

Is the substance listed in Annex II or Annex III of the 

Cosmetic Directive 76/768/EEC? 

 

Is the substance listed in Annex I of EC 2037/2000? 
Grouping of substances or read-across approach 

It shall be stated if grouping of substances or read-across approach has been applied. The 

identity of the substances or group of substances used in the grouping or read-across shall 

be stated below. Identification of the substance for which data have been used according 

to the rules for grouping of substances or read-across approach shall be given by 

substance name, CAS number and EINECS or ELINCS number. The reference numbers 

from Annexes VII-X should be used to indicate the endpoints for which grouping or readacross has been applied. 

Justification for the grouping or read-across shall be given at Annex C of this dossier; this 

documentation shall be clearly marked with the substance identity and relevant annex 

number. 

Table 3 Identification of substances for which grouping or read-across 

approach has been applied 

Identity of substance or group of substances given 

as IUPAC name, CAS No. and EINECS or 

ELINCS 

Endpoints for which grouping or read-across 

has been applied (Use reference numbers from 

Annexes VII-X) 

 
Table of information: 

This table shall be completed by the applicant. Table 4 Overview of information in the submission Annex Ref End Points Information 

as required in section 3 of the criteria document have been submitted 

Compliance with criteria confirmed 

Value of endpoints 

Adaptation according to column 2 of Annexes VII-X applied 

 Yes/No or 

NA according to column 2 Annex VIIX or Annex XI 

Yes/No/NA* * not appropriate 

Unit has to be given for each individual endpoint 

Yes/No Justification is to be annexed separate documentation 

 Physicochemical properties VII 7.1 State of the substance VII 7.3 Boiling point VII 7.5 Vapour pressure VII 7.7 Water solubility VII 7.8 Partition coefficient noctanol/water VII 7.9 Flash point VII 7.10 Flammability VII 7.11 Explosive properties 
Annex Ref End Points Information 

as required in section 3 of the criteria document have been submitted 

Compliance with criteria confirmed 

Value of endpoints 

Adaptation according to column 2 of Annexes VII-X applied 

VII 7.12 Self-ignition temperature VII 7.13 Oxidising properties VII 7.14 Granulometry IX 7.17 Viscosity  Toxicological information VII 8.1 Skin irritation VIII 8.1.1 In vivo skin irritation VII 8.2 Eye irritation VIII 8.2.1 In vivo eye irritation VII 8.3 Skin sensitisation VII 8.4 Mutagenicity VII 8.4.1 In vitro gene mutation in bacteria VIII 8.4.2 In vitro cytogenicity study in 

mammalian cells or in vitro micronucleus study 

VIII 8.4.3 In vitro gene mutation study in 

mammalian cells 

VII 8.5 Acute toxicity VII 8.5.1 By oral route VIII 8.5.2 By inhalation VIII 8.5.3 By dermal route VIII 8.6 Repeated dose toxicity VIII 8.6.1 Short-term repeated dose toxicity 

study (28 days) 

IX 8.6.2 Sub-chronic toxicity study (90 
Annex Ref End Points Information 

as required in section 3 of the criteria document have been submitted 

Compliance with criteria confirmed 

Value of endpoints 

Adaptation according to column 2 of Annexes VII-X applied 

day) 

VIII 8.7 Reproductive toxicity VIII 8.7.1 Screening for 

reproductive/developmental toxicity 

IX 8.7.2 Pre-natal development toxicity 

study 

IX 8.7.3 Two-generation reproductive 

toxicity study 

X 8.7.2 Developmental toxicity study (if 

available) 

X 8.7.3 Two-generation reproductive 

toxicity study (if available) 

X 8.9.1 Carcinogenicity study (if 

available) 

VIII 8.8 Toxicokinetics VIII 8.8.1 Assessment of the toxicokinetic 

behaviour of the substance to the extent that can be derived from relevant available information 

 Ecotoxicological information VII 9.1 Aquatic toxicity VII 9.1.1 Short term toxicity testing on 

invertebrates (Daphnia) 
Annex Ref End Points Information 

as required in section 3 of the criteria document have been submitted 

Compliance with criteria confirmed 

Value of endpoints 

Adaptation according to column 2 of Annexes VII-X applied 

VII 9.1.2 Growth inhibition study aquatic 

plants (algae) 

VIII 9.1.3 Short term toxicity testing on fish VIII 9.1.4 Activated sludge respiration 

inhibition test 

IX 9.1.5 Long term toxicity testing on 

invertebrates (Daphnia) 

IX 9.1.6 Long term toxicity testing on fish IX 9.1.6.1 Fish early-life stage (FELS) 

toxicity test 

IX 9.1.6.2 Fish short-term toxicity test on 

embryo and sac-fry stages 

IX 9.1.6.3 Fish, juvenile growth test VII 9.2 Degradation VII 9.2.1 Biotic VII 9.2.1.1 Ready biodegradability IX 9.2.1.2 Simulation testing on ultimate 

degradation in surface water 

IX 9.2.1.3 Soil simulation testing IX 9.2.1.4 Sediment simulation testing VIII 9.2.2 Abiotic VIII 9.2.2.1 Hydrolysis as a function of pH IX 9.2.3 Identification of degradation 

products 

VIII 9.3 Fate and behaviour in the 
Annex Ref End Points Information 

as required in section 3 of the criteria document have been submitted 

Compliance with criteria confirmed 

Value of endpoints 

Adaptation according to column 2 of Annexes VII-X applied 

environment 

VIII 9.3.1 Adsorption/desorption screening IX 9.3.2 Bioaccumalation in aquatic 

species, preferable fish 

IX 9.3.3 Further information on 

adsorption/desorption 

X 9.3.4 Further information on the 

environmental fate and behaviour of the substance and/or the degradation products (if available) 

IX 9.4 Effects on terrestrial organisms IX 9.4.1 Short-term toxicity in 

invertebrates 

IX 9.4.2 Effects on soil micro-organisms IX 9.4.3 Short-term toxicity to plants X 9.4.4 Long-term toxicity testing on 

invertebrates (if available) 

X 9.4.6 Long-term toxicity testing on 

plants (if available) 

X 9.5.1 Long-term toxicity to sediment 

organisms (if available) 

X 9.6.1 Long-term or reproductive 

toxicity to birds (if available) 
36

Annex A Robust study summaries 

Robust study summaries shall be included in Annex A and shall be clearly marked with 

the substance name and the reference number of the relevant section in Annexes VII-X. 
37

Annex B Adaptation according to column 2 of Annex VII-X 

A description and justification shall be included in Annex B, if the specific rules for 

adaptation of the standard information requirements (column 2 in Annexes VII-X) have 

been applied. The description shall clearly indicate the substance name and the reference 

number(s) for the information requirements in Annexes VII-X, where adaptations have 

been applied. 
38

Annex C Adaptation according to Annex XI Section 1 or 2 

A description and justification shall be included in Annex C, if the general rules for 

adaptation of the standard testing regime set out in Annexes VII-X have been applied (in 

accordance with Annex XI, sections 1 and 2). The description shall clearly indicate the 

substance name and the reference number(s) for the information requirements in Annexes 

VII-X, where adaptations have been applied.