### having regard to the special characteristics of homeopathic veterinary medicinal products , especially the constituents of these products , it is desirable to establish a special , simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications . immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate . the quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules . ### having regard to the special characteristics of homeopathic veterinary medicinal products , especially the constituents of these products , it is desirable to establish a special , simplified registration procedure and to provide specific provisions for labelling for certain homeopathic veterinary medicinal products which are placed on the market without therapeutic indications . immunological homeopathic products cannot follow the simplified registration procedure as immunologicals may initiate a response at a high dilution rate . the quality aspect of a homeopathic medicinal product is independent of its use so no specific provisions should apply with regard to the necessary quality requirements and rules . furthermore , it is desirable to generally allow the use of homeopathic medicinal products designed for human use , including immunological homeopathic products , that have a potency starting from d4 , on all animals , including food producing animals , under certain conditions .


### documentation on the direct or indirect risks to public or animal health of use of the antimicrobial veterinary medicinal product in animals , ### documentation on the direct or indirect risks to public , animal health and the environment of use of the antimicrobial veterinary medicinal product in animals ,


### the scientific name of the stock or stocks followed by the degree of dilution , using the symbols of the european pharmacopoeia or , in the absence thereof , of the pharmacopoeias currently used officially in member states ; ### the scientific name of the stock or stocks followed by the degree of dilution , using the symbols of the european pharmacopoeia or , in the absence thereof , of the pharmacopoeias currently used officially in member states ; if the homeopathic veterinary medicinal product is composed of more than one stock , the scientific names of the stocks may be supplemented by a brand name in the label ;


### target species ; ### target species , and the dosage for each species , where applicable ;


### the competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned and / or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with article 7 . ### the competent authority shall ascertain that the manufacturers of veterinary medicinal products from third countries are able to manufacture the veterinary medicinal product concerned and / or carry out control tests in accordance with the methods described in the documentation submitted in support of the application in accordance with article 7 and that they minimize environmental pollution .


### the product is an antimicrobial veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals or to increase yields from treated animals ; ### the product is a veterinary medicinal product presented for use as performance enhancer in order to promote the growth of treated animals , or to increase yields from treated animals ;


### the commission shall , by means of implementing acts , designate antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 . ### the commission shall , by means of implementing acts and drawing on the scientific recommendations made by the agency , designate further antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans , in accordance with the rules under paragraph 3 . these implementing acts shall be adopted in accordance with the examination procedure referred to in article 145 .


### competent authorities and the agency shall supervise the pharmacovigilance systems of marketing authorisation holders . ### competent authorities and the agency shall supervise the pharmacovigilance systems of marketing authorisation holders . the supervisors shall not have any conflicts of interest with regard to the marketing authorisation holder .


### the agency shall , in collaboration with the member states and the commission , draw up the functional specifications for the pharmacovigilance database . ### the agency shall , in consultation with the member states , the commission , and interested parties , draw up the functional specifications for the pharmacovigilance database . these shall include environmental monitoring data which would report undesirable effects on non - target species in the ecosystem , and extend sources of inputs to the pharmacovigilance system to include observation and monitoring by specialists who are not necessarily veterinarians .


### establishing and maintaining a system which ensures that all adverse events which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the union ; ### establishing and maintaining a system which ensures that all adverse events , including on non - target species and the environment , which are brought to the attention of the marketing authorisation holder are collected and recorded in order to be accessible at least at one site in the union ;


### a manufacturing authorisation may be granted conditionally , subject to a requirement for the applicant to undertake actions or introduce specific procedures within a given time period . the manufacturing authorisation may be suspended if these requirements are not complied with . ### a manufacturing authorisation may be granted conditionally , subject to a requirement for the applicant to undertake actions or introduce specific procedures within a given time period . the manufacturing authorisation may be suspended if these requirements are not complied with . the manufacturing authorisation shall be refused if manufacturing causes unacceptable risks to the environment .


### the agency shall set up a website providing information on the common logo . the agency’s website shall explicitly mention that the websites of member states contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in the member state concerned . ### the agency shall set up a website providing information on the common logo . the agency’s website shall explicitly mention that the websites of member states contain information on persons authorised to offer veterinary medicinal products for sale at a distance to the public by means of information society services in the member state concerned . the agency’s website shall be linked to the web pages of the appropriate member state bodies listing authorised retailers in member states .


### risks to public health if the antimicrobial product is used in accordance with paragraph 1 ; ### risks to public health if the antimicrobial product is used in accordance with paragraph 1 , including the risks involved in using antimicrobials critical to human health in food producing animals .


### competent authorities shall perform controls of manufacturers , importers , marketing authorisation holders , wholesale distributors and suppliers of the veterinary medicinal products regularly , on a risk - basis , in order to verify that the requirements as set out in this regulation are complied with . ### competent authorities shall perform controls of manufacturers , importers , marketing authorisation holders , wholesale distributors and suppliers of the veterinary medicinal products as well as animals and foodstuff regularly , on a risk - basis , in order to verify that the requirements as set out in this regulation are complied with .


### inspection reports shall be uploaded to the appropriate database , with continuous access for all competent authorities . ### final inspection reports shall be uploaded to the appropriate database , with continuous access for all competent authorities , and made public .


### the potential risks relating to the development of antimicrobial resistance . ### the potential risks relating to the development of antimicrobial resistance during production and use .


### this assessment shall normally be conducted in two phases . the first phase of the assessment shall always be performed and the second phase shall be performed if necessary . the details of the assessment shall be provided in accordance with accepted guidance . the assessment shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items : ### this assessment shall normally be conducted in two phases . all available data of sufficient reliability and relevance shall be considered , including information gained during the drug discovery process . the first phase of the assessment shall always be performed and the second phase shall be performed if necessary . the details of the assessment shall be provided in accordance with accepted guidance . the assessment shall indicate the potential exposure of the environment to the product and the level of risk associated with any such exposure taking into account in particular the following items :


### in the second phase , further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted , in accordance with established guidance . the extent of exposure of the product to the environment , and the available information about the physical / chemical , pharmacological and / or toxicological properties of the substance concerned , including metabolites , shall be taken into consideration . ### in the second phase , further specific investigation of the fate and effects of the product on particular ecosystems shall be conducted , in accordance with established guidance , and taking into account the pharmacological effect of the product as well as any relevant side effects . the extent of exposure of the product to the environment , and the available information about the physical / chemical , pharmacological and / or toxicological properties of the substance concerned , including metabolites , shall be taken into consideration .


### the statistics referred to in paragraph 1 shall relate to reference periods of three calendar months and shall be supplied to the commission within two months of the end of the reference period . the first reference period shall be january to march 2020 . ### the statistics referred to in paragraph 1 shall be disaggregated by age and gender of the person concerned , and by unaccompanied minors . they shall relate to reference periods of three calendar months and shall be supplied to the commission within two months of the end of the reference period . the first reference period shall be january to march 2020 .


### the individual assessment shall take place at an appropriate stage of the proceedings and in any event before indictment . ### the individual assessment shall take place at the earliest appropriate stage , and in any event , before indictment .


### in case of deprivation of liberty of a child , member states shall ensure that the child has access to a medical examination with a view , in particular , to assessing the general mental and physical condition of the child with the aim to determine the capacity of the child to face questioning or other investigative or evidence gathering acts or any measures taken or envisaged against the child . ### in case of deprivation of liberty of a child , member states shall ensure that the child has access to a prompt&#160 ; medical examination to evaluate , protect and improve the child ' s physical and mental health and ensure that they receive appropriate treatment .


### member states shall ensure that any deprivation of liberty of children before their conviction is subject to a periodic review by a court . ### every child arrested and deprived of his or her liberty should be brought before a competent court to examine the legality of their deprivation of liberty . member states shall ensure that any deprivation of liberty of children before their conviction is subject to a periodic review , at reasonable intervals of time , by a court . every child deprived of liberty has the right to challenge the legality of the deprivation of liberty before a court or other competent , independent and impartial authority , and to a prompt decision on any such action .


### member states shall ensure that where children were not present at the trial resulting in a decision on their guilt , they shall have the right to a procedure in which they have the right to participate and which allows a fresh determination of the merits of the case , including examination of new evidence , and which may lead to the original decision to be reversed . ### member states shall ensure that where children were not present at the trial resulting in a decision on their guilt , they shall have the right to a retrial in which they have the right to participate and which allows a fresh determination of the merits of the case , including examination of new evidence , and which may lead to the original decision to be reversed .


