### 2. producers shall make available to distributors and operators referred to in articles 50 , 52 and 53 and other waste management operators carrying out repair , remanufacturing , preparing for re-use , treatment and recycling activities information regarding the safety and protective measures , including on occupational safety , applicable to the storage and collection of waste batteries. ### 2. producers shall make available to distributors and operators referred to in articles 50 , 52 and 53 and other waste management operators carrying out repair , remanufacturing , preparing for re-use , treatment and recycling activities information regarding the safety and protective measures , including on occupational and fire safety , applicable to the storage and collection of waste batteries.


### 3. from the moment that a battery model is supplied within the territory of a member state producers shall make available electronically , upon request , to waste management operators carrying out repair , remanufacturing , preparing for re-use , treatment and recycling activities , as far as it is needed by those operators to carry out those activities , the following battery model specific information regarding the proper and environmentally sound treatment of waste batteries: ### 3. from the moment that a battery model is supplied within the territory of a member state producers shall make available electronically , free of charge upon request , to waste management operators carrying out repair , remanufacturing , preparing for re-use , treatment and recycling activities , as far as it is needed by those operators to carry out those activities , the following battery model specific information regarding the proper and environmentally sound treatment of waste batteries:


### the safety and protective measures , including on occupational safety , applicable to the storage , transport , treatment and recycling processes for waste batteries. ### the safety and protective measures , including on occupational safety and fire protection measures , applicable to the storage , transport , treatment and recycling processes for waste batteries.


### 4. distributors that supply batteries to end-users shall provide in their retail premises , in a visible manner , and through their online marketplaces the information listed in paragraph 1 and 2 , and information on how the end users may return waste batteries free of charge to the respective collection points established at retail outlets or on behalf of a marketplace. that obligation shall be limited to the types of batteries which the distributor or retailer has , or had , as new batteries in its offer. ### 4. distributors that supply batteries to end-users shall permanently provide in their retail premises and/or online marketplaces , in a easily accessible and clearly visible manner for the end-users of the battery , the information and through their online marketplaces the information listed in paragraph 1 and 2 , and information on how the end users may return waste batteries free of charge to the respective collection points established at retail outlets or on behalf of a marketplace. that obligation shall be limited to the types of batteries which the distributor or retailer has , or had , as new batteries in its offer.


### where waste management operators other than producers or , where appointed in accordance with article 47(2) , producer responsibility organisations acting on their behalf , collect waste portable batteries from distributors or other collection points for waste portable batteries , they shall report to the competent authority for each calendar year the amount of waste portable batteries collected according to their chemistry and specifying the amounts of batteries powering light means of transport. ### where waste management operators other than producers or , where appointed in accordance with article 47(2) , producer responsibility organisations acting on their behalf , collect waste portable batteries from distributors or other collection points for waste portable batteries , they shall report to the competent authority for each calendar year the amount of waste portable batteries collected according to their chemistry.


### 3. where waste management operators collect waste batteries from distributors or other waste automotive , industrial and electric vehicle batteries collection points or end-users , they shall report to the competent authority for each calendar year the following information according to their chemistries and types of batteries: ### deleted


### 1. by 1 january 2026 , the commission shall set up the electronic exchange system for battery information (“the system”). ### 1. by [48 months after the entry into force of the regulation] , the commission shall set up the electronic exchange system for battery information (“the system”).


### 2. the system shall contain the information and data on rechargeable industrial batteries and electric vehicle batteries with internal storage and a capacity above 2 kwh as laid down in annex xiii. that information and data shall be sortable and searchable , respecting open standards for third party use. ### 2. the system shall contain the information and data on light means of transport batteries , industrial batteries and electric vehicle batteries as laid down in annex xiii. that information and data shall be sortable and searchable , respecting open standards for third party use.


### 3. the economic operators that place a rechargeable industrial battery or an electric vehicle battery with internal storage on the market shall make the information referred to in paragraph 2 available electronically in a machine readable format using interoperable and easily accessible data services in the format established in accordance with paragraph 5. ### 3. by [12 months after the adoption of the implementing acts referred to in paragraph 5] and no later than 1 january 2026 economic operators that place a light means of transport battery , industrial battery or an electric vehicle battery on the market shall make the information referred to in paragraph 2 available electronically in a machine readable format using interoperable and easily accessible data services in the format established in accordance with paragraph 5.


### 1. by 1 january 2026 , each industrial battery and electric vehicle battery placed on the market or put into service and whose capacity is higher than 2 kwh shall have an electronic record (“battery passport”). ### 1. by [48 months after the entry into force of the regulation] , each light means of transport battery , industrial battery and electric vehicle battery placed on the market or put into service shall have an electronic record (“battery passport”).


### 2. the battery passport shall be unique for each individual battery referred to in paragraph 1 and shall be identified through a unique identifier that the economic operator placing the battery on the market shall attribute to it and which shall be printed or engraved on it. ### 2. the battery passport shall be unique for each individual battery referred to in paragraph 1 and shall be accessible via the qr-code referred to in article 13 (5).


### 6. when the change in the status is due to repairing or repurposing activities , the responsibility for the battery record in the battery passport shall be transferred to the economic operator that is considered to place the industrial battery or the electric vehicle battery on the market or that puts it into service. ### 6. when the change in the status is due to repairing or repurposing activities , the responsibility for the battery record in the battery passport shall be transferred to the economic operator that is considered to place the industrial battery , the electric vehicle battery or the light means of transport battery on the market or that puts it into service. the record for repurposed or remanufactured batteries shall be linked to the record of the original battery.


