Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance

Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or the privacy or safety of the persons concerned:

• (a) details of the full composition of a biocidal product;

• (b) the precise tonnage of the active substance or biocidal product manufactured or made available on the market;

• (c) links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product;

• (d) names and addresses of persons involved in testing on vertebrates.

However, where urgent action is essential to protect human health, animal health, safety or the environment or for other reasons of overriding public interest, the Agency or the competent authorities shall disclose the information referred to in this paragraph.

• (a) the name and address of the authorisation holder;

• (b) the name and address of the biocidal product manufacturer;

• (c) the name and address of the active substance manufacturer;

• (d) the content of the active substance or substances in the biocidal product and the name of the biocidal product;

• (e) physical and chemical data concerning the biocidal product;

• (f) any methods for rendering the active substance or biocidal product harmless;

• (g) a summary of the results of the tests required pursuant to Article 20 to establish the product’s efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance;

• (h) recommended methods and precautions to reduce dangers from handling, transport and use as well as from fire or other hazards;

• (i) safety data sheets;

• (j) methods of analysis referred to in Article 19(1)(c);

• (k) methods of disposal of the product and of its packaging;

• (l) procedures to be followed and measures to be taken in the case of spillage or leakage;

• (m) first aid and medical advice to be given in the case of injury to persons.

Article 67

Electronic public access

• (a) where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature;

• (b) if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances;

• (c) the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1);

• (d) physicochemical endpoints and data on pathways and environmental fate and behaviour;

• (e) the result of each toxicological and ecotoxicological study;

• (f) acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI;

• (g) the guidance on safe use provided in accordance with Annexes II and III;

• (h) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II.

• (a) the terms and conditions of the authorisation;

• (b) the summary of the biocidal product characteristics; and

• (c) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 5.2 of Title 2 of Annex III.

• (a) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous;

• (b) the study summaries or robust study summaries of studies submitted to support the approval of the active substance;

• (c) information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet;

• (d) the trade name(s) of the substance;

• (e) the assessment report.

• (a) study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation; and

• (b) the assessment report.

Article 68

Record-keeping and reporting

SECTION 2 Information about biocidal products

Article 69

Classification, packaging and labelling of biocidal products

In addition, products which may be mistaken for food, including drink, or feed shall be packaged to minimise the likelihood of such a mistake being made. If they are available to the general public, they shall contain components to discourage their consumption and, in particular, shall not be attractive to children.

• (a) the identity of every active substance and its concentration in metric units;

• (b) the nanomaterials contained in the product, if any, and any specific related risks, and, following each reference to nanomaterials, the word ‘nano’ in brackets;

• (c) the authorisation number allocated to the biocidal product by the competent authority or the Commission;

• (d) the name and address of the authorisation holder;

• (e) the type of formulation;

• (f) the uses for which the biocidal product is authorised;

• (g) directions for use, frequency of application and dose rate, expressed in metric units, in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorisation;

• (h) particulars of likely direct or indirect adverse side effects and any directions for first aid;

• (i) if accompanied by a leaflet, the sentence ‘Read attached instructions before use’ and, where applicable, warnings for vulnerable groups;

• (j) directions for the safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on the reuse of packaging;

• (k) the formulation batch number or designation and the expiry date relevant to normal conditions of storage;

• (l) where applicable, the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by humans or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use and transport;

• (m) where applicable, the categories of users to which the biocidal product is restricted;

• (n) where applicable, information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water;

• (o) for biocidal products containing micro-organisms, labelling requirements in accordance with Directive 2000/54/EC.

By way of derogation from the first subparagraph, where this is necessary because of the size or the function of the biocidal product, the information referred to in points (e), (g), (h), (j), (k), (l) and (n) may be indicated on the packaging or on an accompanying leaflet integral to the packaging.

• (a) the provision of models or drafts of the packaging, labelling and leaflets;

• (b) that biocidal products made available on the market in their territories be labelled in their official language or languages.