### member states shall ensure that national law in relation to legal aid guarantees the effective exercise of the right to access to a lawyer as referred to in article 6 . ### member states shall ensure that national law in relation to legal aid guarantees the effective exercise of the right to access to a lawyer as referred to in article 6 by making sure legal aid provided to children is accessible , age - appropriate , effective and responsive to the specific legal and social need of children . children shall receive priority for legal aid and shall always be exempt from a means test .


### council directive 98 / 58 / ec20 lays down general minimum welfare standards for animals bred or kept for farming purposes . it calls on member states to avoid unnecessary pain , suffering or injury of farm animals . if cloning causes unnecessary pain , suffering or injury , member states have to act at national level to avoid it . different national approaches to animal cloning could lead to market distortion . it is thus necessary to ensure that the same conditions apply to all involved in the production and distribution of live animals throughout the union . __________________ 20 council directive 98 / 58 / ec of 20 july 1998 concerning the protection of animals kept for farming purposes . ### the cloning of animals is incompatible with council directive 98 / 58 / ec20 , which lays down general minimum welfare standards for animals bred or kept for farming purposes . directive 98 / 58 / ec calls on member states to avoid unnecessary pain , suffering or injury of farm animals , and , more specifically , states that ' natural or artificial breeding procedures which cause , or are likely to cause , suffering or injury to any of the animals concerned must not be practised ' . different national approaches to animal cloning could lead to market distortion . it is thus necessary to ensure that the same conditions apply to all involved in the production and distribution of animal clones , embryo clones , descendants of animal clones , germinal products of animal clones and of their descendants , and of food from animal clones and their descendants throughout the union . __________________ 20 council directive 98 / 58 / ec of 20 july 1998 concerning the protection of animals kept for farming purposes .


### the european food safety authority has confirmed that surrogate dams used in cloning suffer in particular from placenta dysfunctions contributing to increased levels of miscarriages21 . this contributes , amongst other things , to the low efficiency of the technique , 6 to 15 % for bovine and 6 % for porcine species , and the need to implant embryo clones into several dams to obtain one clone . in addition , clone abnormalities and unusually large offspring result in difficult births and neonatal deaths . __________________ 21 scientific opinion of the scientific committee on food safety , animal health and welfare and environmental impact of animals derived from cloning by somatic cell nucleus transfer and their offspring and products obtained from those animals http : / / www . efsa . europa . eu / en / topics / topic / cloning . htm ? wtrl=01 ### the european food safety authority concluded , in its 2008 opinion on animal cloning20a , that ' the health and welfare of a significant proportion of clones have been found to be adversely affected , often severely and with a fatal outcome ' . more specifically , efsa has confirmed that surrogate dams used in cloning suffer in particular from placenta dysfunctions contributing to increased levels of miscarriages21 . this contributes , amongst other things , to the low efficiency of the technique , 6 to 15 % for bovine and 6 % for porcine species , and the need to implant embryo clones into several dams to obtain one clone . in addition , clone abnormalities and unusually large offspring result in difficult births and neonatal deaths . high mortality rates at all development stages are characteristic of the cloning technique21a . __________________ 20a http : / / www . efsa . europa . eu / en / efsajournal / doc / 767 . pdf 21 scientific opinion of the scientific committee on food safety , animal health and welfare and environmental impact of animals derived from cloning by somatic cell nucleus transfer and their offspring and products obtained from those animals http : / / www . efsa . europa . eu / en / topics / topic / cloning . htm ? wtrl=01 21a http : / / www . efsa . europa . eu / en / efsajournal / doc / 2794 . pdf


### the specific programme ' s actions should be used to address market failures or sub - optimal investment situations , in a proportionate manner , without duplicating or crowding out private financing and have a clear european added value . ### the specific programme ' s actions should be used to address market failures or sub - optimal investment situations , in a proportionate manner , without investing again in projects that are not innovative anymore or are already applicable , and without duplicating or crowding out private financing and have a clear european added value .


### increasing collaboration across sectors and disciplines ; ### increasing collaboration across sectors and research disciplines , including social sciences and humanities ;


### involving citizens and end - users in co - design and co - creation processes ; ### involving societal actors , including citizens , civil society and end - users organisations in r&i agenda - setting , including co - design and co - creation processes ;


### an assessment of the union legal framework for the type - approval of motor vehicles and their trailers , and of systems , components and separate technical units intended for such vehicles , carried out in 201311 , showed that the framework established by directive 2007 / 46 / ec is appropriate for achieving the main goals of harmonisation , effective operation of the internal market and fair competition , and therefore should continue to apply . __________________ 11 commission staff working document ‘ fitness check of the eu legal framework for the type - approval of motor vehicles’ 466 final ) . ### an assessment of the union legal framework for the type - approval of motor vehicles and their trailers , and of systems , components and separate technical units intended for such vehicles , carried out in 201311 , showed that the framework established by directive 2007 / 46 / ec is appropriate for achieving the main goals of harmonisation , effective operation of the internal market and fair competition , and therefore should continue to apply . fair competition necessitates , inter alia , better harmonisation of quality standards of conformity of production , high uniform levels of technological testing , similar fees , and respect of the principles of independence and transparency throughout the verification chain . __________________ 11 commission staff working document ‘ fitness check of the eu legal framework for the type - approval of motor vehicles’ 466 final ) .


### this regulation sets out the harmonised rules and principles for the type - approval of motor vehicles and their trailers , and of systems , components and separate technical units intended for such vehicles , and the individual vehicle approval , with a view to ensuring the proper functioning of the internal market for the benefit of businesses and consumers and to offer a high level of safety and protection of health and the environment . ### this regulation sets out the harmonised rules and principles for the type - approval of motor vehicles and their trailers , and of systems , components and separate technical units intended for such vehicles , and the individual vehicle approval , with a view to ensuring the consistent application of high - quality standards for verifying conformity of production , enabling the internal market to function properly for the benefit of businesses and consumers and offering a high level of safety and protection of health and the environment .


### an effective implementation of the type - approval requirements should be ensured by enhancing the provisions on conformity of production by , inter alia , providing for mandatory periodic audits of the conformity control methods and the continued conformity of the products concerned and by reinforcing the requirements relating to the competence , obligations and performance of the technical services that carry out tests for whole - vehicle type - approval under the responsibility of type - approval authorities . the proper functioning of technical services is crucial for ensuring a high level of safety and environmental protection and citizens’ confidence in the system . the criteria for designation of technical services provided by directive 2007 / 46 / ec should be laid down in greater detail in order to assure their consistent application . the assessment methods of technical services in the member states have a tendency to progressively differ due to the increased complexity of their work . therefore , it is necessary to provide for procedural obligations that ensure an information exchange and monitoring of member states’ practices for the assessment , designation , notification and monitoring of their technical services . those procedural obligations should remove any existing discrepancies in the methods used and in the interpretation of the criteria for the designation of technical services . ### an effective implementation of the type - approval requirements should be ensured by enhancing the provisions on conformity of production by giving better access to information , by firmly framing optimisation techniques during lab testing , by paying particular attention to the risk of illegal defeat devices the use of which is forbidden by regulation no 715 / 2007 of the european parliament and of the council1 , by providing for mandatory periodic audits of the conformity control methods and the continued conformity of the products concerned and by reinforcing the requirements relating to the competence , obligations and performance of the technical services that carry out tests for whole - vehicle type - approval under the responsibility of type - approval authorities . the proper functioning of technical services is crucial for ensuring a high level of safety and environmental protection and citizens’ confidence in the system . the criteria for designation of technical services provided by directive 2007 / 46 / ec should be laid down in greater detail in order to assure their consistent application . the assessment methods of technical services in the member states have a tendency to progressively differ due to the increased complexity of their work . therefore , it is necessary to provide for procedural obligations that ensure an information exchange and monitoring of member states’ practices for the assessment , designation , notification and monitoring of their technical services . those procedural obligations should remove any existing discrepancies in the methods used and in the interpretation of the criteria for the designation of technical services . __________________________________ 1 regulation no 715 / 2007 of the european parliament and of the council of 20 june 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles and on access to vehicle repair and maintenance information .


