Rs 813.121 Order Of The Dfi On 15 August 2014 On The Implementation Rules On The Ordinance On Biocidal Products (Enforcement Order Of The Dfi On Biocides)

Original Language Title: RS 813.121 Ordonnance du DFI du 15 août 2014 sur les règles d’exécution relatives à l’ordonnance sur les produits biocides (Ordonnance d’exécution du DFI sur les produits biocides)

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813.121 order of the DFI on rules of execution the Ordinance on biocidal products (enforcement order of the DFI on biocides) of August 15, 2014 (State on September 15, 2015) the federal Department of Home Affairs (FDHA), in agreement with the federal Department of the environment, transport, energy and communications (DETEC) and the federal Department of the economy training and research (DAVIS), view the art. 15, al. 2: 24, al. 3, and 26, al. 10, of the Ordinance of 18 May 2005 on biocides (OBP), stop: Section 1 object, scope and definitions article 1 purpose this order regulates the procedure applicable to the body of notification of chemicals (ON), to holders of permissions and importers of biocidal products and biocidal products families: a. for the authorization of a same product within the meaning of art. 15 OBP, taking account of the implementing Regulation (EU) n 414/2013; (b) for the modification of an authorization within the meaning of art. 24 OBP and for changes of biocidal products not subject to authorization to the senses of the art. 13 c and 13d OBP, taking into account the regulations (EU) n 354/2013; c. for the extension of the recognition in the sense of art. 26, al. 10, OBP, taking into account the delegated Regulation (EU) n 492/2014.

Implementing regulations and delegated to the EU regulations are not taken into account for the YEAR or AC authorisation procedures.

New content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).
Implementing Regulation (EU) n 414/2013 the Commission of 6 may 2013, specifying the procedure for approval the same biocidal product in accordance with European regulation (EU) No. 528/2012 of the Parliament and the Council, OJ L 125 of the 7.5.2013 version, p. 4.
Implementing Regulation (EU) n 354/2013 the Commission on April 18, 2013 relative to changes in authorised biocidal products in accordance with the R (EU) n 528/2012 to the European Parliament and of the Council, OJ L 109 of the 19.4.2013 version, p. 4.
Introduced by chapter I of O of the DFI on August 31, 2015, in force since 15, seven. 2015 (2015 3073 RO).
Delegated Regulation (EU) n 492/2014 the Commission March 7, 2014, supplementing the Regulation (EU) No. 528/2012 of the Parliament and the Council regarding the terms of renewal of authorities for biocidal products subject to mutual recognition, version of the OJ L 139 of the 14.5.2014, p. 1.
New content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).

Art. 2 exclusion from the scope of this order does not apply to permissions for exceptional situations.

Art. 3 definitions insofar as nothing else is not apparent from any provision of this order, we hear, in this order: a. by permission: all types of authorization referred to in art. 7, al. 1: OBP; b. by recognition: the two types of authorization referred to in art. 7, al. 1, let. g and h, OBP.

When referred to in this order, in this paragraph means authorisation: a. AL permission; b. approval AnL; c. the simplified authorization; (d) the authorisation of a biocidal product the same, as long as it is not identical to a biocidal product for the benefit of a leave YEAR or AC.

Section 2 procedures for authorization of a same product art. 4 same biocidal product a same product within the meaning of art. 15 OBP is a biocidal product: a. which is identical to a reference product, i.e.: 1. to a biocidal product authorized or recognized, or to a product of a family of biocidal products authorised or recognised, or 2. a biocidal product or a product of a family of biocides for which a corresponding request is pending with you; or (b) that there is a divergence of an administrative nature (art. 11, para. 1) compared to a reference product.

New content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).
New content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).

Art. 5 request a request for authorisation for a biocidal product must include the following information: a. the authorisation of the reference product number or, if the request is still pending, the Chemical Product Identification (CPID) that is assigned to the request upon confirmation of receipt; b. the indication of the differences between the same biocidal product and the reference product requested in respect of administrative art changes. 11, al. 1, as well as evidence that the two products are identical in all other respects; c. a letter of access to the data on which is based the authorisation of the reference product, insofar as is required under art. 27, al. 1, let. a, OBP; (d) a draft summary of the characteristics of the same product (SPC) within the meaning of art. 20, al. 2, let. b, OBP.