Article 70

Safety data sheets

Safety data sheets for active substances and biocidal products shall be prepared and made available in accordance with Article 31 of Regulation (EC) No 1907/2006, where applicable.

Article 71

Register for Biocidal Products

Where the Agency decides that the application has not been submitted in the correct format, it shall reject the application and inform the applicant accordingly.

The information to be introduced into the Register for Biocidal Products shall include, as appropriate:

• (a) the terms and conditions of the authorisation;

• (b) the summary of the biocidal product characteristics referred to in Article 22(2);

• (c) the assessment report of the biocidal product.

The information referred to in this paragraph shall also be made available to the applicant through the Register for Biocidal Products.

Article 72

Advertising

Article 73

Poison control

Article 45 of Regulation (EC) No 1272/2008 shall apply for the purposes of this Regulation.

CHAPTER XVI THE AGENCY

Article 74

Role of the Agency

Article 75

Biocidal Products Committee

The Biocidal Products Committee shall be responsible for preparing the opinion of the Agency on the following issues:

• (a) applications for approval and renewal of approval of active substances;

• (b) review of approval of active substances;

• (c) applications for inclusion in Annex I of active substances meeting the conditions laid down in Article 28 and review of the inclusion of such active substances in Annex I;

• (d) identification of active substances which are candidates for substitution;

• (e) applications for Union authorisation of biocidal products and for renewal, cancellation and amendments of Union authorisations, except where the applications are for administrative changes;

• (f) scientific and technical matters concerning mutual recognition in accordance with Article 38;

• (g) at the request of the Commission or of Member States’ competent authorities, any other questions that arise from the operation of this Regulation relating to technical guidance or risks to human health, animal health or the environment.

In order to facilitate its work, the Committee may, by a decision of the Management Board of the Agency in agreement with the Commission, be divided into two or more parallel committees. Each parallel committee shall be responsible for the tasks of the Biocidal Products Committee assigned to it. Each Member State shall be entitled to appoint one Member for each of the parallel committees. The same person may be appointed to more than one parallel committee.

Article 76

Secretariat of the Agency

• (a) establishing and maintaining the Register for Biocidal Products;

• (b) performing the tasks relating to the acceptance of the applications covered by this Regulation;

• (c) establishing technical equivalence;

• (d) providing technical and scientific guidance and tools for the application of this Regulation by the Commission and Member States’ competent authorities and providing support to national helpdesks;

• (e) providing advice and assistance to applicants, in particular to SMEs, for the approval of an active substance or its inclusion in Annex I to this Regulation or for a Union authorisation;

• (f) preparing explanatory information on this Regulation;

• (g) establishing and maintaining database(s) with information on active substances and biocidal products;

• (h) at the request of the Commission, providing technical and scientific support to improve cooperation between the Union competent authorities, international organisations and third countries on scientific and technical issues relating to biocidal products;

• (i) notification of decisions taken by the Agency;

• (j) specification of formats and software packages for the submission of information to the Agency;

• (k) providing support and assistance to Member States in order to avoid the parallel assessment of applications relating to the same or similar biocidal products referred to in Article 29(4);

• (l) providing support and assistance to Member States with regard to control and enforcement activities.

Article 77

Appeal

Article 92 (1) and (2) and Articles 93 and 94 of Regulation (EC) No 1907/2006 shall apply to appeal procedures lodged under this Regulation.

Fees may be payable, in accordance with Article 80(1) of this Regulation, by the person bringing an appeal.

Article 78

The budget of the Agency

• (a) a subsidy from the Union, entered in the general budget of the European Union (Commission Section);

• (b) the fees paid to the Agency in accordance with this Regulation;

• (c) any charges paid to the Agency for services that it provides under this Regulation;

• (d) any voluntary contributions from Member States.

Revenues of the Agency as referred to in Article 96(1) of Regulation (EC) No 1907/2006 shall not be used for carrying out tasks under this Regulation, unless for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency. Revenues of the Agency as referred to in paragraph 1 of this Article shall not be used for carrying out tasks under Regulation (EC) No 1907/2006, unless for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency.