### market surveillance authorities shall perform regular checks to verify compliance of vehicles , systems , components and separate technical units with the requirements set out in this regulation as well as with the correctness of the type approvals . those checks shall be performed on an adequate scale , by means of documentary checks and real - drive and laboratory tests on the basis of statistically relevant samples . when doing so , market surveillance authorities shall take account of established principles of risk assessment , complaints and other information . ### market surveillance authorities shall perform regular checks to verify compliance of vehicles , systems , components and separate technical units with the requirements set out in this regulation as well as with the correctness of the type approvals , and shall pay equal attention to safety and to environment standards . those checks shall be performed by means of documentary checks and real - drive and laboratory tests on the basis of a statistically significant sample . when doing so , market surveillance authorities shall take account of established principles of risk assessment , third - party test results , complaints and other information coming from their own country as well as information provided by other member states . in the case of vehicles , market surveillance authorities shall aim to cover 20% of the new models placed on the union market each year to verify whether the vehicles concerned comply with the union safety and environmental legislation . when technical services are designated for the purposes of this article , market surveillance authorities shall ensure that a different technical service is used from that performing tests relating to the original type - approval .


### market surveillance authorities shall require economic operators to make the documentation and information available as they consider necessary for the purpose of carrying out their activities . ### market surveillance authorities shall require economic operators to make the documentation and information available without delay as they consider necessary for the purpose of carrying out their activities .


### the commission shall organise and carry out , or require to be carried out , on an adequate scale , tests and inspections of vehicles , systems , components and separate technical units already made available on the market , with a view to verifying that those vehicles , systems , components and separate technical units conform to the type approvals and to applicable legislation as well as to ensure the correctness of the type approvals . ### the european authority shall organise and carry out , or require to be carried out , in accordance with the objectives laid down in article 8 , tests and inspections of vehicles , systems , components and separate technical units already made available on the market , with a view to verifying that those vehicles , systems , components and separate technical units conform to the type approvals and to applicable legislation as well as to ensure the correctness of the type approvals . those tests and inspections shall not be performed by the same technical service as that used to perform the original type - approval tests .


### vehicle manufacturers shall make public data which are needed for the purpose of compliance verification testing by third parties . the commission shall adopt implementing acts in order to define the data to be made public and the conditions for such publication , subject to the protection of commercial secrets and the preservation of personal data pursuant to union and national legislation . those implementing acts shall be adopted in accordance with the examination procedure referred to in article 87 . ### vehicle manufacturers shall make public data which are needed for the purpose of compliance verification testing by third parties . the european authority shall list the data that are to be made available to be public and the conditions for such publication , subject to the protection of commercial secrets and the preservation of personal data pursuant to union and national legislation . those lists shall be adopted in accordance with the examination procedure referred to in article 87 .


### where the commission establishes that the vehicles tested or inspected do not comply with the type - approval requirements laid down in this regulation or any of the regulatory acts listed in annex iv or that the type approval has been granted on the basis of incorrect data , it shall require in accordance with article 54 without delay the economic operator concerned to take all appropriate corrective measures to bring the vehicles in compliance with those requirements , or it shall take restrictive measures , either by requiring the economic operator to withdraw the vehicles concerned from the market , or to recall them within a reasonable period of time , depending on the seriousness of the established non - compliance . ### where the european authority establishes that the vehicles tested or inspected do not comply with the type - approval requirements laid down in this regulation or any of the regulatory acts listed in annex iv or that the type approval has been granted on the basis of incorrect data , it shall be empowered to take union - wide remedial action such as ordering union recalls of the vehicles concerned , or it shall require in accordance with article 54 without delay the national authorities and economic operators concerned to take all appropriate corrective measures to bring the vehicles in compliance with those requirements , or it shall take restrictive measures , either by requiring the economic operator to withdraw the vehicles concerned from the market , or to recall them within a reasonable period of time , depending on the seriousness of the established non - compliance . non - compliance with environment standards shall be treated on an equal footing with safety issues .


### the distributor who considers that a vehicle , system , component or separate technical unit that he has made available on the market is not in conformity with this regulation , shall inform the manufacturer or the importer to ensure that the appropriate measures necessary to bring that vehicle , system , component or separate technical unit into conformity , to withdraw it from the market or to recall it , as appropriate , are taken in accordance with article 12 or article 15 . ### where a distributor considers that a vehicle , system , component or separate technical unit that it has made available on the market is not in conformity with this regulation , it shall inform the manufacturer , the importer and the approval and market surveillance authorities to ensure that the appropriate measures necessary to bring that vehicle , system , component or separate technical unit into conformity , to withdraw it from the market or to recall it , as appropriate , are taken in accordance with article 12 or article 15 .


### the approval authority and technical services shall have access to the software and algorithms of the vehicle . ### the approval authority and technical services shall have access to safety and emissions - related software and hardware as well as algorithms of the vehicle . manufacturers shall communicate to the approval authorities and the technical service , in a standardised form , the safety and emissions - related software at the time of the application in order to detect subsequent unlawful changes to the software .


### member states shall establish a national fee structure to cover the costs for their type - approvals and market surveillance activities as well as for the type - approval testing and conformity of production testing and inspections carried out by the technical services they have designated . ### the european authority , together with the forum , shall establish a union - wide fee structure to cover the costs for its type - approval and market surveillance activities , in order to have a consistent fee structure across the union adapted to the type - approval testing and conformity of production testing and inspections carried out by the technical services it has designated .


### those national fees shall be levied on the manufacturers who have applied for type - approval in the member state concerned . fees shall not be levied directly by . technical services ### the national fees referred to in paragraph 1 a shall be levied on the manufacturers who have applied for type - approval in the member state concerned . fees shall also cover market surveillance activities pursuant to article 8 .


### market surveillance authorities of one member state that have taken action pursuant to article 20 of regulation no 765 / 2008 and article 8 of this regulation , or that have sufficient reason to believe that a vehicle , system , component or separate technical unit covered by this regulation presents a serious risk to the health or safety of persons or to other aspects of the protection of public interests covered by this regulation , shall inform without delay the approval authority that granted the approval about its findings . ### market surveillance authorities of one member state that have taken action pursuant to article 20 of regulation no 765 / 2008 and article 8 of this regulation , or that have sufficient reason to believe that a vehicle , system , component or separate technical unit covered by this regulation presents a risk to the environment , health or safety of persons or to other aspects of the protection of public interests covered by this regulation , shall inform without delay the approval authority that granted the approval about its findings .


### the approval authority referred to in paragraph 1 shall carry out an evaluation in relation to the vehicle , system , component or separate technical unit concerned covering all the requirements laid down in this regulation . the relevant economic operators shall cooperate fully with the approval and market surveillance authorities . ### the approval authority referred to in paragraph 1 shall carry out an evaluation in relation to the vehicle , system , component or separate technical unit concerned covering all the requirements laid down in this regulation . the relevant economic operators shall cooperate fully with the approval and market surveillance authorities and shall give them access without delay to any information required .


### where , having performed an evaluation under article 49 , a member state finds that vehicles , systems , components or separate technical units , although they comply with the applicable requirements or are properly marked , present a serious risk to safety or may seriously harm the environment or public health , it shall require the relevant economic operator to take all appropriate corrective measures to ensure that the vehicle , system , component or separate technical unit concerned , when placed on the market , registered or entered into service , no longer presents that risk , or it shall take restrictive measures to withdraw the vehicle , system , component or separate technical unit from the market or to recall it within a reasonable period , depending on the nature of the risk . ### where , having performed an evaluation under article 49 , a member state finds that vehicles , systems , components or separate technical units , although they comply with the applicable requirements or are properly marked , present a serious risk to safety , the environment or health , it shall require the relevant economic operator to take all appropriate corrective measures to ensure that the vehicle , system , component or separate technical unit concerned , when placed on the market , registered or entered into service , no longer presents that risk , or it shall take restrictive measures to withdraw the vehicle , system , component or separate technical unit from the market or to recall it within a reasonable period , depending on the nature of the risk .