To YEAR and AC permissions, simply to pass on information about the identity of the product and contact, addresses the label as well as the technical project if it exists. In addition, for products used for professional or commercial, the safety data sheet must be sent insofar as it must be established under art. 52 of the Ordinance of 18 May 2005 on chemicals. For this purpose, it provides a form on its website.

New content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).
Replaces the old CPID registration number.
New content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).
New content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).
Summary of Products Characteristics SR 813.11 www.bag.admin.ch/anmeldestelle/index.html?lang=fr art. 6 advance on fees, validation and evaluation we confirm the receipt of the request and ordered the applicant to pay an advance on costs in respect of the emoluments referred to in annex, ch. II, point 1.7 of the Ordinance of 18 May 2005 on fees related to chemicals (OEChim) within a period of 30 days after confirmation of receipt of demand.
If the advance on costs is not paid within the time limit, it is not material on demand. It shall forward it to the applicant.
In the contrary case, it confirms that the advance on costs has been received within the time limit and validates the request within 30 days.
The validation includes: a. check that all information requested in art. 5 are met; (b) verification that the differences offered by the applicant between the same biocidal product and the reference product are only differences that can be the subject of an administrative change in accordance with art. 11, al. 1. one forwards the request to the review bodies and ensure that they evaluate it within a period of 60 days following the validation. When the application is on the same biocidal product and that the authorisation of the reference product decision is still pending from one, the period begins to run from the date of the authorisation of the reference product.
Summary procedure apply to validation and evaluation for a leave YEAR or AC.

RS 813.153.1 new content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).
New content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).

Art. 7Contenu of the decision the same biocidal product receives another authorization number as that of the reference product.
The content of the authorisation of a biocidal product and the content of the authorisation of the reference product are the same. Are reserved differences proposed under art. 5, al. 1, let. b, and which have been taken into account by one for the same biocidal product authorisation.
The authorisation of a biocidal product and approval to a reference product may be modified or revoked regardless of the other.

New content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).

Section 3 authorisation of a biocidal Art. product change Procedure 8 classification of changes and monitoring we class the change requested by the holder of the authorisation in one of the categories set out in art. 24, al. 2, OBP.
It takes into account the criteria referred to in the annex to the implementing Regulation (EU) n 354/2013.
He may at any time ask the holder of an authorization to provide all of the information related to the implementation of a given change.
Summary procedure apply to changes for a leave YEAR or AC.

CF. footnote page about art. 1, al. 1, let. b. art. 9 grouping of changes if the holder of an authorization intends to make several changes to the authorization, it presents for each of them a notification or a separate application.
As an exception to the al. 1, it is possible: a. to submit a single notification for several administrative changes if the latter:

1 concern in the same way of the different biocides, or2. concern the same biocidal product;

(b) to present a single application for several changes to the same biocidal product if one of the following conditions is met: 1 only one of the proposed amendments corresponds to a change, whether major or minor, the authorisation of the biocidal product, and all other amendments grouped directly therefrom, 2 modifications grouped stem directly from a new classification : - of one or more active substances in the biocidal product, - no active substances, or - the product itself, 3 modifications grouped stem directly from a specific condition of the authorization.

Art. 10 content of the notification or the request notifications or requests presented by the holder of an authorization within the meaning of art. 9 must include: a. the application form; This includes: 1. a list of all authorities affected by the proposed changes, 2 as appropriate, the revised SPC project, in an official language of the Confederation; the SPC can be written only in English in the case of an authorization based on recognition;

(b) a description of all the requested changes; c. a description of the link between changes, when a change is the cause or the consequence of other changes to the terms of the same authorization; (d) all relevant supporting documents to demonstrate that the proposed amendment has no negative impact compared to previous findings with respect to compliance with the conditions set out in Chapter 2 sections 2A, 2B and 3, OBP.

New content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).
The form is based on the register of the European Chemicals Agency biocidal products. It is published by it to the following address: www.bag.admin.ch/anmeldestelle/index.html?lang=fr.

Art. 11 notification of administrative changes the holder of an authorization within the meaning of art. 3, al. 2, notifies to you administrative permission changes, taking into account the requirements of art. 10, as follows: a. for the amendments referred to in the annex, title 1, section 1, of the implementing Regulation (EU) n 354/2013: prior to their implementation; b. to the amendments referred to in the annex, title 1, section 2, point 1 to 10, of the implementing Regulation (EU) n 354/2013: within a period of 12 months from their implementation.

