¹ An active substance is approved in accordance with Annex 2, c. 1, if it is foreseeable, having regard to the current state of scientific and technical knowledge, that, having regard to the approval criteria set out in the c. 2 and 3 of this Annex, the phytosanitary products containing this active substance comply with the conditions laid down in paras. 3 to 5.

² The primary purpose of the assessment of the active substance is to determine whether the approval criteria set out in the guidelines are met. 3.6.2 to 3.6.4 and 3.7 of Annex II to Regulation (EC) N ^O 1107/2009 ¹ If this is the case, the assessment will continue to determine whether the other approval criteria set out in the s are met. 2 and 3 of Annex 2.

³ Residues of plant protection products, resulting from an application in accordance with good plant protection practices and under realistic conditions of use, satisfy the following conditions:

A.

They have no adverse effect on the health of human beings, including vulnerable groups, or on the health of animals, taking into account the known cumulative and synergistic effects when the scientific assessment methods of these effects, accepted by the The European Food Safety Authority (EFSA) ² , are available, or on groundwater;

B.

They have no unacceptable effect on the environment.

⁴ Routine methods for measuring residues that are significant from the point of view of toxicology, ecotoxicology, the environment, or drinking water must exist. Analytical standards should be generally available.

⁵ A phytosanitary product, under conditions of application in accordance with good plant protection practices and under realistic conditions of use, satisfies the following conditions:

A.

It is suitable for the intended use;

B.

It has no immediate or delayed harmful effect on human health, including for vulnerable groups, or on animal health, directly or through drinking water (taking into account substances resulting from treatment of water), Foodstuffs, feedingstuffs or air, or effects in the workplace or other indirect effects, taking into account the known cumulative and synergistic effects when the scientific methods of assessment of such effects, accepted by EFSA, are available or on groundwater;

C.

It has no unacceptable effect on plants or plant products;

D.

It does not cause unnecessary suffering or pain in vertebrate animals to be combed;

E.

It has no unacceptable effect on the environment, particularly in light of the following, where the scientific evaluation methods of these effects, accepted by EFSA, are available:

1.

Its environmental fate and dissemination, in particular with regard to the contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil, taking into account remote areas of the Place of use, due to long-range transport in the environment,

2.

Its effect on non-target species, particularly on the persistent behaviour of these species,

3.

Its effect on biodiversity and the ecosystem.

⁶ The requirements of paras. 3 to 5 are assessed according to uniform principles set out in s. 17, para. 5.

⁷ For the approval of an active substance, the provisions of paras. 1 to 5 shall be deemed to be complied with if it has been established that this is the case for one or more representative uses of at least one phytosanitary product containing this active substance.

⁸ As far as human health is concerned, no data collected in humans is used for a reduction in safety margins established on the basis of studies or tests carried out on animals.

⁹ In derogation from para. 1, where, on the basis of documented evidence included in the application, an active substance is required to control a serious plant health hazard which cannot be controlled by other means available, including methods not available This active substance may be approved for a limited period necessary to control this serious hazard, even if it does not meet the criteria set out in the c. 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II to Regulation (EC) N ^O 1107/2009 ³ Provided that the use of the active substance is the subject of risk mitigation measures in order to minimise the risks to man and the environment. For these substances, the maximum residue levels were established in accordance with the Ordinance of 26 June 1995 on Foreign Substances and Components (OSEC) ⁴ . This derogation does not apply to active substances which, under Regulation (EC) No ^O 1272/2008 ⁵ , are or should be classified as category 1 carcinogens, category 2 non-threshold carcinogens, or category 1 toxic agents.

¹ The Federal Department of Economics, Training and Research (DEFR) ¹ Enters a new active substance on the list of approved active substances (Annex 1) when it has been examined as part of an application for authorisation to release a phytosanitary product and meets the criteria referred to Art. 4. ²

² For active substances, the OFAG may lay down the following conditions and restrictions: ³

A.

The minimum purity of the active substance;

B.

The maximum content of certain impurities and the nature of the impurities;

C.

Restrictions resulting from the assessment of the information referred to in Art. 7 taking into account the agricultural, phytosanitary and environmental conditions, including climatic conditions, considered;

D.

Type of preparation;

E.

The mode and conditions of application;

F.

The provision of additional confirmatory information, where new requirements are established during the assessment process or on the basis of new scientific and technical knowledge;

G.

The designation of categories of users, such as professionals and non-professionals;

H.

The designation of areas where the use of plant protection products, including soil treatment products, containing the active substance may not be registered or in which their use may be registered in certain Special conditions;

I.

The need to impose risk mitigation measures and post-use monitoring;

J.

Any other special condition resulting from the evaluation of the information provided in the context of this Regulation.

³ If an active substance meets one or more of the additional criteria set out in Annex 2, c. 4, the DEFR is listed in Annex 1, Part E, as a substance for consideration of substitution. ⁴

⁴ Active substances identified as low-risk active substances under s. 22 of the EC/1107/2009 Regulation ⁵ Are designated as such in Schedule 1. OFAG may refer to other low-risk active substances:

A.

If it is foreseeable that the phytosanitary products containing these active substances will present only a small risk to human health, animal health and the environment in accordance with Art. 32; and

B.

If these active substances are not to be classified in one of the categories set out in Annex 2, c. 5.

¹ The application for approval or amendment of the conditions for approval of an active substance shall be submitted to the approval service by the producer of the active substance and shall be accompanied by a summary record and a file Established pursuant to s. 7, para. 1 and 2, or a scientific justification for the non-disclosure of certain parts of these files; it must be demonstrated that the active substance meets the criteria for approval established in s. 4. A collective application may be made by an association of producers. Art. 16 is reserved.

² At the time of application, the person concerned may request, pursuant to s. 52, that certain information, including certain parts of the file, that it physically separates, be treated confidentially.

³ When filing the application, the applicant shall, at the same time, attach a complete list of the tests and studies submitted pursuant to s. 7, para. 2, and a list of applications for the protection of reports under s. 46.

⁴ The approval service may require the applicant to provide in a defined computer form the list of test reports and studies submitted at the time of the application and the list of test reports and studies for which protection Reports under s. 46 is requested.

¹ The summary folder includes the following items:

A.

Information on one or more representative uses, on a widespread crop, of at least one phytosanitary product containing the active substance, which demonstrates that the criteria for the approval of s. 4 are respected; where the information presented relates to a culture which is not very widespread, a justification for this should be provided;

B.

For each point of the data requirements applicable to active substances, summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies;

C.