### category b : supervision of the tests referred to in this regulation and in the acts listed in annex iv , where those tests are performed in the manufacturer’s facilities or in the facilities of a third party ; ### category b : supervision before and during the tests referred to in this regulation and in the acts listed in annex iv , where those tests are performed in the manufacturer’s facilities or in the facilities of a third party ; this category of tests is subject to a derogation on economic grounds . category b tests shall not be permitted in the case of whole - vehicle type - approvals ;


### given their importance , the plan provided for in this regulation should cover recreational fisheries catching western mediterranean demersal stocks . where such fisheries have a significant impact on stocks , the multi - annual plan provided for by this regulation should provide for the possibility of specific management measures . ### as recreational fisheries can have a significant impact on fish resources , the multiannual plan should provide a framework to ensure that they are conducted in a manner compatible with the objectives of the plan . member states should collect catch data of recreational fisheries . where such fisheries have a significant impact on the resources , the plan should foresee the possibility to decide on specific management measures .


### it is appropriate to establish the target fishing mortality that corresponds to the objective of reaching and maintaining msy as ranges of values which are consistent with achieving msy . those ranges , based on best available scientific advice , are necessary to provide flexibility to take account of developments in the scientific advice , contribute to the implementation of the landing obligation and accommodate mixed fisheries . based on this plan , they are derived to deliver no more than 5 % reduction in the long - term yield as compared with msy . in addition , the upper limit of the fmsy range is capped with the aim that the probability of the stock falling below the biomass limit reference point is no more than 5 % . ### in order to achieve the objectives expressed in article 2 of regulation no 1380 / 2013 , it is appropriate to establish the target fishing mortality that corresponds to the objective of reaching and maintaining not exceeding msy exploitation rate as ranges of values which are consistent with achieving msy . this rate shall be achieved as soon as possible and , on a progressive , incremental basis at the latest by 2020 for all stocks to which this regulation applies , and maintained thereafter . those ranges , based on best available scientific advice , are necessary to provide flexibility to take account of developments in the scientific advice , contribute to the implementation of the landing obligation and accommodate mixed fisheries . based on this plan , they are derived to deliver no more than 5 % reduction in the long - term yield as compared with msy . in addition , the upper limit of the fmsy range is capped with the aim that the probability of the stock falling below the biomass limit reference point is no more than 5 % .


### the plan shall implement the ecosystem - based approach to fisheries management in order to ensure that negative impacts of fishing activities on the marine ecosystem are minimised . it shall be coherent with union environmental legislation , in particular with the objective of achieving good environmental status by 2020 as set out in article 1 of directive 2008 / 56 / ec and the objectives set out in articles 4 and 5 of directive 2009 / 147 / ec and articles 6 and 12 of council directive 92 / 43 / eec . ### the plan shall implement the ecosystem - based approach to fisheries management in order to ensure that negative impacts of fishing activities on the marine ecosystem , and on vulnerable habitats and protected species , including marine mammals , reptiles and seabirds , are minimised . it shall be coherent with union environmental legislation , in particular with the objective of achieving good environmental status by 2020 as set out in article 1 of directive 2008 / 56 / ec and the objectives set out in articles 4 and 5 of directive 2009 / 147 / ec and articles 6 and 12 of council directive 92 / 43 / eec .


### contribute to the fulfilment of other relevant descriptors contained in annex i to directive 2008 / 56 / ec in proportion to the role played by fisheries in their fulfilment . ### contribute to the fulfilment of other relevant descriptors contained in annex i to directive 2008 / 56 / ec in proportion to the role played by fisheries in their fulfilment and ensure that negative impacts of fishing on the marine environment are minimised , in particular regarding vulnerable habitats and protected species , including marine mammals , reptiles and seabirds .


### where the scientific advice shows that the spawning biomass of any of the stocks concerned is below the precautionary reference point , remedial measures shall be adopted to ensure the rapid return of the stocks concerned to levels above those capable of producing msy . in particular , by way of derogation from article 4 and , fishing opportunities shall be set at levels consistent with a fishing mortality that is reduced within the range of fmsy for the most vulnerable stock , taking into account the decrease in biomass . ### where the scientific advice shows that the spawning biomass of any of the stocks concerned is below the precautionary reference point , remedial measures shall be adopted to ensure the rapid return of the stocks concerned to levels above those capable of producing msy . in particular , by way of derogation from article 4 and , fishing opportunities shall be set at levels not exceeding the exploitation rate consistent with maximum sustainable yield and consistent with a fishing mortality that is reduced within the range of fmsy for the most vulnerable stock , taking into account the decrease in biomass .


### within two years of the adoption of this regulation and on the basis of the scientific advice , the member states concerned shall establish other closure areas where there is evidence of a high concentration of juvenile fish and of spawning grounds of demersal stocks , in particular for the stocks concerned . ### within two years of the adoption of this regulation and on the basis of the scientific advice , the member states concerned shall establish other closure areas where there is evidence of a high heavy concentrations of juvenile fish , fish below minimum conservation reference size and of spawning grounds of demersal stocks , in particular for the stocks


### specifying the characteristics of fishing gear , in particular mesh size , hook size , number of hooks , construction of the gear , twine thickness , size of the gear or use of additional devices to improve selectivity ; ### specifying the characteristics of fishing gear , in particular mesh size , hook size , number of hooks , construction of the gear , twine thickness , size of the gear or use of additional devices to improve selectivity , to reduce unwanted catches and to minimise the negative impact of fishing operations on the ecosystem ;


### limiting the use of fishing gear , in particular immersion time and depth of gear deployment , so as to improve selectivity ; ### limiting the use of fishing gear , in particular immersion time and depth of gear deployment , or application of technical measures , so as to improve selectivity , to reduce unwanted catches and to minimise the negative impact of fishing operations on the ecosystem ;


### five years after the date of entry into force of this regulation and every five years thereafter , the commission shall report to the european parliament and to the council on the results and the impact of the plan on the stocks to which this regulation applies and on the fisheries exploiting those stocks , in particular as regards the achievement of the objectives set out in article 3 . ### two years after the date of entry into force of this regulation and every three years thereafter , the commission shall report to the european parliament and to the council on the results and the impact of the plan on the stocks to which this regulation applies and on the fisheries exploiting those stocks , in particular as regards the achievement of the objectives set out in article 3 .


### the commission shall be empowered to adopt delegated acts in accordance with article 210 concerning detailed rules on external action procurement . ### the commission shall be empowered to adopt delegated acts in accordance with article 210 concerning detailed rules on external action procurement . &#160 ; these rules shall include specific provisions on procurement related to civilian missions under the common security and defence policy in order to guarantee the rapid and flexible conduct of operations , establishing , in particular , adapted fast - track procedures to be applied to all civilian csdp missions .


### the commission should carry out an evaluation of this regulation . pursuant to paragraph 22 of the interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 201643 , that evaluation should be based on the five criteria of effectiveness , efficiency , relevance , coherence and added value and should provide the basis for impact assessments of possible further measures . the evaluation should take into account exports to outside the union and the ability of generics and especially biosimilars to enter markets in the union as soon as possible after a certificate lapses . in particular , this evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for generic and biosimilar firms in the union and a swifter entry of generic and especially biosimilar medicines onto the market after a certificate lapses . it should also study the impact of the exception on research and production of innovative medicines by holders of certificates in the union and consider the balance between the different interests at stake , including those of public health . _________________ 43 oj l 123 , 12 . 5 . 2016 , p . 1 . ### the commission should carry out an evaluation of this regulation . pursuant to paragraph 22 of the interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 201643 , that evaluation should be based on the five criteria of effectiveness , efficiency , relevance , coherence and added value and should provide the basis for impact assessments of possible further measures . the evaluation should take into account exports to outside the union and the ability of generics and especially biosimilars to enter markets in the union on day - 1 after a certificate lapses . in particular , this evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for generic and biosimilar firms in the union and a swifter entry of generic and especially biosimilar medicines onto the market after a certificate lapses . it should also study the impact of the exception on research and production of innovative medicines by holders of certificates in the union and consider the balance between the different interests at stake , including access to medicines and above all those of public health . _________________ 43 oj l 123 , 12 . 5 . 2016 , p . 1 .