### 7. the commission is empowered to adopt implementing acts to establish the rules for accessing , sharing , managing , exploring , publishing and reusing of the information and data accessible through the battery passport. ### 7. the commission is shall by 31 december 2024 adopt delegated acts , which respect intellectual property and property rights , to establish the rules for accessing , sharing , managing , exploring , publishing and reusing of the information and data accessible through the battery passport.


### those implementing acts shall be adopted in accordance with the examination procedure referred to in article 74(3). ### those delegated acts shall be adopted in accordance with the examination procedure referred to in article 73.


### 1. contracting authorities , as defined in article 2(1) of directive 2014/24/eu or article 3(1) of directive 2014/25/eu , or contracting entities , as defined in article 4(1) of directive 2014/25/eu shall , when procuring batteries or products containing batteries in situations covered by those directives , take account of the environmental impacts of batteries over their life cycle with a view to ensure that such impacts of the batteries procured are kept to a minimum. ### 1. contracting authorities , as defined in article 2(1) of directive 2014/24/eu or article 3(1) of directive 2014/25/eu , or contracting entities , as defined in article 4(1) of directive 2014/25/eu shall , when procuring batteries or products containing batteries in situations covered by those directives , make sure that producers of batteries have registered to fulfil their extended producer responsibility for batteries and take account of the environmental impacts of batteries over their life cycle with a view to ensure that such impacts of the batteries procured are kept to a minimum.


### 2. the obligation set out in paragraph 1 shall apply to any contracts entered into by contracting authorities or contracting entities for the purchase of batteries or products containing batteries and shall mean that these contracting authorities and contracting entities are obliged to include technical specifications and award criteria based on articles 7 to 10 to ensure that a product is chosen among products with significantly lower environmental impacts over their lifecycle. ### 2. the obligation set out in paragraph 1 shall apply to any contracts entered into by contracting authorities or contracting entities for the purchase of batteries or products containing batteries and shall mean that these contracting authorities and contracting entities are obliged to include technical specifications and award criteria based on articles 7 to 10 and 39 to ensure that a product is chosen among products with significantly lower environmental impacts over their lifecycle.


### it shall apply from 1 january 2022. ### it shall apply from [6 months after the entry into force of the regulation].


### it shall apply from 1 january 2022. ### it shall apply from xx.


### — weighs below 5 kg; ### — has a capacity of under 2 kwh;


### (12) ‘electric vehicle battery’ means any battery specifically designed to provide traction to hybrid and electric vehicles for road transport; ### (12) ‘electric vehicle battery’ means any battery specifically designed to provide traction to hybrid and electric vehicles for road transport , excluding portable batteries used in light means of transport and in other individual urban transport modes;


### (22) ‘battery management system’ means an electronic device that controls or manages the electric and thermal functions of the battery , that manages and stores the data on the parameters for determining the state of health and expected lifetime of batteries laid down in annex vii and that communicates with the vehicle or appliance in which the battery is incorporated; ### (22) ‘battery management system’ means an electronic device that controls or manages the electric and thermal functions of the battery , that manages and stores the data on the parameters for determining the safety , the state of health and expected lifetime of batteries laid down in annex vii and that communicates with the vehicle or appliance in which the battery is incorporated;


### 1. rechargeable industrial batteries and electric vehicle batteries with internal storage and a capacity above 2 kwh shall include a battery management system containing data on the parameters for determining the state of health and expected lifetime of batteries as laid down in annex vii. ### 1. stationary energy storage batteries and electric vehicle batteries using lithium-ion and sodium shall include a battery management system containing data on the parameters for determining the state of health and expected lifetime of batteries as laid down in annex vii.


### 39 obligation for economic operators that place rechargeable industrial batteries and electric-vehicle batteries with internal storage and a capacity above 2 kwh on the market to establish supply chain due diligence policies ### 39 obligation for economic operators that place rechargeable industrial batteries and electric-vehicle batteries with internal storage and a capacity above 2 kwh or portable batteries used in light means of transport and in other individual urban transport modes on the market to establish supply chain due diligence policies


### obligation for economic operators that place rechargeable industrial batteries and electric-vehicle batteries with internal storage and a capacity above 2 kwh on the market to establish supply chain due diligence policies ### obligation for economic operators that place batteries on the market to establish supply chain due diligence policies


### 1. as of [12 months after the entry into force of the regulation] the economic operator that places rechargeable industrial batteries and electric-vehicle batteries with internal storage and a capacity above 2 kwh on the market shall comply with the supply chain due diligence obligations set out in paragraphs 2 to 5 of this article and shall keep documentation demonstrating its respective compliance with those obligations , including the results of the third-party verification carried out by notified bodies. ### 1. as of [12 months after the entry into force of the regulation] the economic operator that places batteries on the market shall comply with the supply chain due diligence obligations set out in paragraphs 2 to 5 of this article and shall keep documentation demonstrating its respective compliance with those obligations , including the results of the third-party verification carried out by notified bodies.