Article 79

Formats and software for submission of information to the Agency

The Agency shall specify formats and software packages and make them available free of charge on its website for submissions to the Agency. The competent authorities and applicants shall use these formats and packages in their submissions pursuant to this Regulation.

The technical dossier referred to in Article 6(1) and Article 20 shall be submitted using the IUCLID software package.

CHAPTER XVII FINAL PROVISIONS

Article 80

Fees and charges

• (a) the fees payable to the Agency, including an annual fee for products granted a Union authorisation in accordance with Chapter VIII and a fee for applications for mutual recognition in accordance with Chapter VII;

• (b) the rules defining conditions for reduced fees, fee waivers and the reimbursement of the member of the Biocidal Products Committee who acts as a rapporteur; and

• (c) conditions of payment.

That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3). It shall apply only with respect to fees paid to the Agency.

The Agency may collect charges for other services it provides.

The fees payable to the Agency shall be set at such a level as to ensure that the revenue derived from the fees, when combined with other sources of the Agency’s revenue pursuant to this Regulation, is sufficient to cover the cost of the services delivered. The fees payable shall be published by the Agency.

Based on the principles set out in paragraph 3, the Commission shall issue guidance concerning a harmonised structure of fees.

Member States may levy annual fees with respect to biocidal products made available on their markets.

Member States may collect charges for other services they provide.

Member States shall set and publish the amount of fees payable to their competent authorities.

• (a) fees shall be set at such a level as to ensure that the revenue derived from the fees is, in principle, sufficient to cover the cost of the services delivered and shall not exceed what is necessary to cover those costs;

• (b) partial reimbursement of the fee if the applicant fails to submit the information requested within the specified time limit;

• (c) the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases;

• (d) the structure and amount of fees shall take into account whether information has been submitted jointly or separately;

• (e) in duly justified circumstances, and where it is accepted by the Agency or the competent authority, the whole fee or a part of it may be waived; and

• (f) the deadlines for the payment of fees shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation.

Article 81

Competent authorities

Member States shall ensure that competent authorities have a sufficient number of suitably qualified and experienced staff so that the obligations laid down in this Regulation can be carried out efficiently and effectively.

Competent authorities may in particular provide advice by establishing helpdesks. Helpdesks already established under Regulation (EC) No 1907/2006 may act as helpdesks under this Regulation.

The Commission shall make publicly available a list of competent authorities and helpdesks.

Article 82

Committee procedure

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

Article 83

Exercise of the delegation

Article 84

Urgency procedure

Article 85

Adaptation to scientific and technical progress

In order to allow the provisions of this Regulation to be adapted to scientific and technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the adaptation of Annexes II, III and IV to such scientific and technical progress.

Article 86

Active substances included in Annex I to Directive 98/8/EC

Active substances for which the Commission has adopted directives including them in Annex I to Directive 98/8/EC shall be deemed to have been approved under this Regulation on the date of inclusion and shall be included in the list referred to in Article 9(2). Approval shall be subject to the conditions set out in those Commission directives.

Article 87

Penalties

Member States shall lay down the provisions on penalties applicable to infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission no later than 1 September 2013 and shall notify the Commission without delay of any subsequent amendment affecting them.

Article 88

Safeguard clause

Where, on the basis of new evidence, a Member State has justifiable grounds to consider that a biocidal product, although authorised in accordance with this Regulation, constitutes a serious immediate or long-term risk to the health of humans, particularly of vulnerable groups, or animals, or to the environment, it may take appropriate provisional measures. The Member State shall, without delay, inform the Commission and the other Member States accordingly and give reasons for its decision based on the new evidence.

The Commission shall, by means of implementing acts, either permit the provisional measure for a time period defined in the decision or require the Member State to revoke the provisional measure. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).

Article 89

Transitional measures

Depending upon the progress of the work programme, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the extension of the duration of the work programme for a determined period.