### the commission should carry out an evaluation of this regulation . pursuant to paragraph 22 of the interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 201643 , that evaluation should be based on the five criteria of effectiveness , efficiency , relevance , coherence and added value and should provide the basis for impact assessments of possible further measures . the evaluation should take into account exports to outside the union and the ability of generics and especially biosimilars to enter markets in the union as soon as possible after a certificate lapses . in particular , this evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for generic and biosimilar firms in the union and a swifter entry of generic and especially biosimilar medicines onto the market after a certificate lapses . it should also study the impact of the exception on research and production of innovative medicines by holders of certificates in the union and consider the balance between the different interests at stake , including those of public health . _________________ 43 oj l 123 , 12 . 5 . 2016 , p . 1 . ### the commission should carry out an evaluation of this regulation . the merits of the present regulation deserve a thorough debate ; the impact of the patent system , and of the spc protection in particular , on generic competition , on healthcare budgets and on the access to medicines in europe should be carefully assessed through a continuous evaluation of the spc system . given the paramount importance of access to and affordability of medicinal products for public health and public expenditure , a frequent evaluation cycle is justified . pursuant to paragraph 22 of the interinstitutional agreement between the european parliament , the council of the european union and the european commission on better law - making of 13 april 201643 , that evaluation should be based on the five criteria of effectiveness , efficiency , relevance , coherence and added value and should provide the basis for impact assessments of possible further measures . the evaluation should take into account exports to outside the union and the ability of generics and especially biosimilars to enter markets in the union as soon as possible after a certificate lapses . in particular , this evaluation should review the effectiveness of the exception in the light of the aim to restore a global level playing field for generic and biosimilar firms in the union and a swifter entry of generic and especially biosimilar medicines onto the market after a certificate lapses . it should also study the impact of the exception on research and production of innovative medicines by holders of certificates in the union and consider the balance between the different interests at stake , including those of public health . _________________ 43 oj l 123 , 12 . 5 . 2016 , p . 1 .


### no later than five years after the date referred to in article 4 , and every five years thereafter , the commission shall carry out an evaluation of articles 4 to and 11 and present a report on the main findings to the european parliament , the council and the european economic and social committee . ; ### every year , the commission shall carry out an evaluation of the impact of patent protection , and in particular the spc system including the spc manufacturing waiver once introduced , on access to medicines and public health , articles 4 to and 11 and present a report on the main findings to the european parliament , the council and the european economic and social committee ;


### the european parliament in its resolution on ‘ effective labour inspections as a strategy to improve working conditions in europe’ welcomed the commission’s initiative to create a european platform and called for enhanced cooperation at eu level to fight undeclared work27 . __________________ 27 european parliament resolution of 14 january 2014 on effective labour inspections as a strategy to improve working conditions in europe http : / / www . europarl . europa . eu / oeil / popups / ficheprocedure . do ? lang=en&reference=2013 / 2112 ### the european parliament in its resolution on ‘ effective labour inspections as a strategy to improve working conditions in europe’ welcomed the commission’s initiative to create a european platform and called for stronger enhanced cooperation at union level in the prevention and deterrence of undeclared work27 __________________ 27 european parliament resolution of 14 january 2014 on effective labour inspections as a strategy to improve working conditions in europe http : / / www . europarl . europa . eu / oeil / popups / ficheprocedure . do ? lang=en&reference=2013 / 2112


### the abuse of the status of self - employed , either at national level or in cross - border situations , is frequently associated with undeclared work . bogus self - employment occurs when a person is declared as self - employed while fulfilling the conditions characteristic of an employment relationship , in order to avoid certain legal or fiscal obligations . bogus self - employment is , therefore , falsely declared work and should come under the scope of the platform . ### as a core part of undeclared work constitutes of work falsely declared , the platform should deal with this practice . falsely declared work refers to paid activities that could be lawful as regards their nature , but are not declared correctly to public authorities . a specific form of falsely declared work is the abuse of the status of self - employed , either at national level or in cross - border situations . bogus self - employment occurs when a person is declared as self - employed while fulfilling the conditions characteristic of an employment relationship , in order to avoid certain legal or fiscal obligations . bogus self - employment is , therefore , falsely declared work and should come under the scope of the platform . the increasing phenomenon of fraudulent non - declaration of workers in cross - border service provision needs to be tackled in the platform and main fraud risks identified .


### eu level cooperation remains far from comprehensive , both in terms of the member states involved and the issues covered . there is a no formal mechanism in place for cross - border cooperation between member states’ relevant authorities to address issues related to undeclared work . ### close and effective cooperation at union level remains far from comprehensive , both in terms of the member states involved and the issues covered . there is a no formal mechanism in place for cross - border cooperation between member states’ relevant authorities to address issues related to undeclared work . member states therefore need to increase resources for labour inspections to improve cross - border enforcement .


### the platform should make use of all relevant sources of information , in particular studies , bilateral agreements concluded between member states and multilateral cooperation projects and create synergies between existing eu level instruments and structures to maximise the deterrent or preventive effect of these measures . the operational coordination of actions of the member states could take the form of joint trainings , peer reviews and solutions for data sharing . european campaigns or common strategies could increase the awareness of undeclared work . ### the platform should make use of all relevant sources of information , in particular studies , bilateral agreements concluded between member states and multilateral cooperation projects and create synergies between existing instruments and structures at union level to maximise the deterrent or preventive effect of these measures . in order to achieve this , the platform should involve non - state actors as important sources of information . the actions of the platform could take the form of a framework for joint trainings , peer reviews and solutions for data sharing . european campaigns or common strategies could increase the awareness of undeclared work . the platform should strengthen close and effective cooperation between the member states by promoting and facilitating innovative approaches of cross - border cooperation and enforcement , as well as evaluating their experiences of such cooperation to draw conclusions for future policy action .


### the platform and its tasks should be funded through the progress axis of the programme for employment and social innovation within the appropriations set by the budgetary authority . ### the platform and its activities should initially be funded through the progress axis of the programme for employment and social innovation within the appropriations set by the budgetary authority but opts for a stable autonomous financing from the eu budget to allow for reliable long - term planning .


### the following may attend the meetings of the platform as observers under the conditions set in its rules of procedure : ### the following stakeholders should attend the meetings of the platform under the conditions set in its rules of procedure :


### the platform , as set out in article 1 , shall contribute to better enforcement of eu and national law , to the reduction of undeclared work and the emergence of formal jobs , hence avoiding the deterioration of quality of work , and to promote integration in the labour market and social inclusion by : ### as a first step , the platform , as set out in article 1 , shall contribute to enforcement and improvement of eu and national law , to the reduction of undeclared work and the emergence of formal jobs , hence avoiding the deterioration of rights at work and of quality of work , to respect for legal standards and to promoting integration in the labour market and social inclusion , including better enforcement of law within those fields , by :


### adopt non - binding guidelines for inspectors , handbooks of good practice and common principles of inspections to tackle undeclared work , ### adopt guidelines for inspectors , handbooks of good practice and common principles of inspections to tackle and resolve undeclared work .


### for the execution of its mission , the platform shall adopt by majority decision : ### for the execution of its mission , the platform and all its composing bodies shall adopt its decisions by simple majority . the platform shall decide on :


### the rules of procedure , containing , inter alia , the decision - making arrangements of the platform , ### the specific rules of procedure , containing , inter alia , the decision - making arrangements of the platform and its working groups ,


### the programme ' s general objective is to deliver scientific , economic and societal impact from the union ' s investments in research and innovation so as to strengthen the scientific and technological bases of the union and foster its competitiveness , including in its industry , deliver on the union strategic priorities , and contribute to tackling global challenges , including the sustainable development goals . ### the programme ' s general objective is to contribute to tackle global challenges identified by the sustainable development goals by investing in research and innovation so as to strengthen the scientific and technological bases of the union .


### to strengthen the impact of research and innovation in developing , supporting and implementing union policies , and support the uptake of innovative solutions in industry and society to address global challenges ; ### to strengthen the impact of research and innovation in developing , supporting and implementing union policies , and support the uptake of research outcomes and innovative solutions in industry and society to address global challenges ;


### to foster all forms of innovation , including breakthrough innovation , and strengthen market deployment of innovative solutions ; ### to foster all forms of innovation conducive to the achievement of the sustainable development goals , including breakthrough innovation , and strengthen market deployment of such innovative solutions ;


### in order to make the european citizens’ initiative more accessible , and taking into account that the procedures and conditions required for the european citizens’ initiative should be clear , simple , user - friendly and proportionate , it is appropriate to partially register an initiative in cases where only part or parts of the initiative meet the requirements for registration under this regulation . initiatives should be partially registered where a substantial part of the initiative , including its main objectives , does not manifestly fall outside the framework of the commission’s powers to submit a proposal for a legal act of the union for the purpose of implementing the treaties and all the other registration requirements are met . clarity and transparency should be ensured as regards the scope of the partial registration and potential signatories should be informed of the scope of the registration and of the fact that statements of support are collected only in relation to the scope of the registration of the initiative . ### in order to make the european citizens’ initiative more accessible , and taking into account that the procedures and conditions required for the european citizens’ initiative should be clear , simple , user - friendly and proportionate , it is appropriate to partially register an initiative in cases where only part or parts of the initiative meet the requirements for registration under this regulation . initiatives should be partially registered where a substantial part of the initiative , including its main objectives , does not manifestly fall outside the framework of the commission’s powers to submit a proposal for a legal act of the union for the purpose of implementing the treaties and all the other registration requirements are met . clarity and transparency must be ensured as regards the scope of the partial registration and potential signatories should be informed of the scope of the registration and of the fact that statements of support are collected only in relation to the scope of the registration of the initiative .