### incorporate in its supply chain policy standards consistent with the standards set out in the model supply chain policy in annex ii to the oecd due diligence guidance; ### incorporate in its supply chain policy standards consistent with the standards set out in the model supply chain policy in annex ii to the oecd due diligence guidance , the un guiding principles on business and human rights and oecd guidelines for multinational enterprises;


### such a system shall be supported by documentation that provides the following information: ### such a system shall be supported by documentation that provides at least the following information:


### (ii) adopting risk management measures consistent with annex ii to the oecd due diligence guidance , considering their ability to influence , and where necessary take steps to exert pressure on suppliers who can most effectively prevent or mitigate the identified risk; ### (ii) adopting risk management measures consistent with annex ii to the oecd due diligence guidance , the un guiding principles on business and human rights and oecd guidelines for multinational enterprises , considering their ability to influence , and where necessary take steps to exert pressure on suppliers who can most effectively prevent or mitigate the identified risk;


### 3. the delegation of power referred to in articles 6(2) , 7(1) , (2) and (3) , 9(2) , 10(3) , 12(2) , 17(4) , 27(3) , 39(8) , 55(4) , 56(4) , 57(6) , 58(3) and 70(2) may be revoked at any time by the european parliament or by the council. a decision to revoke shall put an end to the delegation of the power specified in that decision. it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein. it shall not affect the validity of any delegated acts already in force. ### 3. the delegation of power referred to in articles 6(2) , 7(1) , (2) and (3) , 9(2) , 10(3) , 12(2) , 17(4) , 27(3) , 39(8) , 55(4) , 56(4) , 57(4) and (6) , 58(3) and 70(2) may be revoked at any time by the european parliament or by the council. a decision to revoke shall put an end to the delegation of the power specified in that decision. it shall take effect the day following the publication of the decision in the official journal of the european union or at a later date specified therein. it shall not affect the validity of any delegated acts already in force.


### 6. thermal propagation ### 6. thermal propagation protection


### 7. mechanical damage by external forces (drop and impact) ### 7. mechanical damage protection


### these tests shall simulate one or more situations in which a battery accidentally drops or is impacted by a heavy load and remains operational for the purpose for which it was designed. the criteria to simulate these situations should reflect real life uses. ### these tests shall simulate one or more situations in which a battery is accidentally exposed to mechanical stresses and remains operational for the purpose for which it was designed. the criteria to simulate these situations should reflect real life uses.


### ilo tripartite declaration of principles concerning multinational enterprises and social policy; ### ilo tripartite declaration of principles concerning multinational enterprises and social policy , and the fundamental conventions listed in annex i of the declaration;


### c. whereas , despite the lack of comprehensive data on its full impact , the number of companies operating in the market since the full application of the tsd increased by 10 % from 2013 to 2017 , while the turnover of the eu toy industry has constantly increased since its entry into force; whereas 99 % of companies in the sector are smes; ### c. whereas , despite the lack of comprehensive data on its full impact , the number of companies operating in the market since the full application of the tsd increased by 10 % from 2013 to 2017 , while the turnover of the eu toy industry has constantly increased since its entry into force; whereas 99 % of companies in the sector are smes; and the majority of these companies are micro-enterprises; whereas the joint research centre has estimated that the tsd has led to a 13% increase of costs for materials for small & medium sized eu manufacturers.


### d. whereas scientific and technological developments show the constant emergence of previously unknown risks and challenges related to toys that call for quick adaptations; ### d. whereas the toy safety directive requires that toys , including the chemicals they contain , are safe , specific requirements and standards can be adapted in case of scientific and technological developments that show the constant emergence of previously unknown risks and challenges related to toys;


### 1. welcomes the commission’s evaluation report on the tsd , aiming at assessing its functioning since its entry into force; ### 1. welcomes the commission’s evaluation report on the tsd , aiming at assessing its functioning since its entry into force; regrets the lack of harmonization in the elaboration of the reports and also in data gathering; stresses the need for transparency and urges the member state and the commission to publish the periodic reports from all the ms;


### 2. acknowledges the added value of the tsd in improving the safety of children and ensuring an equal level of protection across the single market , compared to the previous directive , and its role in providing legal certainty and a level playing field for businesses; ### 2. acknowledges the added value of the tsd in improving the safety of children and ensuring an equal level of protection across the single market , compared to the previous directive , and its role in providing legal certainty and a level playing field for the businesses from european union; regrets that a big part of the third country manufacturers that are selling their products in thesingle market , especially through the on-line market , do not comply with the european legislation and many toys sold in the eu are still posing significantly , sometimes deadly , threats to children;


### 3. recognises the key role of standards in allowing for the efficient and agile application of the directive by manufacturers , as well as the role of notified bodies in ensuring compliance when standards are not available or are not applied; ### 3. recognises the key role of standards in allowing for the efficient and agile application of the directive by manufacturers , as well as the role of notified bodies in ensuring compliance when standards are not available or are not applied; regrets the scarcity of the notified bodies insome regions or member states;


### 4. notes , however , that inconsistencies that call for a revision of the tsd remain; ### 4. notes , however , that inconsistencies that call for a revision of the tsd remain; further efforts are needed to ensure the strict safety requirements that are applied by all economic operators and that children enjoy a similar level of protection in relation to other products designed for their use; invites the commission to continue its evaluation process before a possible revision of the tsd to have targeted updates on the legislation , if needed.