For each point of the data requirements applicable to the plant health products, the summaries and results of the tests and studies, the name of their owner and of the person or institute that carried out the relevant studies and studies For the assessment of the criteria set out in s. 4, para. 2 to 5, for one or more phytosanitary products that are representative of the uses referred to in the paragraph, having regard to the fact that, in the case referred to in para. 2, the absence of data resulting from the limited number of proposed representative uses of the active substance may result in approval with restrictions;

D.

For each test or study involving the use of vertebrate animals, a justification of the measures taken to avoid animal testing and a repetition of tests on vertebrates;

E.

A checklist attesting that the file referred to in para. 2 is complete given the uses requested;

F.

The reasons why the test reports and studies submitted are necessary for the first approval of the active substance or for the modification of the conditions of its approval;

G.

Where applicable, a copy of an application for a maximum residue limit referred to in s. 7 of Regulation (EC) No 396/2005 ¹ Or a justification for the non-disclosure of such information;

H.

An evaluation of all the information presented.

² The complete file contains the full text of the various test reports and studies relating to all the information referred to in para. 1, let. B and c. It does not contain test reports or studies involving the voluntary administration of the active substance or the plant health product to human beings.

³ The OFAG can define the summary folder structure and the complete folder structure.

⁴ The data requirements referred to in paras. 1 and 2 shall include the conditions to be fulfilled by the active substances and the plant protection products set out in Annexes 5 and 6. The DEFR can adapt these annexes taking account of international requirements in this field, in particular those of the European Union (EU).

⁵ The author of the application attached to the file the scientific documentation accessible, validated by the scientific community and published in the last ten years preceding the date of submission of the file, concerning the side effects on the Health, the environment and non-target species of the active substance and its relevant metabolites.

¹ The approval service may review an approved active substance at any time. It takes into account the decision on the need to re-examine an active substance from new scientific and technical knowledge and control data, including when the review of authorisations under Art. 29, para. 1, evidence indicates that the fulfilment of the aims set out in the Ordinance of 28 October 1998 on the protection of waters (OWaters) ¹ Cannot be reached by other means. The approval service shall also take account of EU decisions in this field.

² If the approval service considers, in the light of new scientific and technical knowledge, that there is reason to believe that the substance no longer meets the criteria for approval under s. 4 or additional information required under s. 5, para. 2, let. F, have not been communicated, it shall inform the producer of the active substance and shall give the producer a time limit to allow it to submit its observations.

³ If the approval authority concludes that it is no longer satisfied with the approval criteria set out in s. 4 or additional information required under s. 5, para. 2, let. F, have not been communicated, it proposes to the DEFR to withdraw the approval of the active substance or to the OFAG to amend the conditions and restrictions referred to in s. 5, para. 2.

¹ Active substances which enter the composition of one or more authorised plant protection products may be re-evaluated.

² The DEFR, in agreement with the other departments concerned and after consultation with the interested parties, registers the active substances which need to be reassessed in Annex 10. It takes into account this effect of the EU's re-evaluation programme.

³ The holder of an authorization issued for a phytosanitary product containing an active substance listed in Annex 10 shall file a request for re-evaluation with the OFAG within three months from the date of registration Of the active substance in Annex 10. When the substance is re-evaluated in the EU, the deadline is six months.

⁴ This application must contain all documents that must be attached to the application for authorisation to release a phytosanitary product containing a new active substance. The considerations and decisions of the EU, insofar as they are available, must be attached to the request.

⁵ If the situation warrants, the OFAG may leave an additional period of up to six months to complete the file. Where the substance is re-evaluated in the EU, the additional time limit shall be twelve months.

⁶ Assessment services assess files in accordance with s. 24.

¹ DEFR radiates an active substance from Schedule 1:

A.

When it has been entered in Schedule 10 and no request for reassessment has been filed;

B.

Where the documents submitted do not meet the requirements of s. 21 including those in Annex 5;

C.

When the revaluation of the active substance shows that the requirements set out in s. 17 are not fulfilled. The conclusions of the EU reassessment must be taken into account.

² DEFR may desist from radiating an active substance from Schedule 1 when, for use, there is no alternative to the control of a pest and as long as there is no adverse effect on human health during use Comply with the requirements. The use of this substance is then limited to this use. Approval of the substances concerned is reviewed on a regular basis.

¹ A basic substance is approved if:

A.

It is not a substance of concern;

B.

It is not inherently capable of causing endocrine disrupting effects, neurotoxic effects, or immunotoxic effects;

C.

Its main purpose is not to be used for phytosanitary purposes, but it is nevertheless useful for plant protection, either directly or in a product consisting of the basic substance and a simple diluent and

D.

It has no immediate or delayed adverse effect on human or animal health or an unacceptable effect on the environment.

² With regard to the basic substances, the OFAG may, by analogy, fix the conditions and restrictions referred to in Art. 5, para. 2.

³ Macro-organisms that are considered exotic within the meaning of s. 3, para. 1, let. F, of the order of 10 September 2008 on the release into the environment ¹ And microorganisms cannot be approved as core substances.

DEFR enters a new basic substance on the list of approved base substances (Schedule 1, Part D) when it has been reviewed and meets the criteria set out in s. 10 A .

¹ Any person may apply for approval of a basic substance with the approval service.

² It must include the following documents:

A.

Where appropriate, assessments of the possible effects of the substance on human or animal health or on the environment, carried out in accordance with other legislation which does not govern plant health protection;

B.

Any other relevant information relating to its possible effects on human or animal health or the environment.

³ The approval service is seeking the advice of the evaluation services.

¹ The approval service may at any time review an approved basic substance.

² If it considers that there is reason to believe that the substance no longer meets the criteria set out in s. 10 A , it shall inform the circles concerned and give them a period of time to allow them to submit their observations.

DEFR radiates a basic substance from Schedule 1, Part D, when it no longer meets the criteria set out in s. 10 A .

¹ A safener or synergist is approved if it meets the requirements of s. 4.

² Art. 5 to 10 shall apply mutatis mutandis.

³ The DEFR may lay down, in Annexes 5 and 6, specific requirements relating to the file to be accompanied by a request for approval of a safener or a synergist.

The DEFR may establish a programme for the progressive review of synergists and safeners released prior to the date of entry into force of this Article. It takes into account this effect of the EU's re-evaluation programme.

Co-formulants that cannot be introduced into a phytosanitary product are listed in Annex 3 by the DEFR. It takes account of decisions on the subject of the European Union.

¹ A phytosanitary product may be put into circulation only if it has been approved in accordance with this order.