### each member state shall establish one or more contact points to provide information and assistance to groups of organisers in setting up a european citizens’ initiative . ### each member state shall establish one or more contact points to provide information and assistance to groups of organisers in setting up a european citizens’ initiative and provide information in the official and co - official languages of the member state .


### ‘ positive carbon impact benchmark’ means a benchmark where the underlying assets , for the purposes of point 1 of this paragraph , are selected on the basis that their carbon emissions savings exceed the asset ' s carbon footprint and which is constructed in accordance with the standards laid down in the delegated acts referred to in article 19a . ; ### ‘ climate transition benchmark’ means a benchmark that meets all of the following requirements : the underlying assets selected for the benchmark are on a trajectory to become aligned with the paris agreement to limit global warming to 1 . 5&#176 ; c ; the asset issuers’ emissions reduction plans must include measurable targets and time - based targets that are robust and evidence - based ; the companies responsible for the underlying assets have in place emissions reduction plans that are detailed and disaggregated down to the level of individual physical assets to enable a judgment to be made about it ; the asset issuers must report annually on the progress made towards these targets ; the benchmark is constructed in accordance with the standards laid down in the delegated acts referred to in article 19a . ” ;


### the commission shall be empowered to adopt delegated acts in accordance with article 49 to specify further the minimum content of the explanation referred to in point of paragraph 1 . ; ### the commission shall be empowered to adopt delegated acts in accordance with article 49 to specify further the minimum content of the explanation referred to in points and of paragraph 1 as well as the standard format to be used . ;


### for each requirement in paragraph 2 , a benchmark statement shall contain an explanation of how environmental , social and governance factors are reflected for each benchmark or family of benchmarks provided and published which pursue or take into account esg objectives . ### for each requirement in paragraph 2 , a benchmark statement shall contain an explanation of how environmental , social and governance factors are reflected in each benchmark or family of benchmarks provided , including their degree of alignment with the goals of the paris climate agreement .


### methodology for low carbon benchmarks ### disclosures for low carbon benchmarks


### administrators of low - carbon and positive carbon impact benchmarks shall regularly examine their methodologies to ensure that they reliably reflect the relevant low - carbon or positive carbon objectives and shall have a process in place for taking the views of relevant users into account . ” . ### administrators of low - carbon and climate transition benchmarks shall review their methodologies at least annually to ensure that they reliably reflect the relevant low - carbon or climate transition objectives and shall have a process in place for taking the views of all relevant users into account . ” .


### contaminants in ce marked fertilising products , such as cadmium , can potentially pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain . their content should therefore be limited in such products . furthermore , impurities in ce marked fertilising products derived from bio - waste , in particular polymers but also metal and glass , should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio - waste before processing . ### contaminants in ce marked fertilising products , such as cadmium , can potentially pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain . impurities should therefore be strictly limited in such products , and information on the presence of impurities in fertiliser should be clearly displayed on the packaging . furthermore , impurities in ce marked fertilising products derived from bio - waste , in particular polymers but also metal and glass , should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio - waste before processing .


### for certain recovered wastes within the meaning of directive 2008 / 98 / ec of the european parliament and of the council20 , a market demand for their use as fertilising products has been identified . furthermore , certain requirements are necessary for the waste used as input in the recovery operation and for the treatment processes and techniques , as well as for fertilising products resulting from the recovery operation , in order to ensure that the use of those products does not lead to overall adverse environmental or human health impacts . for ce marked fertilising products , those requirements should be laid down in this regulation . therefore , as of the moment of compliance with all the requirements of this regulation , such products should cease to be regarded as waste within the meaning of directive 2008 / 98 / ec . __________________ 20 directive 2008 / 98 / ec of the european parliament and of the council on waste and repealing certain directives . ### for certain recovered wastes within the meaning of directive 2008 / 98 / ec of the european parliament and of the council20 , a market demand for their use as fertilising products has been identified . furthermore , certain requirements are necessary for the waste used as input in the recovery operation and for the treatment processes and techniques , as well as for fertilising products resulting from the recovery operation , in order to ensure that the use of those products does not lead to overall adverse environmental or human health impacts , and clear information about potential adverse effects should be provided . for ce marked fertilising products , those requirements should be laid down in this regulation . therefore , as of the moment of compliance with all the requirements of this regulation , such products should cease to be regarded as waste within the meaning of directive 2008 / 98 / ec . __________________ 20 directive 2008 / 98 / ec of the european parliament and of the council on waste and repealing certain directives .


### certain substances and mixtures , commonly referred to as agronomic additives , improve the nutrient release pattern of a nutrient in a fertiliser . substances and mixtures made available on the market with the intention of them being added to ce marked fertilising products for that purpose should fulfil certain efficacy criteria at the responsibility of the manufacturer of those substances or mixtures , and should therefore as such be considered as ce marked fertilising products under this regulation . furthermore , ce marked fertilising products containing such substances or mixtures should be subject to certain efficacy and safety criteria . such substances and mixtures should therefore also be regulated as component materials for ce marked fertilising products . ### certain substances and mixtures , commonly referred to as agronomic additives , improve the nutrient release pattern of a nutrient in a fertiliser . substances and mixtures made available on the market with the intention of them being added to ce marked fertilising products for that purpose should fulfil certain efficacy , safety and environmental criteria at the responsibility of the manufacturer of those substances or mixtures , and should therefore as such be considered as ce marked fertilising products under this regulation . furthermore , ce marked fertilising products containing such substances or mixtures should be subject to certain efficacy , safety and environmental criteria . such substances and mixtures should therefore also be regulated as component materials for ce marked fertilising products .


### this regulation should not prevent the application of existing union legislation relating to aspects of protection of health , safety and the environment not covered by this regulation . this regulation should therefore apply without prejudice to council directive 86 / 278 / eec22 , council directive 89 / 391 / eec23 , regulation no 1907 / 2006 of the european parliament and of the council24 , regulation no 1272 / 2008 of the european parliament and of the council25 , commission regulation no 1881 / 200626 , council directive 2000 / 29 / ec27 , regulation no 98 / 2013 of the european parliament and of the council28 , and regulation no 1143 / 2014 of the european parliament and of the council29 . __________________ 22 council directive 86 / 278 / eec of 12 june 1986 on the protection of the environment , and in particular of the soil , when sewage sludge is used in agriculture . 23 council directive 89 / 391 / eec of 12 june 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work . 24 regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals . 25 regulation no 1272 / 2008 of the european parliament and of the council of 16 december 2008 on classification , labelling and packaging of substances and mixtures . 26 commission regulation no 1881 / 2006 of 19 december 2006 setting maximum levels for certain contaminants in foodstuffs . 27 council directive 2000 / 29 / ec of 8 may 2000 on protective measures against the introduction into the community of organisms harmful to plants or plant products and against their spread within the community . 28 regulation no 98 / 2013 of the european parliament and of the council of 15 january 2013 on the marketing and use of explosives precursors . 29 regulation no 1143 / 2014 of the european parliament and of the council of 22 october 2014 on the prevention and management of the introduction and spread of invasive alien species . ### this regulation should not prevent the application of existing union legislation relating to aspects of protection of health , safety and the environment not covered by this regulation . this regulation should therefore apply without prejudice to council directive 86 / 278 / eec22 , council directive 91 / 676 / eec22a , council directive 2000 / 60 / ec 22b , council directive 89 / 391 / eec23 , regulation no 1907 / 2006 of the european parliament and of the council24 , regulation no 1272 / 2008 of the european parliament and of the council25 , commission regulation no 1881 / 200626 , council directive 2000 / 29 / ec27 , regulation no 98 / 2013 of the european parliament and of the council28 , regulation no 1143 / 2014 of the european parliament and of the council29 and council regulation no 834 / 2007 29a . __________________ 22 council directive 86 / 278 / eec of 12 june 1986 on the protection of the environment , and in particular of the soil , when sewage sludge is used in agriculture . 22a council directive 91 / 676 / eec of 12 december 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources . 22b directive 2000 / 60 / ec of the european parliament and of the council of 23 october 2000 establishing a framework for community action in the field of water policy . 23 council directive 89 / 391 / eec of 12 june 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work . 24 regulation no 1907 / 2006 of the european parliament and of the council of 18 december 2006 concerning the registration , evaluation , authorisation and restriction of chemicals . 25 regulation no 1272 / 2008 of the european parliament and of the council of 16 december 2008 on classification , labelling and packaging of substances and mixtures . 26 commission regulation no 1881 / 2006 of 19 december 2006 setting maximum levels for certain contaminants in foodstuffs . 27 council directive 2000 / 29 / ec of 8 may 2000 on protective measures against the introduction into the community of organisms harmful to plants or plant products and against their spread within the community . 28 regulation no 98 / 2013 of the european parliament and of the council of 15 january 2013 on the marketing and use of explosives precursors . 29 regulation no 1143 / 2014 of the european parliament and of the council of 22 october 2014 on the prevention and management of the introduction and spread of invasive alien species . 29a council regulation no 834 / 2007 of 28 june 2007 on organic production and labelling of organic products .