### 1. welcomes the communication on an intellectual property action plan to support the eu’s recovery and resilience , but regrets that the focus on international cooperation and assistance to developing countries is poorly addressed; ### 1. welcomes the communication on an intellectual property action plan to support the eu’s recovery and resilience , but regrets that the focus on international cooperation and assistance to developing countries is poorly addressed; in this regard , calls on the eu to assume the role of a key global player in the field of intellectual property and to lead international efforts in order to accelerate and facilitate the sustainable development of low and middle income countries;


### 2. calls on the commission to continue strengthening intellectual property rights (ipr) protection and enforcement in non-eu countries through eu-funded technical cooperation programmes; welcomes in particular the intention to promote better generation and management of intellectual property (ip) on the african continent as part of a joint partnership building on the current four-year cooperation programme for africa; ### 2. calls on the commission to continue strengthening intellectual property rights (ipr) protection and enforcement in non-eu countries through eu-funded technical cooperation programmes; in this context , encourages the commission , on the basis of the eu’s experience , to assist and provide policy makers and enforcement authorities with knowledge and guidelines for improving the capacity to tackle infringements of ipr , and to promote feasible solutions , which could significantly reduce costs and simplify the procedures for obtaining , maintaining and enforcing the protection of iprs , as well as to give information to rights holders about the changing infringement landscape and the supply of counterfeit goods; welcomes in particular the intention to promote better generation and management of intellectual property (ip) on the african continent as part of a joint partnership building on the current four-year cooperation programme for africa;


### 3. is convinced that support for smes , including financial and non-financial measures , is the right way to provide them with better access to iprs and that the union’s financial instruments are of the utmost importance in this context; calls on the commission and the euipo , therefore , to continue implementing ip management support measures for smes in the context of the economic recovery , including the provision of one-stop shop access to information and related services and advice about ip; ### 3. is convinced that support for smes , including financial and non-financial measures , is the right way to provide them with better access to iprs and that the union’s financial instruments are of the utmost importance in this context; calls on the commission and the euipo , therefore , to continue implementing ip management support measures for smes in the context of the economic recovery , including the provision of one-stop shop access to information and related services and advice about ip; stresses that this support will help to leverage and promote all national and regional initiatives of members of the european union intellectual property network (euipn);


### 3. strongly encourages the commission to assist producers and their associations as well as local authorities in developing countries in unlocking the potential of ip and reaping the economic value of local innovations , geographical indications and traditional knowledge; reiterates its call , in this regard , to respect the progress achieved in the international protection of indigenous peoples’ rights over their genetic resources and associated traditional knowledge; ### 3. strongly encourages the commission to assist producers and their associations as well as local authorities in developing countries in unlocking the potential of ip and reaping the economic value of local innovations , geographical indications and traditional knowledge; reiterates its call , in this regard , to respect the progress achieved in the international protection of indigenous peoples’ rights over their genetic resources and associated traditional knowledge;  calls on the commission to increase efforts to offer qualified consulting services with the purpose to help innovative enterprises at the different stages of the research and innovation process , as well as to provide technical assistance and raise awareness as to the significance of the new opportunities which new technologies and digital means offer , since a well functioning ip framework is of utmost importance for growth and competitiveness;


### 4. recognises that ip systems contribute to the development of new medicines , but stresses that they must comply with international human rights law and public health requirements; notes that strong iprs may limit access to medicines in developing countries while not necessarily encouraging pharmaceutical innovation that responds to the needs of developing countries; ### 4. recognises that ip systems contribute to the development of new medicines , but stresses that they must comply with international human rights law and public health requirements; acknowledges that ip systems are needed , as through them it is possible to search for , design and disseminate viable solutions and mechanisms for prevention and for building resilience to health related issues , and that such systems contribute to strengthening abilities for instigating positive change and progress; notes , however , that strong iprs may in some cases limit access to medicines in developing countries while not necessarily encouraging pharmaceutical innovation that responds to the needs of developing and least developed countries;


### 4. recognises that ip systems contribute to the development of new medicines , but stresses that they must comply with international human rights law and public health requirements; notes that strong iprs may limit access to medicines in developing countries while not necessarily encouraging pharmaceutical innovation that responds to the needs of developing countries; ### 4. recognises that ip systems contribute to the development of new medicines , but stresses that they must comply with international human rights law and public health requirements; notes that intellectual property protection is an enabler for global production and distribution of vaccines and other medicines , as well as research , development and innovation , and that intellectual property protection creates an environment of trust for producers and investors , as well as long-term certainty;


### 5. welcomes , as a positive step , the recently announced us support for a proposal to temporarily waive certain provisions of the agreement on trade-related aspects of intellectual property rights for the prevention , containment and treatment of covid-19; urges the commission , therefore , to follow through on its promise to engage in active and constructive text-based negotiations at world trade organization level. ### 5. notes the recently announced us support for a proposal to temporarily waive certain provisions of the agreement on trade-related aspects of intellectual property rights for the prevention , containment and treatment of covid-19; supports the eu in their discussions within the wto on flexibilities within the trips agreement; calls in this regard for a thorough analysis on how to apply and successfully implement article 31bis of the trips agreement and enable exporting licenses to countries that cannot satisfy domestic demand;


### 5. welcomes , as a positive step , the recently announced us support for a proposal to temporarily waive certain provisions of the agreement on trade-related aspects of intellectual property rights for the prevention , containment and treatment of covid-19; urges the commission , therefore , to follow through on its promise to engage in active and constructive text-based negotiations at world trade organization level. ### 5. notes the recently announced united states’ support for waiving intellectual property protections for covid-19 vaccines; in this light , recalls the commission’s statement that the eu is ready to conduct discussions on the possible impacts of a temporary waiver of trips provisions , and that overcoming the world's production difficulties , as well as investments and contributions to the covax system are key priorities for expanding the global access to vaccines;