^1bis For the release of phytosanitary products whose development is based on the use of genetic resources or traditional knowledge associated with them, the provisions of the Nagoya Ordinance of 11 December 2015 ¹ Are reserved. ²

² In derogation from para. 1, no registration is required in the following cases:

A. ³

Release and use of plant health products for research or development purposes, in accordance with Art. 41; if the phytosanitary products are organisms or contain organisms, the provisions of the Ordinance of 9 May 2012 on Confined Use (OUC) ⁴ And the order of 10 September 2008 on the release into the environment (ODE) ⁵ Are reserved;

B.

Production, storage or release of a phytosanitary product intended for use in a third country;

³ The registration is valid for a phytosanitary product:

A.

A specified composition;

B.

A specific trade name;

C.

Intended for specified purposes;

D.

A specified producer.

The types of registration for plant protection products are:

A.

Approval on the basis of authorisation procedure (authorisation) (Sections 2 to 4);

B.

Registration on a list of phytosanitary products approved by a foreign country which correspond to the phytosanitary products authorised in Switzerland (section 5);

C.

Registration to control an emergency situation (Section 6).

D. ¹

Registration for plant protection products containing only approved basic substances (Section 6 A ).

Only a person who has his domicile or head office, or a branch, in Switzerland or who is domiciled in a State with which Switzerland has entered into an agreement with which Switzerland has entered into an agreement may file an application for registration or be the holder of an authorisation. These requirements do not apply.

¹ Subject to Art. 34, a phytosanitary product may only be authorized if, in accordance with the uniform principles set out in para. 5, it meets the following requirements:

A.

Its active substances, safeners and synergists are approved;

B.

Its active substance, safener or synergist has a different origin, or has the same origin but has undergone a change in its method or place of manufacture:

1.

But the specification does not deviate significantly from the specification of the substance or safener or synergist approved under s. 5, and

2.

The said substance or phytoprotective or synergist does not have any harmful effects in the sense of s. 4, para. 3 and 5, due to its impurities, if it had been produced according to the manufacturing process indicated in the dossier supporting the approval;

C.

Co-formulants are not included in Annex 3;

D.

The formulation (technical) is such that the user's exposure or other risks are limited to the extent possible without compromising the operation of the product;

E.

In the current state of scientific and technical knowledge, it complies with the conditions laid down in Art. 4, para. 5;

F.

The nature and quantity of its active substances, safeners and synergists, and, where appropriate, the impurities and coformulants of toxicological, ecotoxicological or environmental significance can be determined using methods Appropriate;

G.

Residues resulting from authorised uses, relevant from a toxicological, ecotoxicological or environmental point of view, can be determined using appropriate methods of common use, with appropriate detection limits on Relevant samples;

H.

Its physical/chemical properties have been determined and considered acceptable for the proper use and storage of the product;

I.

For plants or plant products, where appropriate, to be used as feed or food crops, the maximum residue levels applicable to the agricultural products concerned by the use referred to in the authorisation have been Established or modified in accordance with OSEC ¹ Or the order of 26 May 1999 on feed for animals ² .

² The applicant is required to demonstrate compliance with the requirements set out in para. 1, let. A to h.

³ Compliance with the requirements listed in para. 1, let. B and d to h shall be carried out by official or officially recognised tests and analyses, under agricultural, phytosanitary and environmental conditions corresponding to the use of the phytosanitary product in question and representative of the Conditions of use.

⁴ The OFAG may, in respect of para. 1, let. F, define harmonised methods; it takes into account the methods adopted by the EU.

⁵ The uniform principles for the assessment and authorisation of plant protection products are set out in Annex 9; they specify the requirements referred to in par. 1. DEFR can adapt Annex 9.

⁶ The interaction between the active substance, safeners, synergists and co-formulants should be taken into account in the assessment of plant protection products.

⁷ A phytosanitary product is also permitted only:

A.

If it does not contain organisms considered to be invasive alien organisms within the meaning of s. 3, let. H ³ Annex 2 to the ODE;

B.

The identity and biological characteristics of the micro-organisms and the macro-organisms contained therein are sufficiently known;

C.

If it does not contain a mixture of active substances to control different groups of harmful organisms such as insects, fungi or weeds.

⁸ Exceptions to the requirements set out in para. 7, let. C, can be made for seed treatment products and plant protection products used in the forest to treat cut wood.

⁹ Phytosanitary products consisting of genetically modified organisms or containing such organisms are only permitted if they meet the requirements of the ODE.

¹⁰ The OFAG may refuse to grant an authorization, or may attach such charges or conditions, if it appears that precautionary measures are applicable under s. 148 A LAgr.

¹¹ The approval service may authorise, for a maximum of two years and with the exception of plant protection products which consist of pathogenic organisms or contain such organisms, a phytosanitary product, the substance of which Not yet listed in Schedule 1, if the product in question meets the requirements set out in par. 1, let. B to i, 5 and 9. It shall forward to the Federal Office of the Environment (OFEV) the relevant documents and the outcome of its examination for opinion.

¹ The approval service shall decide on the application for authorisation by way of decision.

² Authorization defines plants or plant products and non-agricultural areas (p. Ex. Railways, public areas, places of storage) on which the plant health product may be used and the purposes for such use.

³ The authorization sets out the requirements for the release and use of the phytosanitary product. These requirements shall include, at a minimum, the conditions of employment necessary to comply with the conditions and requirements referred to in Art. 5, para. 2.

⁴ The authorisation shall include a classification of the phytosanitary product according to Annex 1, parts 2 to 5 of Regulation (EC) No ^O 1272/2008 ¹ , which corresponds to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). ²

⁵ The decision, provided that the application is accepted, includes in particular the following indications:

A.

The home, head office or branch of the applicant;

B.

The trade name under which the phytosanitary product can be put into circulation;

C.

The name of each active substance and its quantity expressed in metric units and type of preparation;

D.

For micro-organisms and macro-organisms, the identity of each organism and its quantity expressed in appropriate units;

E.

The duration of validity of the authorization;

F.

The federal registration number.

⁶ The requirements referred to in para. 3 also includes, where applicable:

A.

The maximum dose per hectare for each use,

B.

The time to be met between the last use and the harvest;

C.

The maximum number of uses per year;

D.

Restrictions on the distribution and use of the plant health product in order to ensure the protection of the health of distributors, users, persons present on the premises, inhabitants, consumers or workers Concerned or the environment; such restrictions are indicated on the label;

E.

The designation of categories of users, such as professionals and non-professionals;

F.

The time between uses;

G.

The re-entry period.

⁷ The authorisation applies to the holder mentioned in the decision and is not transferable.

The authorization is issued for ten years subject to s. 29.

¹ At the request of the holder of the authorisation, the approval service may confirm the authorisation to release a phytosanitary product in Switzerland by establishing a certificate.