### proposal for a regulation of the european parliament and of the council laying down common provisions on the european regional development fund , the european social fund plus , the cohesion fund , and the european maritime and fisheries fund and financial rules for those and for the asylum and migration fund , the internal security fund and the border management and visa instrument ### proposal for a regulation of the european parliament and of the council laying down common provisions on the european regional development fund , the european social fund plus , the cohesion fund , the european agricultural fund for rural development and the european maritime and fisheries fund and financial rules for those and for the asylum and migration fund , the internal security fund and the border management and visa instrument


### ' small project fund ' means an operation in an interreg programme aimed at the selection and implementation of projects of limited financial volume ; ### ' small project fund ' means an operation in an interreg programme aimed at the selection and implementation of people - to - people projects of limited financial volume ;


### at least once a year , the commission shall consult the organisations which represent the partners at union level on the implementation of programmes . ### at least once a year , the commission shall consult the organisations which represent the partners at union level on the implementation of programmes and shall report to the european parliament and the council on the outcome .


### the socio - economic situation of the member state or region concerned ; ### the socio - economic situation of the member state and region concerned ;


### the geographical area covered by the strategy ; ### the geographical area covered by the strategy based on economic , social and environmental functional links ;


### the objectives of that strategy , including measurable targets for results , and related planned actions ; ### the objectives of that strategy , including measurable targets for results , and related planned actions in response to local needs as identified by the local community ; predetermined actions not linked to local needs shall not be considered ;


### in addition to article 31 , the member state may propose to undertake additional technical assistance actions to reinforce the capacity of member state authorities , beneficiaries and relevant partners necessary for the effective administration and use of the funds . ### in addition to article 31 , the member state shall propose to undertake additional technical assistance actions to reinforce the capacity of member state authorities , beneficiaries and relevant partners necessary for the effective administration and use of the funds .


### the member state shall determine the composition of the monitoring committee and shall ensure a balanced representation of the relevant member state authorities and intermediate bodies and of representatives of the partners referred to in article 6 . ### the member state shall determine the composition of the monitoring committee , including , where applicable , sub - committees and steering committees , and shall ensure a balanced representation of the relevant member state authorities and intermediate bodies , taking into account the need for gender balance and of representatives of the partners referred to in article 6 .


### support from the funds to financial instruments invested in final recipients as well as any type of income generated by those investments , which are attributable to the support from the funds , may be used for differentiated treatment of investors operating under the market economy principle through an appropriate sharing of risks and profits . ### support from the funds to financial instruments invested in final recipients as well as any type of income generated by those investments , which are attributable to the support from the funds , may be used for differentiated treatment of investors operating under the market economy principle through an appropriate sharing of risks and profits taking into account the principle of sound financial management .


### for the selection of operations , the managing authority shall establish and apply criteria and procedures which are non - discriminatory , transparent , ensure gender equality and take account of the charter of fundamental rights of the european union and the principle of sustainable development and of the union policy on the environment in accordance with articles 11 and 191 of the tfeu . ### for the selection of operations , the managing authority shall establish and apply criteria and procedures which are non - discriminatory , transparent , ensure accessibility to persons with disabilities , ensure gender equality and take account of the charter of fundamental rights of the european union , the principle of sustainable development and of the union policy on the environment in accordance with articles 11 and 191 of the tfeu and the framework on sustainable investment in accordance with [ regulation on the establishment of a framework to facilitate sustainable investment ] .


### 2021 : 0 . 5 % ; ### 2021 : 1 % ;


### effective application of the partnership principle ### a framework is in place for all partners to play a fully - fledged role in the preparation , implementation , monitoring and evaluation of programmes , which includes arrangements to ensure transparent procedures for the involvement of partners 2 . arrangement for dissemination and disclosure of information relevant for partners to prepare and follow - up meetings 3 . support for empowering partners and capacity building


### national energy and climate plan are adopted and include : all elements required by the template in annex i of the regulation on governance of the energy union 2 . an indicative outline of envisaged financing resources and mechanisms for measures promoting low - carbon energy ### national energy and climate plan comply with the paris agreement objective of limiting global warming to 1 . 5°c , are adopted and include : all elements required by the template in annex i of the regulation on governance of the energy union 2 . an outline of envisaged financing resources and mechanisms for measures promoting low - carbon energy


### a priority action framework pursuant to article 8 of directive 92 / 43 / eec is in place and includes all elements required by the template for the priority action framework for 2021 - 2027 agreed by the commission and the member states 2 . the identification of the priority measures and an estimate of financing needs ### a priority action framework pursuant to article 8 of directive 92 / 43 / eec is in place and includes all elements required by the template for the priority action framework for 2021 - 2027 agreed by the commission and the member states including the priority measures and an estimate of financing needs


### measures to address gender gaps in employment , pay and pensions , and promote work - life balance , including through improving access to early childhood education and care , with targets ### measures to address gender gaps in employment , pay , social security , taxation and pensions , and promote work - life balance , including through improving access to early childhood education and care , with targets


### a national strategic policy framework for social inclusion and poverty reduction is in place that includes : evidence - based diagnosis of poverty and social exclusion including child poverty , homelessness , spatial and educational segregation , limited access to essential services and infrastructure , and the specific needs of vulnerable people 2 . measures to prevent and combat segregation in all fields , including through providing adequate income support , inclusive labour markets and access to quality services for vulnerable people , including migrants 3 . measures for the shift from institutional to community - based care 4 . arrangements for ensuring that its design , implementation , monitoring and review is conducted in close cooperation with social partners and relevant civil society organisations ### a national strategic policy framework and action plan for social inclusion and poverty reduction is in place that includes : evidence - based diagnosis of poverty and social exclusion including child poverty , homelessness , spatial and educational segregation , limited access to essential services and infrastructure , and the specific needs of vulnerable people 2 . measures to prevent and combat segregation in all fields , including through providing adequate income support , social protection , inclusive labour markets and access to quality services for vulnerable people , including migrants 3 . measures for the transition from institutional to family - and community - based care 4 . arrangements for ensuring that its design , implementation , monitoring and review is conducted in close cooperation with social partners and relevant civil society organisations


### the free movement of workers , freedom of establishment and freedom to provide services are fundamental principles of the internal market in the union enshrined in the treaty on the functioning of the european union . the implementation of those principles is further developed by the union aimed at guaranteeing a level playing field for businesses and respect for the rights of workers . ### the free movement of workers , freedom of establishment and freedom to provide services are fundamental principles of the internal market in the union enshrined in the treaty on the functioning of the european union and should therefore provide the combined legal basis for this directive . the implementation of those principles is further developed by the union aimed at guaranteeing a level playing field for businesses and fighting unfair competition as well as ensuring respect for the rights of workers and the improvement of the working environment and working conditions .