In order to facilitate a smooth transition from Directive 98/8/EC to this Regulation, during the work programme the Commission shall adopt either implementing regulations providing that an active substance is approved, and under which conditions, or, in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, implementing decisions stating that an active substance is not approved. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3). Regulations approving an active substance shall specify the date of approval. Article 9(2) shall apply.

• (a) existing active substances which:
• (i) have been evaluated under Commission Regulation (EC) No 1451/2007 ([^E0038]), but which have not yet been approved for that product-type; or
• (ii) are being evaluated, under Regulation (EC) No 1451/2007, but which have not yet been approved for that product-type; or

• (b) a combination of active substances referred to in point (a) and active substances approved in accordance with this Regulation. By way of derogation from the first subparagraph, in the case of a decision not to approve an active substance, a Member State may continue to apply its current system or practice of making biocidal products available on the market for up to 12 months after the date of the decision not to approve an active substance in accordance with the third subparagraph of paragraph 1, and may continue to apply its current system or practice of using biocidal products for up to 18 months after that decision.

To that effect, those wishing to apply for the authorisation or mutual recognition in parallel of biocidal products of that product-type containing no active substances other than existing active substances shall submit applications for authorisation or mutual recognition in parallel no later than the date of approval of the active substance(s). In the case of biocidal products containing more than one active substance, applications shall be submitted no later than the date of approval of the last active substance for that product-type.

Where no application for authorisation or mutual recognition in parallel has been submitted in accordance with the second subparagraph:

• (a) the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance(s); and

• (b) use of existing stocks of the biocidal product may continue for up to 365 days after the date of approval of the active substance(s).

• (a) a biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market with effect from 180 days after the date of the decision of the authority; and

• (b) use of existing stocks of the biocidal product may continue for up to 365 days after the date of the decision of the authority.

Article 90

Transitional measures concerning active substances evaluated under Directive 98/8/EC

That evaluation shall be carried out on the basis of the information provided in the dossier submitted under Directive 98/8/EC.

Where the evaluation identifies concerns arising from the application of provisions of this Regulation which were not included in Directive 98/8/EC, the applicant shall be given the opportunity to provide additional information.

Every effort shall be made to avoid additional testing on vertebrates and to avoid causing delays to the review programme laid down in Regulation (EC) No 1451/2007 as a result of these transitional arrangements.

Notwithstanding paragraph 1, the Agency shall also be responsible for coordinating the evaluation process of dossiers submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by 1 September 2013 and shall facilitate the preparation of the evaluation by providing organisational and technical support to the Member States and the Commission from 1 January 2014.

Article 91

Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC

Applications for biocidal product authorisations submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by 1 September 2013 shall be evaluated by the competent authorities in accordance with that Directive.

Notwithstanding the first paragraph, the following shall apply:

• — where the risk assessment of the active substance indicates that one or more of the criteria listed under Article 5(1) is met, the biocidal product shall be authorised in accordance with Article 19,

• — where the risk assessment of the active substance indicates that one or more of the criteria listed under Article 10 is met, the biocidal product shall be authorised in accordance with Article 23.

Where the evaluation identifies concerns arising from the application of provisions of this Regulation which were not included in Directive 98/8/EC, the applicant shall be given the opportunity to provide additional information.

Article 92

Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC

Biocidal products authorised in accordance with Article 3 or 4 of Directive 98/8/EC shall be considered as authorised in accordance with Article 17 of this Regulation.

Article 93

Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC

By way of derogation from Article 17(1), a Member State may continue to apply its current system or practice of making available on the market and using a biocidal product not covered by the scope of Directive 98/8/EC, but falling within the scope of this Regulation, and consisting of, containing or generating only active substances that were available on the market, or used in biocidal products, on 1 September 2013. The derogation shall apply until one of the following dates:

• (a) where applications for approval of all those active substances, which the biocidal product consists of, contains or generates, are submitted for the relevant product-type by 1 September 2016, the deadlines provided for in the second subparagraph of Article 89(2), in Article 89(3) and in Article 89(4); or

• (b) where an application is not submitted in accordance with point (a) for one of the active substances, until 1 September 2017.