### 7. stresses that the supplementary protection certificate (spc) regime within the eu , while of great practical relevance , suffers from fragmented implementation across the member states; ### 7. stresses that the supplementary protection certificate (spc) regime within the eu , while of great practical relevance , suffers from fragmented implementation across the member states; urges the commission to issue guidelines for the member states and address this fragmentation , including by legislative proposals;


### 12. asks the commission to further investigate , together with the relevant stakeholders , the requirements for an independent system of third-party essentiality checks by identifying the demand for , assessing the impact of and defining the role that resources such as emerging technologies like ai and/or technical expertise contributed by the epo could play in that context , and to use the knowledge gained as input for the legislative initiative on sep envisaged for the beginning of 2022; ### 12. asks the commission to further investigate , together with the relevant stakeholders , the requirements for an independent system of third-party essentiality checks by identifying the demand for , assessing the impact of and defining the role that resources such as emerging technologies like ai and/or technical expertise contributed by the epo could play in that context , and to use the knowledge gained as input for the legislative initiative on sep envisaged for the beginning of 2022 based on appropriate impact assessments;


### 14. supports the commission in its initiative to establish eu sui generis protection of geographical indications (gis) for non-agricultural products in order to align to the geneva act of the lisbon agreement on appellations of origin and geographical indications , which includes the possibility to protect gis for both agricultural and non-agricultural products; ### 14. supports the commission in its initiative to establish eu sui generis protection of geographical indications (gis) for non-agricultural products in order to align to the geneva act of the lisbon agreement on appellations of origin and geographical indications , which the eu has signed and which includes the possibility to protect gis for both agricultural and non-agricultural products; expects the commission to propose legislation in this regard as soon as possible and at the end of 2021 at the latest;


### 16. welcomes the commission’s willingness to revise union legislation on design protection to better support the transition to the digital and green economy and calls on the commission to update the registration procedure to allow for new forms of design to be protected in an easy and less burdensome way; ### 16. welcomes the commission’s willingness to revise union legislation on design protection to better support the transition to the digital and green economy and calls on the commission to update the registration procedure to allow for new forms of design to be protected in an easy and less burdensome way; calls on the commission to further harmonise the application and invalidation procedures in the member states;


### 18. stresses that while rights attached to trade marks are enforceable against infringing goods transiting though the eu , those attached to design are not; calls on the commission to close this gap in the revision of the design legislation and make it possible for brand owners to put a stop to design counterfeits transiting through the eu; ### 18. stresses that while rights attached to trade marks are enforceable against infringing goods transiting though the eu , those attached to design are not; calls on the commission to close this gap in the revision of the design legislation and make it possible for brand owners to put a stop to design counterfeits transiting through the eu; believes that the eu design protection system should be aligned with the eu trademark system in order to allow for design holders to prevent design infringing goods to enter into the eu’s customs territory and should encompass all customs situations , including situations , where such goods are not intended to be released for free circulation in the european union;


### 19. points out that counterfeit goods , in particular counterfeit medicines and fake personal protective equipment and masks in the context of the covid-19 pandemic , can have serious impacts on the health of eu citizens and can cause serious harm to public health; ### 19. points out that counterfeit goods , such as , for example , counterfeit medicines or fake personal protective equipment or masks in the context of the covid-19 pandemic , can have serious impacts on the health of eu citizens and can cause serious harm to public health; argues that although market surveillance activities are aimed at protecting general public interests , while counterfeited products relate to the protection of private intellectual property rights , there is a close relation between counterfeited products and risks to health and safety of consumers;


### 21. stresses that the internet is significantly used to distribute counterfeit products and ipr-infringing services and welcomes the proposal of the commission for a digital services act; highlights the fact that proactive measures from intermediaries would contribute enormously to the fight against counterfeiting and that ai and blockchain could play an important role in detecting counterfeit and piracy and enforcing ipr in the whole supply chain; supports , therefore , the use of new technologies to combat ip infringements and welcomes publications produced by the euipo observatory; ### 21. stresses that the internet is significantly used to distribute counterfeit products and ipr-infringing services and welcomes the proposal of the commission for a digital services act; highlights the fact that proactive measures from intermediaries would contribute enormously to the fight against counterfeiting and that ai and blockchain could play an important role in detecting counterfeited and pirated goods available online as well as contribute to enhanced enforcement of ipr in the whole supply chain , from extracting raw materials to selling the final product; supports , therefore , the use of new technologies to combat ip infringements and welcomes publications produced by the euipo observatory in this respect , in order to further promote the use of these new technologies;


### 23. highlights that ip protection related to ai technologies is important and that even though current rules on the protection of computer-implemented inventions by patents may cover ai technologies , clear criteria for the protection of inventions created with the help of ai technologies are necessary; asks the commission , therefore , in cooperation with the epo and euipo , to provide legal certainty on this subject and to follow the issue closely at international level in the wipo; ### 23. highlights that ip protection related to ai technologies is important and that even though current rules on the protection of computer-implemented inventions by patents may cover ai technologies , clear criteria for the protection of inventions created with the help of ai technologies are necessary; asks the commission , therefore , in cooperation with the epo and euipo , to provide legal certainty on this subject and to follow the issue closely at international level in the wipo; underlines that ai and related technologies used for the registration procedure to grant iprs cannot be a substitute for human review carried out on a case-by-case basis , in order to ensure the quality and fairness of decisions;