### in a competitive internal market , service providers compete not only on the basis of a labour costs but also on factors such as productivity and efficiency , or the quality and innovation of their goods and services . ### in a truly integrated internal market , ideally a level - playing field , service providers should be able to compete with regard to factors such as productivity , efficiency as well as the quality and innovation of their goods and services .


### - by collective agreements or arbitration awards which have been declared universally applicable within the meaning of paragraph 8 : ### - by all types of collective agreements or arbitration awards within the meaning of paragraphs 8 and 8a :


### member states shall publish in the single official national website referred to in article 5 of directive 2014 / 67 / eu the constituent elements of remuneration in accordance with point . ### member states shall publish in the single official national website and by other suitable means referred to in article 5 of directive 2014 / 67 / eu the constituent elements of remuneration .


### it is necessary to maintain a manual setting out the detailed rules for the exchange of certain supplementary information concerning the action called for by alerts . national authorities in each member state , should ensure the exchange of this information . ### it is necessary to maintain a manual setting out the detailed rules for the exchange of certain supplementary information concerning the action called for by alerts . national authorities in each member state , should ensure the immediate exchange of this information .


### in order to maintain the efficient exchange of supplementary information concerning the action to be taken specified in the alerts , it is appropriate to reinforce the functioning of the sirene bureaux by specifying the requirements concerning available resources , user training and the response time to the inquiries received from other sirene bureaux . ### in order to maintain the efficient and immediate exchange of supplementary information concerning the action to be taken specified in the alerts , it is appropriate to reinforce the functioning of the sirene bureaux by specifying the requirements concerning available resources , user training and the response time to the inquiries received from other sirene bureaux .


### to enhance the efficiency of the work of the immigration authorities when deciding about the right of third country nationals to enter and stay in the territories of the member states , as well as about the return of illegally staying third country nationals , it is appropriate to grant them access to sis under this regulation . ### to enhance the efficiency of the work of the immigration authorities when deciding about the right of third country nationals to enter and stay in the territories of the member states , as well as about the return of irregularly staying third country nationals , it is appropriate to grant them access to sis under this regulation .


### it is also necessary to set out clear rules for europol on the processing and downloading of sis data to allow the most comprehensive use of sis provided that data protection standards are respected as provided in this regulation and regulation 2016 / 794 . in cases where searches carried out by europol in sis reveal the existence of an alert issued by a member state , europol cannot take the required action . therefore it should inform the member state concerned allowing it to follow up the case . ### it is also necessary to set out clear rules for europol on the processing and downloading of sis data to allow the most comprehensive use of sis provided that data protection standards are respected as provided by union law . in cases where searches carried out by europol in sis reveal the existence of an alert issued by a member state , europol cannot take the required action . therefore it should immediately inform the member state concerned allowing it to follow up the case .


### before being authorised to process data stored in sis and periodically after access to sis data has been granted , the staff of the authorities having a right to access sis shall receive appropriate training about data - security , data - protection rules and the procedures on data processing as set out in the sirene manual . the staff shall be informed of any relevant criminal offences and penalties . ### before being authorised to process data stored in sis and periodically after access to sis data has been granted , the staff of the authorities having a right to access sis shall receive appropriate training about data - security , fundamental rights including data - protection rules and the procedures on data processing as set out in the sirene manual . the staff shall be informed of any relevant criminal offences and penalties .


### data on third - country nationals in respect of whom an alert has been issued for the purposes of refusing entry and stay shall be entered in sis on the basis of a national alert resulting from a decision taken by the competent administrative or judicial authorities in accordance with the rules of procedure laid down by national law taken on the basis of an individual assessment . appeals against those decisions shall be made in accordance with national law . ### data on third - country nationals in respect of whom an alert has been issued for the purposes of refusing entry and stay shall be entered in sis on the basis of a national alert resulting from a decision in force taken by the competent administrative or judicial authorities in accordance with the rules of procedure laid down by national law taken on the basis of an individual assessment . appeals against those decisions shall be made in accordance with national law . such appeals shall include an effective remedy before a tribunal .


### an alert shall be entered where the decision referred to in paragraph 1 is based on a threat to public policy or public security or to national security which the presence of the third - country national in question in the territory of a member state may pose . this situation shall arise in particular in the case of : ### an alert shall be entered where the decision referred to in paragraph 1 is based on a threat to public policy or public security or to national security which the presence of the third - country national in question in the territory of a member state may pose . this situation shall arise in the case of :


### dactylographic data may also be used to identify a person . dactylographic data stored in sis shall be used for identification purposes if the identity of the person cannot be ascertained by other means . ### dactylographic data stored in sis may also be used for identification purposes if the identity of the person cannot be ascertained by other means .


### where a search by europol reveals the existence of an alert in sis , europol shall inform the issuing member state via the channels defined by regulation 2016 / 794 . ### where a search by europol reveals the existence of an alert in sis , europol shall immediately inform the issuing member state via the channels defined by regulation 2016 / 794 .


### where a search by a member of the european border and coast guard teams or teams of staff involved in return - related tasks or by a member of the migration management support teams reveals the existence of an alert in sis , the issuing member state shall be informed thereof . in accordance with article 40 of regulation 2016 / 1624 , members of the teams may only act in response to an alert in sis under instructions from and , as a general rule , in the presence of border guards or staff involved in return - related tasks of the host member state in which they are operating . the host member state may authorise members of the teams to act on its behalf . ### where a search by a member of the european border and coast guard teams or teams of staff involved in return - related tasks or by a member of the migration management support teams reveals the existence of an alert in sis , the issuing member state shall be immediately informed thereof . in accordance with article 40 of regulation 2016 / 1624 , members of the teams may only act in response to an alert in sis under instructions from and , as a general rule , in the presence of border guards or staff involved in return - related tasks of the host member state in which they are operating . the host member state may authorise members of the teams to act on its behalf .


### except where necessary to perform the tasks for the purposes of the regulation establishing a european travel information and authorisation system no parts of sis shall be connected to any computer system for data collection and processing operated by or at the european border and coast guard agency nor shall the data contained in sis to which the european border and coast guard agency has access be transferred to such a system . no part of sis shall be downloaded . the logging of access and searches shall not be construed to be the downloading or copying of sis data . ### no parts of sis shall be connected to any computer system for data collection and processing operated by or at the european border and coast guard agency nor shall the data contained in sis to which the european border and coast guard agency has access be transferred to such a system . no part of sis shall be downloaded . the logging of access and searches shall not be construed to be the downloading or copying of sis data .


### alerts entered in sis pursuant to this regulation shall be kept only for the time required to achieve the purposes for which they were entered . ### alerts entered in sis pursuant to this regulation shall not be kept longer than for the time required to achieve the purposes for which they were entered .


### in cases where it becomes clear to staff in the sirene bureau , who are responsible for coordinating and verifying of data quality , that an alert on a person has achieved its purpose and should be deleted from sis , the staff shall notify the authority which created the alert to bring this issue to the attention of the authority . the authority shall have 30 calendar days from the receipt of this notification to indicate that the alert has been or shall be deleted or shall state reasons for the retention of the alert . if the 30 - day period expires without such a reply the alert shall be deleted by the staff of the sirene bureau . sirene bureaux shall report any recurring issues in this area to their national supervisory authority . ### in cases where it becomes clear to staff in the sirene bureau , who are responsible for coordinating and verifying of data quality , that an alert on a person has achieved its purpose and should be deleted from sis , the staff shall immediately notify the authority which created the alert to bring this issue to the attention of the authority . the authority shall have 30 calendar days from the receipt of this notification to indicate that the alert has been or shall be deleted or shall state reasons for the retention of the alert . if the 30 - day period expires without such a reply the alert shall be deleted by the staff of the sirene bureau . sirene bureaux shall report any recurring issues in this area to their national supervisory authority .


### each member state shall send to the agency a list of its competent authorities which are authorised to search directly the data contained in sis pursuant to this regulation , as well as any changes to the list . the list shall specify , for each authority , which data it may search and for what purposes . the agency shall ensure the annual publication of the list in the official journal of the european union . ### each member state shall send to the agency a list of its competent authorities which are authorised to search directly the data contained in sis pursuant to this regulation , as well as any changes to the list . the list shall specify , for each authority , which data it may search and for what purposes . the agency shall ensure the annual publication of the list on its website and in the official journal of the european union .