radioactive substances within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation ( 1 );

substances, on their own, in a ►M3  mixture ◄ or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;

non-isolated intermediates;

the carriage of dangerous substances and dangerous substances in dangerous ►M3  mixtures ◄ by rail, road, inland waterway, sea or air.

Community workplace and environmental legislation, including Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work ( 3 ), Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control ( 4 ); Directive 98/24/EC, Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy ( 5 ) and Directive 2004/37/EC;

Directive 76/768/EEC as regards testing involving vertebrate animals within the scope of that Directive.

in medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products ( 6 ) and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 7 );

in food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:

medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC;

cosmetic products as defined in Directive 76/768/EEC;

medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and ►M3  mixtures ◄ which ensure the same level of information provision and protection as Directive 1999/45/EC;

food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:

substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties;

substances covered by Annex V, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation;

substances on their own or in ►M3  mixtures ◄ , registered in accordance with Title II, exported from the Community by an actor in the supply chain and re-imported into the Community by the same or another actor in the same supply chain who shows that:

substances, on their own, in ►M3  mixtures ◄ or in articles, which have been registered in accordance with Title II and which are recovered in the Community if:

Chapter 1 of Title II, with the exception of Articles 8 and 9; and

Title VII.

the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s);

the total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year.

the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

the substance is intended to be released under normal or reasonably foreseeable conditions of use.

the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

the substance is present in those articles above a concentration of 0,1  % weight by weight (w/w).

the identity and contact details of the producer or importer as specified in section 1 of Annex VI, with the exception of their own use sites;

the registration number(s) referred to in Article 20(1), if available;

the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI;

the classification of the substance(s) as specified in sections 4.1 and 4.2 of Annex VI;

a brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex VI and of the uses of the article(s);

the tonnage range of the substance(s), such as 1 to 10 tonnes, 10 to 100 tonnes and so on.

the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;

the Agency has grounds for suspecting that:

the substance is not subject to paragraph 1.

the identity of the manufacturer or importer or producer of articles as specified in section 1 of Annex VI;

the identity of the substance, as specified in section 2 of Annex VI;

the classification of the substance as specified in section 4 of Annex VI, if any;

the estimated quantity as specified in section 3.1 of Annex VI;

the list of customers referred to in paragraph 1, including their names and addresses.

it would be disproportionately costly for him to submit this information jointly; or

submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or

he disagrees with the lead registrant on the selection of this information.

the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of one tonne or more per year per manufacturer or importer;

the information on physicochemical properties specified in Annex VII, section 7 for phase-in substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III;

the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer;

the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annex IX for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer;

the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1 000 tonnes or more per year per manufacturer or importer.

the cut-off value referred to in Article 11, paragraph 3 of Regulation (EC) No 1272/2008;

0,1  % weight by weight (w/w), if the substance meets the criteria in Annex XIII to this Regulation.

human health hazard assessment;

physicochemical hazard assessment;

environmental hazard assessment;

persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

hazard class 4.1;

hazard class 5.1,

exposure assessment including the generation of exposure scenario(s) (or the identification of relevant use and exposure categories if appropriate) and exposure estimation;

risk characterisation.

in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food ( 14 );

in cosmetic products within the scope of Directive 76/768/EEC.

the identity of the manufacturer as specified in Section 1 of Annex VI;

the identity of the intermediate as specified in Sections 2.1 to 2.3.4 of Annex VI;

the classification of the intermediate as specified in Section 4 of Annex VI;

any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted;

a brief general description of the use, as specified in Section 3.5 of Annex VI;

details of the risk management measures applied.

the identity of the manufacturer or importer as specified in Section 1 of Annex VI;

the identity of the intermediate as specified in Sections 2.1 to 2.3.4 of Annex VI;

the classification of the intermediate as specified in Section 4 of Annex VI;

any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted;

a brief general description of the use, as specified in Section 3.5 of Annex VI;

information on risk management measures applied and recommended to the user in accordance with paragraph 4.

the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage;

procedural and control technologies shall be used that minimise emission and any resulting exposure;

only properly trained and authorised personnel handle the substance;

in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered;

in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures;

substance-handling procedures are well documented and strictly supervised by the site operator.

it would be disproportionately costly for him to submit this jointly; or

submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or

he disagrees with the lead registrant on the selection of this information.

the registration dossier together with the submission or registration number;

the submission or registration date;

the result of the completeness check; and

any request for further information and deadline set in accordance with the third subparagraph of paragraph 2.

any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address;

any change in the composition of the substance as given in Section 2 of Annex VI;

changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import;

new identified uses and new uses advised against as in Section 3.7 of Annex VI for which the substance is manufactured or imported;

new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report;

any change in the classification and labelling of the substance;

any update or amendment of the chemical safety report or Section 5 of Annex VI;

the registrant identifies the need to perform a test listed in Annex IX or Annex X, in which cases a testing proposal shall be developed;

any change in the access granted to information in the registration.

phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching one tonne or more per year per manufacturer or per importer, at least once after 1 June 2007;

phase-in substances classified as very toxic to aquatic organisms which may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC, and manufactured in the Community or imported in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007;

phase-in substances manufactured in the Community or imported, in quantities reaching 1 000 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007.

his identity as specified in Section 1 of Annex VI, with the exception of the use sites;

the identity of the substance, as specified in Section 2 of Annex VI;

which information requirements would require new studies involving vertebrate animals to be carried out by him;

which information requirements would require other new studies to be carried out by him.

shall, in the case of information involving tests on vertebrate animals; and

may, in the case of information not involving tests on vertebrate animals,

the name of the substance as specified in Section 2 of Annex VI, including its EINECS and CAS number or, if not available, any other identity codes;

his name and address and the name of the contact person and, where appropriate, the name and address of the person representing him in accordance with Article 4 as specified in Section 1 of Annex VI;

the envisaged deadline for the registration and the tonnage band;

the name(s) of substance(s) as specified in Section 2 of Annex VI, including their EINECS and CAS number or, if not available, any other identity codes, for which the available information is relevant for the application of Sections 1.3 and 1.5 of Annex XI.

facilitate, for the purposes of registration, the exchange of the information specified in Article 10(a) (vi) and (vii) between potential registrants, thereby avoiding the duplication of studies; and

agree classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants.