² At the request of the holder of the authorisation, the approval service may confirm with an export certificate that a phytosanitary product intended for export is manufactured in Switzerland. In such cases, it shall consult the State Secretariat for Economic Affairs (SECO) in advance, to the extent that the area of competence of the latter is affected.

¹ Any applicant wishing to put a phytosanitary product in circulation is required to file an application for authorisation or amendment of an authorisation in person or through a representative to the approval service.

² The request includes the following:

A.

The home, head office or branch of the applicant;

B.

The trade name under which it is intended to put the phytosani-taire in circulation;

C.

The place of manufacture, packaging or repackaging of the phytosanitary product;

D.

The name and address of the manufacturer of the plant health product and the active substances contained therein;

E.

A list of proposed uses;

F.

Where appropriate, a copy of any authorisation already granted to the phytosanitary product in an EU State;

G.

Where appropriate, a copy of any conclusion of an EU Member State which has evaluated the equivalence of active substances, safeners and synergists used.

³ The following are attached to the application:

A.

For the phytosanitary product concerned, a complete dossier and a summary dossier for each point of the data requirements applicable to the phytosanitary product;

B.

For each active substance, safener and synergist contained in the plant health product, a complete dossier and a summary dossier for each point of the data requirements applicable to the active substance, to the safener And the synergist;

C.

For each test or study involving the use of vertebrate animals, a justification of the measures taken to avoid animal testing and a repetition of tests on vertebrates;

D.

The reasons why the test and study reports submitted are necessary for a first authorization or for amendments to the conditions of the authorization;

E.

Where applicable, a copy of the application for a maximum residue limit referred to in s. 7 of Regulation (EC) No 396/2005 ¹ Or a justification for the non-disclosure of such information;

F.

Where appropriate, for the modification of an authorisation, an assessment of all the information communicated pursuant to Art. 7, para. 1, let. H;

G.

A labelling project.

⁴ The other requirements to be met by the application package are set out in Annex 6.

⁵ Where a phytosanitary product contains active substances that are not yet listed in Schedule 1 or that the data relating to active substances, safeners or synergists are protected under s. 46, the documents listed in Schedule 5 must be filed.

⁶ The approval service may, on a case-by-case basis, impose additional requirements on the content of the dossier accompanying the application.

⁷ It may, in agreement with the evaluation services, waive the request for certain parts of the file, including certain studies, if the applicant can prove that these documents are not necessary for the assessment of the phytosanitary product.

⁸ If the application for authorisation relates to a phytosanitary product consisting of genetically modified organisms or containing such organisms, it must meet the additional requirements laid down in Art. 28 and 34, para. 2, ODE ² .

^8bis If the request for authorization is for a phytosanitary product consisting of, or contenting, a macro-organism, it must meet the requirements of the EPPO PM6/2 standard ³ . ⁴

⁹ Documents attached to the application must be filed:

A.

On paper or on electronic media;

B.

In one of the official or English languages. If the application relates to a phytosanitary product consisting of pathogenic or genetically modified organisms or containing such organisms, at least one summary of the application must be provided in one of the official languages.

¹⁰ At the time of application, the person concerned may request, pursuant to s. 52, that certain information, including certain parts of the file, that it physically separates, be treated confidentially. At the same time, it presents the complete list of studies submitted pursuant to Art. 7, para. 2, and a list of the reports of tests and studies for which applications for the protection of the reports have been submitted in accordance with Art. 46.

¹¹ In the context of a request for access to information, the approval service shall determine the information to be kept confidential.

¹² The applicant, if invited, shall provide samples of the phytosanitary product and the standards for the analysis of its ingredients.

¹³ The approval service may require the applicant to provide, in a defined computer form, the list of test reports and studies submitted at the time of the application, as well as the list of test reports and studies for which the application is submitted. Protection of reports under s. 46, is requested.

¹ Applicants are exempt from providing the test and study reports referred to in s. 21, para. 3, where the certification service has the test and study reports in question and the applicants demonstrate that access was granted to them in accordance with s. 46 or the possible period of protection of the reports has expired.

² However, the applicants to whom s. 1 applies to provide the following information:

A.

All data necessary for the identification of the phytosanitary product, including its complete composition, as well as a statement indicating that no co-formulants listed in Annex 3 are used;

B.

The information necessary to identify the active substance, safener or synergist, if approved, and to determine if the conditions of approval are met and are in accordance with s. 17, para. 1, let. B, if applicable;

C.

On request of the approval service, the data necessary to demonstrate that the phytosanitary product has effects comparable to those of the phytosanitary product for which they provide evidence of their access to the protected data.

¹ The approval service examines whether the application is complete.

² Where parts are missing or fail to meet the requirements, the approval service shall provide the applicant with an appropriate period of time to complete it. If the required indications are not provided within the time limit, the application shall be rejected.

³ The registration service transmits the application and the relevant documents to the evaluation services.

⁴ If the application relates to a phytosanitary product consisting of genetically modified organisms or containing such organisms, the approval service shall initiate the authorisation procedure taking into account the ODE ¹ .

⁵ If it relates to a phytosanitary product which consists of non-genetically modified organisms, or contains such organisms, the publication, the consultation of non-confidential documents and the procedure shall be governed by Art. 42 and 43 ODE to the extent that organizations are not listed in Schedule 1.

¹ The assessment services shall consider whether the conditions laid down in Art. 17 are completed and evaluate the documents in light of the criteria set out in Annex 9.

² In the evaluation of an active substance, a synergist or a safener already approved in the EU, the approval service and evaluation services shall take into account the outcome of the EFSA evaluation, considerations and Decisions by the EU concerning the approval of these substances and the considerations and decisions of the Member States concerning the authorisation of plant protection products containing these substances, provided that these documents are presented to the Certification service or brought to its attention.

³ During the examination of the application, the approval service may conduct or cause tests and other investigations.

⁴ The assessment services shall communicate to the approval service the result of their assessment.

The approval service instructing the applicant to provide him with samples or additional information, including additional data and test results, where the examination of the file shows that these additional information are Necessary.

² If the approval service requires that the file be completed, the time limits shall cease to run until the additional information has been filed.

The holder of the authorization shall keep, for at least ten years from the date of the last transfer of the phytosanitary product, a copy of all documents filed or to ensure that the documents deposited are available. Samples are retained for as long as their condition permits an assessment.

¹ The authorization may be renewed.

² The application for renewal of the authorisation must be filed with the approval service two years before the end of the period of validity of the authorisation. The requester provides the following information:

A.

A copy of the phytosanitary product authorization;

B.

Any new information that has become necessary due to changes in data requirements or criteria;

C.

Evidence that the new data submitted are based on data requirements or criteria that were not applicable at the time the phytosanitary product authorization was granted or are necessary to amend the data Approval conditions;

D.