Article 94

Transitional measures concerning treated articles

• (a) in the case of a decision adopted after 1 September 2016 to reject the application for approval of, or not to approve, one of the active substances for the relevant use, the date falling 180 days after such a decision;

• (b) in other cases, the date of approval for the relevant product-type and use of the last active substance to be approved and contained in the biocidal product.

Article 95

Transitional measures concerning access to the active substance dossier

A person established within the Union who manufactures or imports a relevant substance, on its own or in biocidal products (‘the substance supplier’) or who manufactures or makes available on the market a biocidal product consisting of, containing or generating that relevant substance (‘the product supplier’), may at any time submit to the Agency either a complete substance dossier for that relevant substance, a letter of access to a complete substance dossier, or a reference to a complete substance dossier for which all data protection periods have expired. Following the renewal of the approval of an active substance, any substance supplier or product supplier may submit to the Agency a letter of access to all the data which was considered by the evaluating competent authority as relevant for the purpose of the renewal, and for which the protection period has not yet expired (‘the relevant data’).

The Agency shall inform the submitting supplier of the fees payable under Article 80(1). It shall reject the application if the submitting supplier fails to pay those fees within 30 days and shall inform the submitting supplier accordingly.

Upon receipt of the fees payable under Article 80(1), the Agency shall verify whether the submission complies with the second subparagraph of this paragraph and shall inform the submitting supplier accordingly.

By way of derogation from the first subparagraph of this paragraph, all data protection periods for active substance/product-type combinations for which a decision on the approval has not been adopted in accordance with Article 89(1), third subparagraph, by 7 June 2018, shall end on 31 December 2030.

Data owners may claim compensation for access to their data for the period from 1 January 2026 to 15 June 2026 from a substance supplier or product supplier having benefitted from the absence of protection and having been included in the list referred to in paragraph 1 of this Article during that period.

Article 96

Repeal

Without prejudice to Articles 86, 89 to 93 and 95 of this Regulation, Directive 98/8/EC is hereby repealed with effect from 1 September 2013.

References to the repealed Directive shall be construed as references to this Regulation and read in accordance with the correlation table in Annex VII.

Article 97

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 September 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

LIST OF ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 25(a)