### 24. regrets the fact that the commission’s 2016 study on patent assertion entities (pae) in europe10 did not provide a clear answer to the question of whether the business models of some pae , consisting in acquiring patents from third parties and seeking to generate revenue by asserting them against alleged infringers by misusing litigation asymmetries , abuse loopholes in existing legislation and therefore constitute a problem that should be tackled; calls the commission to carry out an in-depth study on this issue; ### 24. recalls the fact that the commission’s 2016 study on "patent assertion entities (pae) in europe"10 concluded that the eu legal framework already provides for safeguards against abusive behaviour; nevertheless encourages the european commission to continue monitoring this issue and to carry out in-depth studies where needed;


### 26. suggests that an ip coordinator be established at european level in order to ensure a holistic and coordinated approach to eu ip policy and enhance cooperation between the different national ip authorities , the directorates-general of the commission and other bodies in charge of ipr , such as the epo , euipo and wipo; ### 26. suggests that , as a political priority , an ip coordinator be established at european level in order to ensure a holistic and coordinated approach to eu ip policy and enhance cooperation between the different national ip authorities , the directorates-general of the commission and other bodies in charge of ipr , such as the epo , euipo and wipo; the ip coordinator would further promote the fight against counterfeiting at highest political level , which becomes necessary due to the scale of practice of counterfeiting , its upwards trend and the negative impact counterfeited goods have on consumers and businesses alike;


### 3. highlights the importance of enhancing the resilience of regional and local food systems , as well as of short supply chains , as set out in the farm to fork strategy; stresses , however , that the strategy should not lead to additional barriers and greater fragmentation within the single market; ### 3. highlights the importance of enhancing the resilience of regional and local food systems , as well as of short supply chains , as set out in the farm to fork strategy; stresses that the strategy will have to maintain , as well as allow the creation of new opportunities for all european products within the single market;


### 5. considers it unacceptable that quality differences exist between food products which are advertised and distributed in the single market under the same brand name and with the same packaging; welcomes the commission’s incentives to address the issue of dual food quality in the single market. ### 5. considers it unacceptable that quality differences exist between food products which are advertised and distributed in the single market under the same brand name and with the same packaging; welcomes the commission’s incentives to address the issue of dual food quality in the single market; recalls , with the aim of coherence between our political strategies , the support of the european parliament to the request of the consumers to benefit from more information;


### 9. recognises the insufficient use of the notification procedure under the services directive; calls on the commission to reflect on improving this framework , possibly by means of a new initiative which would increase clarity and transparency on the measures that need to be notified , while remaining cautious in order to not undermine the services directive and avoiding the situation which led to the withdrawal of the previous proposal; ### 9. regrets the insufficient use of the notification procedure under the services directive and the tris notification system (directive (eu) 2015/1535); calls on member states to fulfil their notification obligations; calls on the commission to improve this framework , possibly by means of a new initiative which would increase clarity and transparency on the measures that need to be notified , while remaining cautious in order to not undermine the services directive and avoiding the situation which led to the withdrawal of the previous proposal;


### 10. stresses that barriers also derive from limited national administration capabilities to provide services in other languages , and from shortages of skills and infrastructure; ### 10. stresses that barriers also derive from limited national administration capabilities to provide services in other languages , and from shortages of skills and infrastructure; calls on member states to ensure that information and documents relating to market access are not only available in the official language of the member state but also in english and other eu languages;


### 12. considers that mutual recognition of professional qualification is seriously affected by administrative barriers imposed by member states; ### 12. regrets that mutual recognition of professional qualification is seriously restricted by administrative barriers imposed by member states; underlines that the automatic mutual recognition of diplomas , qualifications , skills and competences between member states would strengthen the free movement of workers and services and urges member states to extend mutual recognition to all levels of education and training and to improve or introduce the necessary procedures for that as soon as possible; encourages the commission to eliminate undue restrictions on professional qualifications and to remain vigilant in pursuing infringement policies where member states do not comply with eu legislation on the recognition of qualifications;


### 13. is concerned by the insufficient access to information on mobility of services , as well as by the burdensome procedures to obtain essential documents such as the a1 form; underlines that access to information , such as on domestic collective agreements where applicable and relevant , should be improved to facilitate compliance for businesses; ### 13. is concerned by the insufficient access to information on mobility of services , as well as by the burdensome procedures in certain member states to obtain essential documents such as the a1 form; calls on member states to commit to providing the a1 form at short notice and , where possible , digitally; underlines that access to information , such as on domestic collective agreements where universally applicable and relevant , is obligatory under directive 2014/67/ec and should be improved to facilitate compliance for businesses , this information should be available via the single digital gateway; calls on member states to avoid creating disproportionate burdens for companies in the implementation of posting legislation and on the commission to further harmonise existing rules;


### 14. recognises that numerous barriers stem from the limited capacity of administrations to deliver high quality services in cross-border settings; believes that digitalisation of public services and fully-fledged egovernment capabilities remain essential to eradicate some of the onerous ntbs; recalls , in this regard , that the key provisions of the single digital gateway had to be in force in all eu member states by 12 december 2020; underlines the importance of the ‘once only’ principle , which will save citizens and businesses time and money , in particular if used more widely; welcomes the proposal to add a single market obstacles tool to the single digital gateway; ### 14. recognises that numerous barriers stem from the limited capacity of administrations to deliver high quality services in cross-border settings; calls on the commission to promote the use of digital tools and urges member states to commit fully to the digitalisation of public services; believes that digitalisation of public services and fully-fledged egovernment capabilities remain essential to eradicate some of the onerous ntbs; recalls , in this regard , that the key provisions of the single digital gateway had to be in force in all eu member states by 12 december 2020; underlines the importance of the ‘digital-by-default’ and ‘once only’ principles , which will save citizens and businesses time and money , in particular if used more widely; welcomes the proposal to add a single market obstacles tool to the single digital gateway;