Any information necessary to demonstrate that the phytosanitary product meets the requirements set out in the approval of the active substance, safener or synergist contained therein;

E.

A report on monitoring information, if the authorization was subject to monitoring.

³ The information referred to in Art. 22, para. 2, let. A and b, shall be provided by each holder of an authorization upon renewal of the authorization.

⁴ The approval service shall examine whether the conditions for granting the authorisation are met. Where appropriate, it shall require additional information, including the results of additional tests or tests necessary for the assessment of the safety of the plant health product and its conformity with the intended use.

⁵ It shall refuse renewal when the conditions for grant are no longer fulfilled or the additional information is not provided on time.

⁶ It has the power to extend the authorisation pending the decision on renewal.

¹ The approval service may re-examine an authorization at any time if certain elements suggest that one of the requirements set out in s. 17 is no longer respected. The approval service reviews an authorisation when it concludes that the goals set by the OWaters ¹ Cannot be reached by other means.

² Where the approval service intends to withdraw or amend an authorisation, it shall inform the holder and give it the opportunity to submit comments or additional information.

³ The approval service shall withdraw or amend the authorisation, as the case may be:

A.

Where the requirements under s. 17 are not or are no longer respected;

B.

Where false or misleading information has been provided on the facts supporting the authorization granted;

C.

Where a condition in the authorization is not met;

D.

When, given the evolution of scientific and technical knowledge, the mode of use and the quantities used can be modified;

E.

Where the holder of the authorization fails to comply with his or her obligations under this order;

F.

When the conditions for the implementation of the precautionary measures referred to in s. 148 A LAgr are completed.

⁴ The approval service may re-examine at any time the plant protection products containing an active substance, safener or synergist for which the EU has set conditions or restrictions on approval or renewal Of approval. It may require holders of authorisations, the data necessary for the assessment of such conditions or restrictions, including relevant information relating to the active substance, safener or synergist, and set a time limit For delivery. It may amend or withdraw an authorisation or attach new charges directly on the basis of the available results of the approval or renewal procedure for the approval of the EU.

⁵ The approval service shall carry out the review referred to in para. 4 as a priority for substances for which the conditions and restrictions laid down by the EU at the time of approval concern the protection of groundwater.

¹ An authorization may be withdrawn or amended at the request of the holder of the authorization.

² Amendments may be granted only where it is found, in respect of such applications and in accordance with the procedure referred to in Art. 23 and 24, that the requirements set out in s. 17 are respected.

¹ Where the approval service withdraws an authorisation or does not renew it and the reasons for withdrawal or non-renewal are not related to a potential dangerous effect deemed unacceptable, it may grant a time limit for the implementation of the Circulation of existing stocks.

² The time limit shall not exceed twelve months for the release of the existing stocks of the phytosanitary products concerned.

³ In the event of withdrawal of the authorisation or non-renewal due to immediate concerns regarding human or animal health or the environment, the phytosanitary products concerned shall be immediately withdrawn from the market.

¹ When all active substances contained in a phytosanitary product are low-risk active substances under s. 5, para. 4, this product is allowed as a low-risk pest control product provided that specific risk mitigation measures are not required as a result of the risk assessment. This phytosanitary product also meets the following conditions:

A.

The active substances, safeners and synergists contained therein, have been approved under chap. 2;

B.

It does not contain a worrisome substance;

C.

It is effective enough;

D.

It does not cause unacceptable pain or suffering in vertebrates to be combed;

E.

It meets the requirements set out in s. 17, para. 1, let. B, c and f to i.

² Any person seeking the authorization of a low-risk pest control product is required to demonstrate compliance with the requirements set out in para. 1 and attach to the application a complete file and a summary record for each point of the data requirements applicable to the active substance and the phytosanitary product. Art. 22 is reserved.

¹ Seed may not be imported as a commercial commodity when treated with active substances not authorized in Switzerland for the intended use.

² The approval service may grant derogations provided that the products concerned are authorised in the EU. It makes a general decision that is published in the Federal Worksheet. The validity of this decision is generally limited to one year.

³ In addition to the labelling requirements defined in Art. 17 of the order of 7 December 1998 on propagating material ¹ , the label and the documents accompanying the treated seeds shall bear the following particulars:

A.

The name of the phytosanitary product with which the seed was treated;

B.

The name of the active substances contained in the phytosanitary product;

C.

The standard sentences for the precautionary statements provided for in Annex IV, Part 2, of Regulation (EC) No ^O 1272/2008 ² ; and

D.

Where applicable, the risk mitigation measures set out in the phytosanitary product authorization. ³

¹ The evaluation services conduct a comparative assessment in the course of the review, in accordance with s. 8, an active substance approved as a substance for consideration for substitution or for review in accordance with s. 29, para. 4, of a phytosanitary product containing such a substance. The approval service shall withdraw or limit the authorisation of a phytosanitary product in a particular crop, where it is apparent from the comparative assessment weighing the risks and benefits, as described in Annex 4: ¹

A.

There is already, for the uses specified in the application, an authorized phytosanitary product or a non-chemical method of prevention or control that is significantly safer for human or animal health or the environment;

B.

Substitution by phytosanitary products or non-chemical methods of prevention or control referred to in the letter. Has no major economic or practical disadvantages and has comparable effects on the target organism;

C.

That the chemical diversity of active substances, where appropriate, or the methods and practices of crop management and prevention of pests are likely to reduce the occurrence of resistance in the organism as much as possible Target; and

D.

The impact on authorisations for minor uses is taken into account.

² The evaluation services shall carry out a comparative assessment for any new request for authorisation for a phytosanitary product containing an active substance which has already been the subject of a comparative assessment in accordance with para. 1. The evaluation is not carried out for indications which have already been the subject of such an evaluation in this context. ²

³ The comparative assessment referred to in paras. 1 and 2 is not performed in the following cases:

A.

Minor uses;

B.

Uses with an insufficient number of active substances to allow an effective anti-resistance strategy. ³

⁴ When the approval authority decides to withdraw or amend an authorization under para. 3, the withdrawal or modification in question takes effect three years after the decision or at the end of the approval period for the substance for which substitution is being considered, when that period ends earlier.

⁵ Unless otherwise specified, all the provisions relating to the authorisations contained in this order shall apply.

⁶ The DEFR may adapt the procedure for the comparative assessment of a phytosanitary product set out in Annex 4 in order to take account of developments in this procedure at international level.

¹ Where the application for authorisation relates to a minor use, the approval service may waive compliance with the conditions laid down in Art. 17, para. 1, let. B to g, et al. 2 and 3, and to authorize the phytosanitary product:

A.