It confirms the receipt of the notification and ordered the applicant to pay an advance on costs in respect of the emoluments referred to in the annex, ch. II, ch. 6.1.1 OEChim within a period of 30 days after the confirmation of the receipt of the notification.
If the advance on costs is not paid within the time limit, it is not material on the notification. It shall forward it to the author.
Otherwise, confirmation that the advance on costs has been received within the time limit.
If one does not send communications to the notifier within a period of 30 days from the date of the confirmation referred to in para. 4, notified changes are deemed accepted. We shall decide on the change.
If he refuses the change notified, it informs the author of the notification within a period of 30 days stating the reasons for the refusal.

CF. footnote page about art. 1, al. 1, let. (b) RS 813.153.1 art. 12 request for minor modifications of authorisation the holder of an authorization within the meaning of art. 3, al. 2, shall submit to you a request for minor changes according to the annex, title 2, of the implementing Regulation (EU) n 354/2013.
It confirms the receipt of the request and ordered the applicant to pay an advance on costs in respect of the emoluments referred to in the annex, ch. II, ch. 6.1.2 OEChim within a period of 30 days after confirmation of receipt of demand.
If the advance on costs is not paid within the time limit, it is not material on demand. It shall forward it to the author.
Otherwise, confirmation to the applicant that the advance on costs has been received within the time limit and the request is accepted. If the requirements referred to in art. 10 are met, it validates the request within a period of 30 days.
It appears from the validation that a request is incomplete, asked its author to complete it within a period of 45 days, otherwise it rejects the request. Are reserved to exceptional circumstances justifying an extension of the deadline.
Once validation is complete, it forwards the request to the review bodies and ensures that they assess it within a period of 90 days.
It gives the author of the application within 45 days if it appears that additional information is needed to assess. Are reserved to exceptional circumstances justifying an extension of the deadline.
The period referred to in para. 6 is suspended until the missing information.
Considering not allowing the change, it entitles the applicant to be heard.
A decision to change approval or rejection of the application.

CF. footnote page about art. 1, al. 1, let. (b) RS 813.153.1 new content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).

Art. 13 request for minor changes of recognition recognition holder submits to one request which must be submitted to the Member State of the EU or European free trade (EFTA) Association or the European Agency (ECHA) chemicals in accordance with art. 50, per. 2, of Regulation (EU) No 528 / 2012 and the corresponding implementing provisions of the EU.
It confirms the receipt of the request and ordered the applicant to pay an advance on costs in respect of the emoluments referred to in the annex, ch. II, ch. 6.1.2 OEChim within a period of 30 days after confirmation of receipt of demand.
After receiving the assessment report and the revised summary of the characteristics of the biocidal product or, in the case of a Union, the position taken by ECHA authorisation, the applicant shall send these documents to you.
If the advance on costs is not paid within the time limit, it is not material on demand. He communicates it to the holder of the recognition.
Otherwise, as soon as it has received the documents referred to in para. 3, confirmation to the applicant that the advance on costs has been received within the time limit and the request is accepted.
After that the competent authority in the EU made its decision, the applicant shall forward to you: a. the agreed modification referred to in art. 7, by. 7 of the regulations (EU) n 354/2013; forgotten the source. in the case of an authorization of the Union, the summary revised features of the product in accordance with art. 12, by. 6, of the implementing Regulation (EU) n 354/2013.

One makes a decision to change the recognition or recognition of an authorisation of the Union in accordance with the decision of the competent authority in the EU. Reserved changes under art. 12, al. 2, OBP.