### 15. reiterates its repeated calls to speed up the implementation and broaden the single digital gateway so as to provide to all users access to comprehensive information on single market rules and administrative procedures through a one-stop-shop; ### 15. regrets that the implementation of the single digital gateway is moving slowly; calls on member states to dedicate sufficient resources to swiftly implementing the single digital gateway in an sme-friendly way by providing user-centered information on single market rules and administrative procedures in order to make it a virtual one-stop shop as far as possible; calls on member states and the commission to extend the scope of the single digital gateway to all business relevant administrative procedures;


### 16. welcomes the commission proposal to make solvit the default tool for single market dispute resolution; ### 16. highlights the potential of making solvit the default tool for single market dispute resolution; notes that despite awareness-raising activities by the commission and member states , solvit is still unknown to many citizens and businesses; stresses that further measures should be taken by the commission and member states to increase its profile; notes that solvit is based on recommendation rather than law and cannot make legally binding decisions; underlines that substantial improvements can be made to solvit’s operations; regrets that some member states fail to ensure adequate and stable staffing , continuity of service and an adequate level of knowledge of eu law in their solvit centres as requested by the commission in its communication com(2017) 255 final; notes that before giving solvit more responsibilities , it must be ensured that member states allocate sufficient resources to it;


### 17. stresses that the international road haulage sector is subject to a number of ntbs restricting access to national markets , which limit its competitiveness , discriminate against transport companies from certain member states and increase emissions; calls on commission and member states to abolish unnecessary restrictions on cabotage , and calls for the opening of the freight and passenger transport services sector within the eu; ### 17. stresses that the international road haulage sector is subject to a number of ntbs restricting access to national markets , which limit its competitiveness , discriminate against transport companies from certain member states and increase emissions; calls on commission and member states to apply restrictions on cabotage only when necessary , and calls for a fair and open freight and passenger transport services sector within the eu;


### 18. welcomes in principle the single market enforcement taskforce (smet) , which aims to assess compliance of national law with single market rules and to prioritise the most pressing barriers; points out that the smet should not just identify problems , but also provide solutions; ### 18. welcomes in principle the single market enforcement taskforce (smet) , which aims to assess compliance of national law with single market rules and to prioritise the most pressing barriers; points out that the smet should not just identify problems , but also provide solutions; calls on commission and member states to ensure the inclusion of stakeholders in the workings of smet;


### 19. recalls that so far the commission’s plan to step up enforcement of eu law by means of the smet has only delivered limited results; calls on the commission to present in due time concrete outcomes of the work of smet , including information on barriers that have been abolished as a result of its actions; ### 19. recalls that so far the commission’s plan to step up enforcement of eu law by means of the smet has only delivered limited results; regrets that smet lacks transparency in its ways of work; calls on commission and member states to ensure that smet publishes lists of participants , agendas and minutes of its meetings on the commission website; notes that the commission in its “long term action plan for better implementation and enforcement of single market rules” (com(2020) 94 final) stated that “the smet will regularly inform the competitiveness council and the european parliament’s internal market and consumer protection committee”; urges on the commission to present concrete outcomes of the work of smet , including information on barriers that have been abolished as a result of its actions , by the end of 2021; calls on commission and member states to publish an annual report about the workings of smet and deliver it to the european parliament’s committee on the internal market and consumer protection and the competitiveness council;


### 25. recalls that the initial response to the pandemic by member states and the commission did not take into account the needs of the single market , and recalls the serious impact this has had on the free cross-border movement of goods and services; ### 25. recalls that the initial response to the pandemic by member states and the commission did not take into account the needs of the single market , and recalls the serious impact this has had on the free cross-border movement of persons , goods and services;


### 26. welcomes the nextgenerationeu recovery package , the eu guidelines for border management , transport green lanes , the eu digital covid certificate to facilitate free movement , and further measures which aim to allow the single market to operate normally; ### 26. welcomes the nextgenerationeu recovery package , the eu guidelines for border management , transport green lanes , the eu digital covid certificate to facilitate free movement , and further measures which aim to allow the single market to operate normally; regrets that some member states have introduced additional travel restrictions such as quarantine for some holders of the digital green certificate; notes that these restrictions are particularly burdensome for cross-border and posted workers;


### (8) to this end , member states should provide the commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. information provided by the member states should include the elements that member states are obliged to report to the world health organization (who) in the context of the international health regulations (ihr)15 . in turn , the commission should report to the european parliament and to the council on the state of play and progress with preparedness , response planning and implementation at union level , including on corrective actions , every 2 years to ensure that national preparedness and response plans are adequate. in order to support the assessment of these plans , eu audits in member states should be conducted , in coordination with the ecdc and union agencies. such planning should include in particular adequate preparedness of critical sectors of society , such as energy , transport , communication or civil protection , which rely , in a crisis situation , on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. in the event of a serious cross-border threat to health originating from a zoonotic infection , it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. ### (8) to this end , member states should provide the commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level , including information on their strategic stockpiles and medical countermeasures available. information provided by the member states should include the elements that member states are obliged to report to the world health organization (who) in the context of the international health regulations (ihr)15 . in turn , the commission should report to the european parliament and to the council on the state of play and progress with preparedness , response planning and implementation at union level , including on corrective actions , every 2 years to ensure that national preparedness and response plans are adequate. in order to support the assessment of these plans , eu audits in member states should be conducted , in coordination with the ecdc and union agencies. such planning should include in particular adequate preparedness of critical long-term healthcare and critical sectors of society , such as energy , transport , communication or civil protection , which rely , in a crisis situation , on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. in the event of a serious cross-border threat to health originating from a zoonotic infection , it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning.