If authorised, for the minor uses considered, in an EU Member State in which the agronomic, climatic and environmental conditions are comparable; or

B.

If there is already an authorization in Switzerland for similar uses.

² The application shall indicate the conditions under which there is minor use and shall contain only the particulars referred to in Art. 21, para. 2, let. A to d. In the cases referred to in para. 1, let. A, it must also establish that the phytosanitary product is authorised in an EU Member State for the minor use concerned.

³ The approval service may refuse to grant authorisation if general knowledge suggests that the requirements of s. 17 are not fulfilled.

⁴ This Article does not apply to genetically modified organisms.

¹ The approval service establishes a list of phytosanitary products registered abroad which correspond to the phytosanitary products authorised in Switzerland. Phytosanitary products on this list are considered to be registered.

² A phytosanitary product registered abroad is listed on the list:

A.

Where it has decisive properties similar to a phytosanitary product authorised in Switzerland, in particular the same content of active substances and the same type of preparation;

B.

When it has been registered abroad on the basis of requirements equivalent to the Swiss conditions and the agronomic and environmental conditions relating to its use are comparable to those in Switzerland;

C.

When it does not consist of, or contains, pathogenic or genetically modified organisms;

D.

Where the holder of the authorization of the phytosanitary product authorised in Switzerland (reference product) has not been able to establish plausibly that the product is patented and, if so, that the product approved abroad has been put into Movement without the consent of the owner of the patent within the meaning of s. 27 B LAgr; and

E.

Where the holder of the authorisation of the phytosanitary product authorised in Switzerland, for which a report is protected within the meaning of Art. 46, could not plausibly establish that the product registered abroad was put into circulation without the consent of the representative or supplier abroad of the holder of the authorization.

³ Proposals for inclusion in the list shall be submitted to the approval service. They shall be accompanied by the information referred to in section 3 of the safety data sheet referred to in Art. 20 of the Chemicals Ordinance of 5 June 2015 (OChim) ¹ If necessary, the approval service may request additional information. ²

¹ The approval service examines whether the conditions are met. It relies on the data on the list of phytosanitary products in the country of origin. It takes into account further information when it is at its disposal.

² It shall provide the holder of the authorization of the reference product with a period of 60 days to establish plausibly:

A.

The existence of a patent protecting the reference product;

B.

If that is the case, that the phytosanitary product registered abroad is put into circulation outside Canada without the consent of the owner of the patent within the meaning of s. 27 B LAgr; and

C.

When a report for that product is protected within the meaning of s. 46, that the product registered abroad is put into circulation without the consent of the representative or supplier outside Canada of the holder of the authorization.

³ The registration service registers the phytosanitary product on the list by a decision of general application.

⁴ The decision is published in the Federal Worksheet, including:

A.

The country of origin of the phytosanitary product;

B.

The trade name under which the phytosanitary product can be put into circulation;

C.

The name of the foreign authorization holder;

D.

Storage and disposal requirements;

E.

The precise designation of all active substances contained in the product and their contents, expressed in metric units;

F.

Type of preparation;

G.

The Federal Phytosanitary Product Licence Number;

H.

Where applicable, the approval number assigned in the country of origin.

⁵ The indications concerning the potential for use of the phytosanitary product and the charges related to this use are those of the authorised reference plant product in Switzerland. They shall be laid down in the employment notices issued by the approval service and published in accordance with Art. 45. They are automatically modified in the event of changes in the use or expense of using the reference product.

¹ The approval service shall order the cancellation of a phytosanitary product from the list:

A.

When it is no longer registered in the country of origin; or

B.

Where no phytosanitary products with similar determinative properties are allowed in Switzerland.

² The approval service may radiate a phytosanitary product when the requirements set out in s. 36 are no longer satisfied.

³ Where the reasons for the cancellation are not related to a potential dangerous effect which is considered unacceptable, it may grant a time limit for the release of existing stocks which do not exceed twelve months.

¹ Any person who imports a phytosanitary product from the list referred to in s. 36 shall communicate it to the competent authority within three months of the first release.

² The content and form of the communication are set out in Art. 49 to 51 OChim ¹ . ²

³ The obligation referred to in para. 1 does not apply to products imported by end users.

¹ The approval service may register phytosanitary products for limited and controlled use, in derogation from Sections 2 to 4, where such a measure seems necessary due to a phytosanitary hazard which cannot be controlled by Other means.

² It may register a phytosanitary product when it considers that the conditions laid down in Art. 17, para. 1, let. E and i are satisfied, as well as the conditions set out in s. 17, para. 7, let. B, if it is an organization; at the time of the evaluation, it takes into account the facts and generally known data.

³ Phytosanitary products consisting of genetically modified organisms or containing such organisms may not be registered in accordance with the procedure referred to in para. 1.

⁴ The approval service makes a general decision that is published in the Federal Worksheet.

⁵ The approval shall be granted for a period of up to one year. It can be renewed.

⁶ The approval service shall inform the cantonal enforcement authority of the approvals granted for the control of emergency situations.

¹ Phytosanitary products which contain only the basic substances listed in Annex 1, Part D, and which comply with the conditions and restrictions laid down therein may be put into circulation without authorisation.

² The release of phytosanitary products which do not contain only basic substances shall be governed by Sections 2 to 6.

A person who manufactures or imports a phytosanitary product containing only approved basic substances shall communicate it to the approval service before the first release. The communication must contain the following:

A.

The trade name;

B.

The name and address of the manufacturer or importer;

C.

The precise designation and quantity of all approved base substances;

D. ¹

Where applicable, the particulars referred to in Art. 55 A , let. F.

¹ Experiments or tests carried out for the purpose of research or development involving the emission into the environment of a phytosanitary product not approved or involving the unauthorized use of a phytosanitary product shall not Take place only if the approval service has evaluated the available data and issued a permit to conduct tests. This permit may limit the quantities to be used and the areas to be treated, and impose additional conditions to prevent any adverse effects on human or animal health or any unacceptable adverse effects on the environment, In particular the need to prevent feed and food containing residues from entering the food chain unless a maximum value has already been set in the OSEC ¹ .

² An application is made to the approval service. It shall be accompanied by a file containing all the information available to assess the potential effects on human or animal health or the possible effects on the environment.

³ L' al. 2 shall not apply if the approval service has recognised the right of the person concerned to undertake certain experiments and tests and has determined the conditions under which such experiments and tests must be carried out.

⁴ In testing with genetically modified organisms or pathogenic organisms subject to the ODE authorization regime ² , the authorisation procedure is governed by the ODE.

⁵ If it is intended to conduct tests for which macro-organisms are used, and for which the authorisation procedure is not governed by para. 4, the approval service consults the OFEV before any decision is taken.