EC number	Name/group	Restriction	Comment
Category 1 —  Substances authorised as food additives according to Regulation (EC) No 1333/2008	Category 1 —  Substances authorised as food additives according to Regulation (EC) No 1333/2008	Category 1 —  Substances authorised as food additives according to Regulation (EC) No 1333/2008	Category 1 —  Substances authorised as food additives according to Regulation (EC) No 1333/2008
200-018-0	Lactic acid	Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008	E 270
204-823-8	Sodium acetate	Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008	E 262
208-534-8	Sodium benzoate	Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008	E 211
201-766-0	(+)-Tartaric acid	Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008	E 334
200-580-7	Acetic acid	Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008	E 260
201-176-3	Propionic acid	Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008	E 280
Category 2 —  Substances included in Annex IV to Regulation (EC) No 1907/2006	Category 2 —  Substances included in Annex IV to Regulation (EC) No 1907/2006	Category 2 —  Substances included in Annex IV to Regulation (EC) No 1907/2006	Category 2 —  Substances included in Annex IV to Regulation (EC) No 1907/2006
200-066-2	Ascorbic acid
232-278-6	Linseed oil
—	Nitrogen generated from ambient air	Applications for product authorisations shall include evidence that exposure of the user and the general public to a hypoxic atmosphere is avoided and, where appropriate, the necessary measures are taken.	—
Category 3 —  Weak acids	Category 3 —  Weak acids	Category 3 —  Weak acids	Category 3 —  Weak acids
Category 4 —  Traditionally used substances of natural origin	Category 4 —  Traditionally used substances of natural origin	Category 4 —  Traditionally used substances of natural origin	Category 4 —  Traditionally used substances of natural origin
Natural oil	Lavender oil		CAS 8000-28-0
Natural oil	Peppermint oil		CAS 8006-90-4
Not available	Vinegar [^E0039]	Excluding vinegar that is not food and excluding vinegar that contains more than 10 % acetic acid (whether or not it is food).	CAS No 8028-52-2
Not available	Saccharomyces cerevisiae (yeast) [^E0040]	Excluding Saccharomyces cerevisiae that is not food or feed.	CAS No 68876-77-7
Not available	Powdered egg [^E0041]	Excluding powdered egg that is not food or feed.
Not available	Honey [^E0042]	Excluding honey that is not food or feed.	CAS No 8028-66-8
200-333-3	D-Fructose [^E0043]	Excluding D-fructose that is not food or feed.	CAS No 57-48-7
Not available	Cheese [^E0044]	Excluding cheese that is not food or feed.
Not available	Concentrated apple juice [^E0045]	Excluding concentrated apple juice that does not fall within the definition in point (2) of Part I of Annex I to Council Directive 2001/112/EC [^E0046].
Category 5 —  Pheromones	Category 5 —  Pheromones	Category 5 —  Pheromones	Category 5 —  Pheromones
222-226-0	Oct-1-en-3-ol
Mixture	Webbing clothes moths pheromone
Category 6 —  Substances for which a Member State has validated an active substance dossier in accordance with Article 7(3) of this Regulation or accepted such a dossier in accordance with Article 11(1) of Directive 98/8/EC	Category 6 —  Substances for which a Member State has validated an active substance dossier in accordance with Article 7(3) of this Regulation or accepted such a dossier in accordance with Article 11(1) of Directive 98/8/EC	Category 6 —  Substances for which a Member State has validated an active substance dossier in accordance with Article 7(3) of this Regulation or accepted such a dossier in accordance with Article 11(1) of Directive 98/8/EC	Category 6 —  Substances for which a Member State has validated an active substance dossier in accordance with Article 7(3) of this Regulation or accepted such a dossier in accordance with Article 11(1) of Directive 98/8/EC
204-696-9	Carbon dioxide	The authorisation of biocidal products containing carbon dioxide as an active substance shall be subject to the following conditions: (a) the exposure of professional users to carbon dioxide remains below the acceptable exposure concentration (AEC) of: (i) 1,5 % volume/volume (v/v) carbon dioxide for the short-term exposure limit (STEL) of 15 minutes; and (ii) 0,5 % v/v carbon dioxide for the time-weighted average (TWA) of 8 hours; (b) the exposure of general public users or by-standers to carbon dioxide remains below 0,1 % v/v carbon dioxide; (c) where appropriate, the necessary measures shall be taken by the user as described in the summary of product characteristics.	—
204-696-9	Carbon dioxide generated from propane, butane or a mixture of both by combustion [^E0048]		CAS No 124-38-9
201-069-1	Citric acid	Minimum degree of purity of the active substance [^E0047]: 995 g/kg	CAS No 77-92-9
231-783-9	Nitrogen	Only for use in limited quantities in ready-for-use canisters
246-376-1	Potassium (E,E)-hexa-2,4-dienoate (potassium sorbate) [^E0049]	Minimum degree of purity of the active substance [^E0050]: 990 g/kg	CAS No 24634-61-5
Not available	(9Z,12E)-tetradeca-9,12-dien-1-yl acetate		CAS 30507-70-1
Category 7 —  Other	Category 7 —  Other	Category 7 —  Other	Category 7 —  Other
	Baculovirus
215-108-5	Bentonite
203-376-6	Citronellal
231-753-5	Iron sulphate

The date of approval of vinegar for product-type 19 for the purposes of Article 89(3) is 1 June 2021.

The date of approval of Saccharomyces cerevisiae for product-type 19 for the purposes of Article 89(3) is 1 June 2021.

The date of approval of powdered egg for product-type 19 for the purposes of Article 89(3) is 1 June 2021.

The date of approval of honey for product-type 19 for the purposes of Article 89(3) is 1 June 2021.

The date of approval of D-fructose for product-type 19 for the purposes of Article 89(3) is 1 June 2021.