Regulation (EU) No. 528/2012 of the European Parliament and the Council of May 22, 2012, about the availability on the market and the use of biocides, OJ L 167 of the 27.6.2012, p. 1, amended lastly by Regulation (EU) n 334/2014, JO L 103 of the 5.4.2014, p. 22.
RS 813.153.1 Cf. footnote page about art. 1, al. 1, let. b. art. 14 application of major changes of authorisation the holder of an authorization within the meaning of art. 3, al. 2, submits to be a demand for major changes referred to in the annex, title 3, of the implementing Regulation (EU) n 354/2013.
It confirms the receipt of the request and ordered the applicant to pay an advance on costs in respect of the emoluments referred to in the annex, ch. II, ch. 6.1.3 OEChim within a period of 30 days after confirmation of receipt of demand.
If the advance on costs is not paid within the time limit, it is not material on demand. It shall forward it to the author.
Otherwise, confirmation to the applicant that the advance on costs has been received within the time limit and the request is accepted. If the requirements referred to in art. 10 are met, it validates the request within a period of 30 days.
If it appears that a request is incomplete, asked its author to complete it within a period of 90 days, otherwise it rejects the request. Are reserved to exceptional circumstances justifying an extension of the deadline.
Once validation is complete, it forwards the request to the review bodies and ensures that they assess it within a period of 180 days.
It gives the author of the application within 90 days if it appears that additional information is needed to assess. Are reserved to exceptional circumstances justifying an extension of the deadline.
The period referred to in para. 6 is suspended until the missing information.
Considering not allowing the change, it entitles the applicant to be heard.
A decision to change approval or rejection of the application.

CF. footnote page about art. 1, al. 1, let. b.

RS 813.153.1 new content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).

Art. 15 request for major modifications of recognition recognition holder submits to one request which must be submitted to the EU or EFTA Member State or ECHA in accordance with art. 50, per. 2, of Regulation (EU) No. 528/2012 and the corresponding implementing provisions of the EU.
It confirms the receipt of the request and ordered the applicant to pay an advance on costs in respect of the emoluments referred to in the annex, ch. II, ch. 6.1.3 OEChim within a period of 30 days after confirmation of receipt of demand.
After receiving the assessment report and the revised summary of the characteristics of the biocidal product or, in the case of a Union, the position taken by ECHA authorisation, the applicant shall send these documents to you.
If the advance on costs is not paid within the time limit, it is not material on demand. It shall forward it to the author.
Otherwise, as soon as it has received the documents referred to in para. 3, confirmation to the applicant that the advance on costs has been received within the time limit and the request is accepted.
After that the competent authority in the EU made its decision, the applicant shall forward to you: a. the agreed modification referred to in art. 8, by. 7 of the regulations (EU) n 354/2013; forgotten the source. in the case of an authorization of the Union, the summary revised features of the product in accordance with art. 13, by. 8 and 16 of the implementing Regulation (EU) n 354/2013.

One makes a decision of change of recognition in accordance with the decision of the competent authority in the EU. Reserved changes under art. 12, al. 2, OBP.

CF. footnote page about art 13, al. 1 RS 813.153.1 Cf. footnote page about art. 1, al. 1, let. b. art. 15aLiquidation of stocks when a modification of an authorization is accepted, biocidal products that may be placed on the market under the previous authorization may, from the acceptance of the change: a. be placed on the market for 180 days; b. be provided to end users and used professional or commercial capacity for 180 days.

Introduced by chapter I of O of the DFI on August 31, 2015, in force since 15, seven. 2015 (2015 3073 RO).

Section 3aprocedure for the extension of recognition art. 15b general recognition within the meaning of art. 7, al. 1, let. g, OBP can be extended in accordance with the provisions of this section when their conditions or their charges are, at the time of the request, identical to those imposed by authorities and, as appropriate, by the recognition in the Member States of the EU or EFTA for which a request for extension is also filed.
As an exception to the al. 1, a request for extension of recognition can also be filed when the conditions or costs imposed by authorities and, as appropriate, by the recognition in the EU or EFTA Member States are differing on one or more aspects to the title of the following changes: a. administrative changes within the meaning of title I of the annex to Regulation (EU) n 354/2013; b. changes within the meaning of art. 1, by. 3, points b to d, delegated Regulation (EU) No 492/2014, as long as they have been accepted by the applicant and that they comply with the provisions of directive 98/8/EC referred in the above provision.

CF. footnote page about art. 1, al. 1, let. (b) see footnote page about art. 1, al. 1, let. c. Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 on the placing on the market of biocides, OJ L 123 of the 24.4.1998, p. 1. amended lastly by directive 2013/44/EU, OJ L 204 of the 31.7.2013, p. 49.