¹ Anyone who uses for research or development an unauthorized phytosanitary product must register:

A.

The identity and provenance of the phytosanitary product;

B.

Labelling particulars;

C.

Quantities delivered;

D.

The name and address of the person who received the phytosanitary product;

E.

All available information on possible effects on humans, animals and the environment;

F.

Indications concerning the type, location and timing of use.

² Upon request, the registered information shall be made available to the approval service.

¹ An authorized phytosanitary product for which a sales permission has been granted may be released under the name of the holder of the sales permission and under a trade name other than that of the authorized product. The sales permission is only valid for the applications mentioned in the authorization.

² Permission to sell shall be granted if the holder of the authorisation has given his consent. It has a federal registration number.

³ It shall become moot as soon as the authorisation is extinguished or the authorisation holder withdraws his consent. The holder of the authorisation shall inform the approval service when he withdraws his agreement.

⁴ Requests for permission to sell are addressed to the approval service. The application must be accompanied, in particular, by the written consent of the holder of the authorisation.

¹ The holder of an authorisation for a phytosanitary product shall immediately inform the approval service of any new information concerning the phytosanitary product, the active substance, its metabolites, a safener, a synergist Or a co-formulant contained in this product and signifying that the phytosanitary product no longer meets the criteria set out in s. 4 and the conditions laid down in Art. 17. It shall indicate, in particular, the potentially harmful effects of this phytosanitary product, or residues of an active substance, its metabolites, a safener, a synergist or a co-formulant contained in this product, on human health Or on groundwater, or their potentially unacceptable effects on plants or plant products or on the environment. To this end, the authorisation holder shall record and report all adverse reactions, in humans, in animals and in the environment, suspected of being linked to the use of the phytosanitary product. The obligation to notify includes the provision of relevant information on decisions or assessments of international organisations or public bodies that permit plant protection products or active substances in countries Third parties.

² The notification shall include an assessment of whether and, if so, how the new information means that the phytosanitary product or active substance, its metabolites, a safener, a synergist or a co-formulant Meets the criteria set out in s. 4 or the conditions set out in s. 17.

³ The holder of an authorisation shall also inform the approval service of any change concerning the origin or composition of an active substance, a safener, a synergist or a plant health product.

⁴ The holder of an authorisation for a phytosanitary product shall each year communicate to the approval service any information available on a lack of effectiveness in relation to the expected results, the appearance of a resistance and any effect Unexpected plants, plant products or the environment.

⁵ It shall announce to the approval service any change involving a change in the classification and labelling of the phytosanitary product. ¹

¹ For phytosanitary products authorised or withdrawn in accordance with this order, as well as for products for which a sales permit has been granted, the approval service shall provide electronic access to the public Information containing at least the following:

A.

The name or name of the holder of the authorization and the approval number;

B.

The trade name of the product;

C.

Type of preparation;

D.

The name and quantity of each active substance, safener or synergist contained in the product;

E. ¹

The relevant warning statement in accordance with the classification referred to in Annex I, Parts 2 to 5, the hazard statements referred to in Annex III and the hazard pictograms referred to in Annex V to Regulation (EC) No ^O 1272/2008 ² ;

F.

The use or uses for which the product is authorized;

G.

List of minor uses referred to in s. 35;

H.

The requirements for use under s. 18, para. 3 and 6.

² The information referred to in para. 1 must be easily accessible and updated at least every three months. They may not contain confidential information.

³ The approval service may publish, for these plant protection products, a summary sheet listing the possible applications and their specific properties. This record should not contain confidential data.

⁴ In collaboration with the federal agricultural research stations, the approval service shall inform the competent cantonal authorities as well as the agricultural sector concerned of the developments concerning the approvals, as well as the Characteristics and possible applications of plant protection products.

⁵ It publishes the list of plant protection products which contain only approved basic substances. It contains the information referred to in Art. 40 B . ³

¹ The OFAG is the registration service for phytosanitary products.

² A Steering Committee shall be established for the approval service. It includes the Directors of the following Federal Offices:

A.

Federal Office for Food Safety and Veterinary Affairs (FVO) ¹ ;

B.

OFAG;

C.

OFEV

D.

SECO.

³ The steering committee has the following tasks and competencies:

A.

Defining the strategy of the approval service;

B.

It has a right of scrutiny in the organisation and calculation of the resources of the approval service.

⁴ The Steering Committee shall take its decisions by mutual agreement.

¹ The evaluation services are:

A.

OFAG;

B.

OSAV;

C.

OFEV;

D.

SECO.

² OFAG, in collaboration with its agricultural research stations and the Federal Institute for Forest, Snow and Landscape Research (NPF), ensures that the phytosanitary product:

A.

Is suitable for the intended use and does not produce unacceptable side effects on plants and crops when used in accordance with the requirements;

B.

Does not have unacceptable side effects on human and animal health or on the environment when used in accordance with the requirements.

³ The FVO has the following tasks:

A.

Ensures that a phytosanitary product, when used in accordance with the requirements, does not pose a risk to the health of the human being;

B.

It ensures that a phytosanitary product, when used in accordance with the requirements, has no unacceptable side effects, with regard to possible residues in or on foodstuffs;

C. ¹

It determines the labelling and classification of the phytosanitary product according to the requirements of health protection.

⁴ The OFEV determines the labelling and classification of the phytosanitary product according to the threat it poses to the environment.

⁵ Before entering into Annex 1 an active substance contained in a phytosanitary product subject to authorisation or when an active substance is re-evaluated, the approval service shall, for the opinion of the Office, provide the relevant documents as well as The conclusions of the evaluation. The cooperation of the OFEV is governed by Art. 62 A And 62 B The Act of 21 March 1997 on the organisation of government and administration ² .

⁶ If the phytosanitary product consists of genetically modified organisms or contains such organisms, the tasks of OFEV shall be governed by the ODE ³ .

⁷ The SECO evaluates phytosanitary products according to the health and safety requirements of users when the products are used for professional or commercial purposes. To this end, it is based on the toxicological assessment of the plant health product carried out by the FVO and on the exposure data, using recognised models where possible.

⁸ The evaluation services shall take account of the technical documents and other guidance documents adopted by the EU for the evaluation of plant protection products.

¹ The approval service has the following tasks:

A.

Coordinates the collaboration of evaluation services;

B.

It seeks the assessment and advice of the relevant evaluation services;

C.

It shall decide, after agreement with the evaluation services and to the extent that their field of competence is concerned, on applications for the authorisation of plant protection products.

² Before placing a phytosanitary product on the list referred to in s. 36 or the registration of a phytosanitary product in order to control an emergency under s. 40, the approval service shall require the opinion of the assessment services whose area of competence is concerned.