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;

hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;

hazard class 4.1;

hazard class 5.1.

a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust study summary if required by Annex I;

a decision in accordance with point (a), but modifying the conditions under which the test is to be carried out;

a decision in accordance with points (a), (b) or (d) but requiring registrant(s) or downstream user(s) to carry out one or more additional tests in cases of non-compliance of the testing proposal with Annexes IX, X and XI;

a decision rejecting the testing proposal;

a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them.

that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirements of Articles 10, 12 and 13 and with Annexes III and VI to X;

that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI;

that any required chemical safety assessment and chemical safety report comply with the requirements of Annex I and that the proposed risk management measures are adequate;

that any explanation(s) submitted in accordance with Article 11(3) or Article 19(2) have an objective basis.

the dossier contains information in Article 10(a)(iv), (vi) and/or (vii) submitted separately as per Article 11(3); or

the dossier is for a substance manufactured or imported in quantities of one tonne or more per year and does not meet the requirements of Annex VII applying under either Article 12(1)(a) or (b), as the case may be; or

the dossier is for a substance listed in the Community rolling action plan referred to in Article 44(2).

by 1 December 2012 for all registrations received by 1 December 2010 containing proposals for testing in order to fulfil the information requirements in Annexes IX and X;

by 1 June 2016 for all registrations received by 1 June 2013 containing proposals for testing in order to fulfil the information requirements in Annex IX only;

by 1 June 2022 for any registrations containing testing proposals received by 1 June 2018.

hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;

exposure information;

tonnage, including aggregated tonnage from the registrations submitted by several registrants.

where the competent authority prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information;

where the exposure to the substance manufactured or imported by the registrant(s), or to the substance in the article produced or imported by the registrant(s), or to the substance used by the downstream user(s) contributes significantly to that risk.

the use(s) of that substance on its own or in a ►M3  mixture ◄ or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with Articles 60 to 64; or

the use(s) of that substance on its own or in a ►M3  mixture ◄ or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been exempted from the authorisation requirement in Annex XIV itself in accordance with Article 58(2); or

the date referred to in Article 58(1)(c)(i) has not been reached; or

the date referred to in Article 58(1)(c)(i) has been reached and he made an application 18 months before that date but a decision on the application for authorisation has not yet been taken; or

in cases where the substance is placed on the market, authorisation for that use has been granted to his immediate downstream user.

uses in plant protection products within the scope of Directive 91/414/EEC;

uses in biocidal products within the scope of Directive 98/8/EC;

use as motor fuels covered by Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels ( 22 );

uses as fuel in mobile or fixed combustion plants of mineral oil products and use as fuels in closed systems.

uses in cosmetic products within the scope of Directive 76/768/EEC;

uses in food contact materials within the scope of Regulation (EC) No 1935/2004.

for substances referred to in Article 57(d), (e) and (f), below a concentration limit of 0,1  % weight by weight (w/w);

for all other substances, below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.

the identity of the substance as specified in Section 2 of Annex VI;

the intrinsic property (properties) of the substance referred to in Article 57;

transitional arrangements:

review periods for certain uses, if appropriate;

uses or categories of uses exempted from the authorisation requirement, if any, and conditions for such exemptions, if any.

PBT or vPvB properties; or

wide dispersive use; or

high volumes.

substances meeting the criteria in Article 57(a), (b), (c) or (f) for which it is not possible to determine a threshold in accordance with Section 6.4 of Annex I;

substances meeting the criteria in Article 57(d) or (e);

substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties.

the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;

the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;

the analysis of the alternatives submitted by the applicant under Article 62(4)(e) or any substitution plan submitted by the applicant under Article 62(4)(f), and any third party contributions submitted under Article 64(2);

available information on the risks to human health or the environment of any alternative substances or technologies.

whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures;

the technical and economic feasibility of alternatives for the applicant.

the person(s) to whom the authorisation is granted;

the identity of the substance(s);

the use(s) for which the authorisation is granted;

any conditions under which the authorisation is granted;

the time-limited review period;

any monitoring arrangement.

the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio-economic impact; or

new information on possible substitutes becomes available.

the identity of the substance(s), as referred to in Section 2 of Annex VI;

the name and contact details of the person or persons making the application;

a request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in ►M3  mixtures ◄ and/or the incorporation of the substance in articles, where this is relevant;

unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV;

an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate information about any relevant research and development activities by the applicant;

where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant.

a socio-economic analysis conducted in accordance with Annex XVI;

a justification for not considering risks to human health and the environment arising either from:

Committee for Risk Assessment: an assessment of the risk to human health and/or the environment arising from the use(s) of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives;

Committee for Socio-economic Analysis: an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application, when an application is made in accordance with Article 62 and of any third party contributions submitted under paragraph 2 of this Article.

comments on dossiers and the suggested restrictions;

a socio-economic analysis, or information which can contribute to one, of the suggested restrictions, examining the advantages and drawbacks of the proposed restrictions. It shall conform to the requirements in Annex XVI.