The date of approval of cheese for product-type 19 for the purposes of Article 89(3) is 1 June 2021.

The date of approval of concentrated apple juice for product-type 19 for the purposes of Article 89(3) is 1 June 2021.

Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (OJ L 10, 12.1.2002, p. 58).

The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated activesubstance.

The date of approval of carbon dioxide generated from propane, butane or a mixture of both by combustion for product-type 19 for the purposes of Article 89(3) is 1 July 2022.

The date of approval of potassium sorbate for product-type 6 for the purposes of Article 89(3) is 1 February 2023.

The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

ANNEX II

INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES

• 1.This Annex sets out the information requirements for the preparation of the dossier referred to in point (a) of Article 6(1).

• 2.The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS). The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all active substances. However, in some cases the physical or chemical properties of the substance may mean that it is impossible or unnecessary to provide specific data elements belonging to the CDS.

• With regard to the ADS, the data elements to be provided for a specific active substance shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the substance, existing data, information which is part of the CDS and the types of products in which the active substance will be used and the exposure patterns related to these uses.

• Specific indications for the inclusion of some data elements are provided in column 1 of the Annex II table. The general considerations regarding adaptation of information requirements as set out in Annex IV shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the Annex II table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates. The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria referred to in Article 4(1) are met.

• The applicant should consult the detailed technical guidance regarding the application of this Annex and the preparation of the dossier referred to in point (a) of Article 6(1), which is available on the website of the Agency.

• The applicant shall initiate a pre-submission consultation with the prospective evaluating body. In addition to the obligation set out in Article 62(2), applicant may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out. The applicant shall document such pre-submission consultations and their outcomes and shall include the relevant documents in the application.

• Additional information may need to be submitted if it is necessary to carry out the evaluation as indicated in Article 8(2).

• 3.A detailed and full description of the studies conducted or referred to and of the methods used shall be included. It is important to ensure that the data available is relevant and is of sufficient quality to fulfil the requirements. Evidence should also be provided to demonstrate that the active substance upon which the tests have been carried out is the same as the substance for which the application has been submitted.

• 4.The formats made available by the Agency must be used for submission of the dossiers. In addition, IUCLID must be used for those parts of the dossiers to which IUCLID applies. Formats and further guidance on data requirements and dossier preparation are available on the website of the Agency.

• 5.Tests submitted for the purpose of the approval of an active substance shall be conducted in accordance with the methods described in Commission Regulation (EC) No 440/2008 ([^E0051]), or any revised version of these methods not yet included in that Regulation.

• However, if a method is inappropriate or not described in Commission Regulation (EC) No 440/2008, other methods shall be used which are scientifically appropriate and their appropriateness shall be justified in the application.

• When test methods are applied to nano-materials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and where applicable, of the technical adaptations or adjustments that have been made in order to respond to the specific characteristics of these materials.

• 6.Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes ([^E0052]) and in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances ([^E0053]) or other international standards recognised as being equivalent by the Commission or the Agency. Tests on physico-chemical properties and safety-relevant substance data should be performed at least according to international standards.

• 7.Where testing is done, a detailed description (specification) of the active substance used and its impurities must be provided. Testing should be performed with the active substance as manufactured or, in the case of some of the physical and chemical properties (see indications given in column I of the table), with a purified form of the active substance.

• 8.Where test data exist that have been generated before 1 September 2013 by methods other than those laid down in Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct new tests according to the Regulation (EC) No 440/2008 must be decided by the competent authority of the Member State concerned, on a case-by-case basis, taking into account, among other factors, the need to minimise testing on vertebrates.

• 9.New tests involving vertebrates shall be conducted as the last available option to comply with the data requirements set out in this Annex when all the other data sources have been exhausted. In-vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall also be avoided.

TITLE 1

CHEMICAL SUBSTANCES

Core data set and additional data set for active substances

Information required to support the approval of an active substance is listed in the table below.

Conditions for not requiring a specific test that are set out in the appropriate test methods in the Regulation (EC) No 440/2008 and are not repeated in column 3, also apply.