³ It shall direct and coordinate the procedure for the approval of plant protection products consisting of genetically modified organisms or containing such organisms, taking into account the ODE ¹ If field tests are to be carried out for the issuance of the authorisation, the tests shall be carried out only if the requirements of the EDO are met.

⁴ It shall rule on the modification or withdrawal of an authorisation:

A.

On its own initiative;

B.

On the request of an assessment service, provided that the reason for the request falls within its area of competence.

⁵ The evaluation services participating in the approval procedure shall regularly and regularly inform each other of facts and knowledge relating to the approval and use of plant protection products.

⁶ The approval service may, together with the cantonal implementing authorities, organise controls on the release or use of specific plant protection products.

The toxicological information centre is the Swiss Centre for Toxicological Information (CSIT).

¹ The OFAG, after consulting the Swiss Accreditation Service (SAS), establishes the procedure for certifying the conformity of tests with the requirements on good experimental practice.

² The OFAG, or the service designated by the OFAG, certifies on request the conformity of the tests. The fees of the applicant are set out in the order of 10 March 2006 on the emoluments of the State Secretariat for the Economy in the field of accreditation ¹ .

The approval service may appeal to experts for the execution of this order.

¹ Import of phytosanitary products on a professional or commercial basis requires a General Import Permit (MGI). This is issued by the approval service.

² The PGI is issued to persons who have made the request in writing and who have their domicile, head office or branch in Switzerland, or who are nationals of a State with which Switzerland has concluded an agreement providing that the two countries Waive these requirements.

³ It is of unlimited duration, personal and non-transferable. In serious cases, in particular in cases of misuse, it may be withdrawn.

⁴ The person subject to the obligation to report must indicate the importer's GI number in the customs declaration.

⁵ The approval service shall inform the cantonal authorities of the holders of an ERP who have their domicile or have their headquarters in the territory of their canton.

At the request of the approval service, the customs offices shall verify that the phytosanitary products comply with the provisions on the importation of this order. For the rest, art. 83, para. 3, OChim ² Is applicable.

The fees collected for the administrative acts covered by this order and the method of calculation shall be governed by the order of 7 December 1998 on emoluments received by the Federal Office for Agriculture ¹ .

¹ The cantons are responsible for monitoring the market for plant protection products and ensuring that plant protection products are used in accordance with the requirements. OFAG performs these tasks only in the alternative.

² In particular, the cantons shall monitor compliance with:

A.

Decisions made under s. 18 and 37;

B.

Requirements concerning packaging, labelling, safety data sheet and advertising (Art. 54 to 60);

C. ¹

Requirements concerning the duty of care (art. 61), conservation (art. 63), surrender (art. 64), theft, loss and error in circulation (art. 65), restrictions on use (art. 68) and the obligation to resume (art. 70).

³ They shall ensure that the prohibitions of use referred to in s. 67 are executed.

¹ If there are reasonable grounds to believe that a phytosanitary product put into circulation or intended for use does not comply with the provisions of the Act, the Act, the Act, the Act, this Order, or the implementing provisions of Such acts, the competent authority may seize the means of evidence, block or confiscate the goods or require the importer to re-export it.

² Any person who holds evidence under s. 1 is required to produce them on request.

³ The authority labels the seized objects and puts them on a list. It provides the owner of the object with a copy of this list.

⁴ The authority that orders a measure under para. 1 shall arrange for the maintenance of the objects. It may give instructions to persons who have rights on these objects to this effect.

⁵ The authority may confiscate seized objects and the phytosanitary products concerned or authorize their export.

Art. 74 to 76 OChim ² Apply by analogy to the transmission of data concerning plant protection products.

The approval service establishes interdisciplinary documentation on plant protection products, which includes, inter alia:

A.

All documents filed in support of the application;

B.

All documents produced by the evaluation services that are relevant to the assessment;

C.

Conclusions of evaluations, including the statement of authorities and other decisions;

D.

All correspondence exchanged with the applicant;

E.

Files relating to legal aspects and procedures.

The order of 18 May 2005 on the release of plant protection products ¹ Is repealed.

... ¹

¹ The conditions for the registration of active substances in Schedule 1 under the old law shall apply after the entry into force of this order:

A.

Applications for approval of active substances for which a decision has been adopted pursuant to s. 6, para. 3, of Directive 91/414 EEC ² Before June 14, 2011;

B.

Requests for approval, review or re-evaluation of substances that are considered to be admissible in accordance with s. 16 of Regulation (EC) No 33/2008 ³ ;

C.

Requests for approval, review or re-evaluation of substances that are considered to be admissible in accordance with s. 6 of Regulation (EC) No 33/2008 ⁴ Before June 14, 2011.

² Authorisations issued before the entry into force of this Ordinance shall remain valid. They shall end no later than 31 July 2015, unless another date has been fixed in accordance with the provisions in force before the entry into force of this order.

³ Phytosanitary products that have been labelled and packaged in accordance with the law in force before 1 ^Er August 2005 can be used until July 31, 2011.

⁴ DEFR may extend the time limits set out in para. 1 when an extension of these deadlines has been decided in the EU.

⁵ Safeners and synergists already in circulation prior to the coming into force of this order shall be announced with the approval service within twelve months of the coming into force of this order.

⁶ Notwithstanding s. 17, para. 1, let a, a phytosanitary product containing a synergist or a safener already in circulation before the coming into force of this order may be authorized pending the outcome of the review procedure referred to in s. 12.

⁷ The provisions of Art. 48, para. 1 and 2 do not apply to the phytosanitary substances and products for which an application was filed prior to the coming into force of this order.

¹ Phytosanitary products that have been labelled and packaged under the old right may:

A.

Be put into circulation until 31 May 2018;

B.

Be used until October 31, 2020.

² Proposals for classification and labelling must be filed until 31 December 2014 with the approval service so that it can decide before the middle of 2017 of a new classification and labelling According to Regulation (EC) No ^O 1272/2008 ² , which corresponds to the GHS. If the approval service cannot decide on the new classification and labelling before mid-2017, it may extend the time limits set out in para. 1 for the product concerned.

³ ... ³

For plant protection products which, in accordance with Art. 86 A , para. 1, have been labelled and packaged according to the old right, security data sheets established under the old right may be submitted until May 31, 2018.

¹ The application package for the registration of an active substance in Schedule 1 may be filed in accordance with the requirements of the former right by December 31, 2016.

² The application package for authorisation to release a phytosanitary product may be filed in accordance with the requirements of the old right by 31 December 2016.

This order shall enter into force on 1 ^Er July 2011.