Art. 15 c content of request the request for extension of recognition must be submitted using the form provided for this purpose and in the format prescribed in art. 14, al. 4, let. a, OBP.
It must include the following: a. the name of the Member State of the EU or EFTA, which has granted approval and evaluated the request, if necessary the name of the Member State of the EU or EFTA, chosen by the applicant as well as the confirmation that said State agrees to be responsible for the assessment of the application (reference state); b. a list of members of the EU and other States in which EFTA States approval or recognition should be extended and the numbers of granted permissions; c. confirmation of the applicant that these permissions to meet the requirements of art. 15b; d. the SPC project, in an official language of the Confederation or in English; e. If you ask them: 1. all the data required in art. 26, al. 3, let. a, OBP, 2. the assessment of the applicant as to the question of whether the conclusions of the assessment of the biocidal product are still valid, as well as a review critical of all of the information provided under art. 21 OBP, including items for this assessment.

The data required for the al. 2, let. e, ch. 1, must include the following: a. the task list before be performed by the holder of the authorization according to the charges or terms of authorization in the Member States of the EU or the EFTA States and the confirmation that these tasks have been completed; (b) the list of decisions regarding the changes agreed by any Member State EU or by another State of EFTA prior to September 1, 2013; c. the list of decisions regarding the changes agreed by any Member State of the EU or an another EFTA State in accordance with the regulations (EU) n 354/2013; d. list notifications or change requests submitted to any Member State of the EU or an another EFTA State in accordance with the regulations (EU) n 354/2013 which are pending at the date of submission of the request for extension.

CF. footnote page about art. 1, al. 1, let. b. art. 15 d advance on costs and check the application for extension of recognition must be filed with it along with the request for extension of the authorisation filed in the State of reference.
It confirms the receipt of the request and ordered the applicant to pay an advance on costs in respect of the emoluments referred to in the annex, ch. II, ch. 5.3, OEChim within a period of 30 days after the confirmation of the receipt of the request.
If the advance on costs is not paid within the time limit, it is not material on demand. It shall forward it to the applicant.
Otherwise, confirmation to the applicant that the advance on costs has been received within the time limit and that the request has been accepted, indicating the acceptance date.
Verified within a period of 30 days that the requirements of art. 15b are met.
If the requirements of art. 15b are not met, it shall inform the applicant within 30 days of acceptance of the application and addresses, unless otherwise directed by the applicant, as a request for extension of a permit within the meaning of art. 26 OBP.

SR 813.153.1 art. 15th Decision the applicant transmits to you the assessment report prepared by the reference state as part of the extension of the authorisation procedure and the draft SPC as soon as it receives them.
The time allotted to him to take a position on the assessment report and, where appropriate, on the project of CPS communicating to the applicant.
When voting on the extension of a recognition, based on the procedure under art. the delegated Regulation (EU) n 492/2014 5.
It takes its decision within a period of 120 days, according to the rules laid down in art. 53, al. 1, let. a and b, OBP.
The duration of the extension is the art. 8, al. 1, let. e, OBP.
When the time limit provided in para. 4 cannot be met and that the applicant is not responsible, we extend the existing recognition for the time necessary.

CF. footnote page about art. 1, al. 1 let.c.

Art. 15F inventories when the extension of recognition is refused, the biocidal products have attained the refusal of the extension: a. be placed on the market for 180 days; b. be provided to end users and used professional or commercial capacity for 180 days.

Section 4 Procedure for the amendment of a product not subject to authorization art. 16. for a biocidal product that is allowed in a EU or EFTA Member State according to a procedure simplified and which, in accordance with the art. 13 c and 13d OBP, can be placed on the market without authorisation, obligations related to the placing on the market of the person responsible in the case of an amendment of the authorisation of the EU or EFTA shall apply by analogy for the placing on the market.
If necessary, the person responsible shall forward to you, 30 days prior to the placing on the market of the biocidal product, the summary of the characteristics of the product reviewed by the Member State of the EU or EFTA on the basis of the amended authorization.

You may at any time ask the person responsible for providing all of the information related to the implementation of a given change, particularly with respect to classification and labelling.

Section 5 entry into force art. 17. this order comes into force on September 15, 2014.

RO 2014 2755 SR 813.12 new content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).
New content according to chapter I of O of the DFI on August 31, 2015, in effect since Sept. 15. 2015 (2015 3073 RO).
Introduced by chapter I of O of the DFI on August 31, 2015, in force since 15, seven. 2015 (2015 3073 RO).

State on September 15, 2015

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