### (12) in case of cross-border health threats due to a communicable disease , the blood and transplant services in the member states can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. these services in return are dependent on rapid risk assessments by the ecdc to safeguard patients , in need of a therapy from a substance of human origin , from a transmission of such communicable disease. such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. the ecdc should therefore set up and operate a network of national blood and transplant services and their authorities to serve this dual purpose. ### (12) in case of cross-border health threats due to a communicable disease , the blood and transplant services , pharmacies and other licensed health care establishments in the member states can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. these services in return are dependent on rapid risk assessments by the ecdc to safeguard patients , in need of a therapy from a substance of human origin , from a transmission of such communicable disease. such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. the ecdc should therefore set up and operate a network of national blood and transplant services and their authorities , as well as pharmacy services and other licensed health services and establishments , to serve this dual purpose.


### 5. the commission may support organising programmes , in cooperation with the member states , for the exchange of healthcare staff and public health staff between two or more member states and for the temporary secondment of staff from one member state to the other. ### 5. the commission may support organising programmes , in cooperation with the member states , for the exchange of healthcare staff and public health staff between two or more member states and for the temporary secondment of staff from one member state to the other. in organising these programmes , account shall be taken of the contribution made by professional health organisations in each of the member states.


### 1. the ecdc shall ensure the further development of the digital platform through which data are managed and automatically exchanged , to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate , for the purpose of supporting communicable disease prevention and control. ### 1. the ecdc shall ensure the further development of the digital platform through which data are managed and automatically exchanged , to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate , and to regularly monitor information on medical countermeasures available in the eu in collaboration with the member states , for the purpose of supporting communicable disease prevention and control.


### (4) trade facilitation , and safety and security , concern all authorities involved in the goods clearance process across union borders. the rapid rise in international trade has increased the need for better cooperation and coordination among those authorities. the ongoing process of digitalisation allows this situation to be addressed more efficiently by connecting the systems of customs and partner competent authorities and enabling a systematic automated exchange of information between them. as such , the current framework of regulatory compliance is insufficient to support an effective interaction between customs and partner competent authorities , whose systems and procedures are characterised by fragmentation and redundancy. a fully coordinated and efficient goods clearance process requires a streamlined union regulatory environment for international trade that delivers long-term benefits to the union and its residents in all policy areas. ### (4) trade facilitation , and safety and security , concern all authorities involved in the goods clearance process across union borders. the rapid rise in international trade has increased the need for better cooperation and coordination among those authorities. the ongoing process of digitalisation allows this situation to be addressed more efficiently by connecting the systems of customs and partner competent authorities and enabling an integrated , accessible and systematic automated exchange of information between them , with the objective of strengthening verification of certificates and establishing regular cooperation on customs procedures. as such , the current framework of regulatory compliance is insufficient to support an effective interaction between customs and partner competent authorities , whose systems and procedures are characterised by fragmentation and redundancy. a fully coordinated and efficient goods clearance process requires a streamlined union regulatory environment for international trade that delivers long-term benefits to the union and its residents in all policy areas , supports the effectiveness and well-functioning of the single market and safeguards consumer protection.


### (6) to achieve a fully digital environment and an efficient goods clearance process for all parties involved in international trade , it is necessary to establish common rules for a harmonised and integrated european union single window environment for customs (eu single window environment for customs). this environment should include a set of fully integrated electronic services delivered at union and national level to facilitate information sharing and digital cooperation between customs and partner competent authorities and to streamline goods clearance processes for economic operators. the eu single window environment for customs should be developed in alignment with the possibilities for trustworthy identification and authentication offered by the eidas regulation37 and the once-only principle where appropriate , as reiterated in the single digital gateway regulation38 . to implement the eu single window environment for customs , it is necessary to establish , on the basis of the pilot project , a certificates exchange system , the eu customs single window certificates exchange system (eu csw-certex) , that interconnects national single window environments for customs and union non-customs systems managing specific non-customs formalities. it is also necessary to harmonise national single window environments for customs , integrate those environments into the eu single window environment for customs , and establish a set of rules on digital administrative cooperation within the eu single window environment for customs. ### (6) to achieve a fully digital environment and an efficient goods clearance process for all parties involved in international trade , it is necessary to establish common rules for a harmonised and integrated european union single window environment for customs (eu single window environment for customs). this environment should include a set of fully integrated electronic services delivered at union and national level to facilitate information sharing and digital cooperation between customs and partner competent authorities and to streamline goods clearance processes for economic operators. the eu single window environment for customs should be developed in alignment with the possibilities for trustworthy identification and authentication offered by the eidas regulation37 and the once-only principle where appropriate , as reiterated in the single digital gateway regulation38 . to implement the eu single window environment for customs , it is necessary to establish , on the basis of the pilot project , a certificates exchange system , the eu customs single window certificates exchange system (eu csw-certex) , that interconnects national single window environments for customs and union non-customs systems managing specific non-customs formalities. it is also necessary to harmonise national single window environments for customs , integrate those environments into the eu single window environment for customs , and establish a set of rules on digital administrative cooperation within the eu single window environment for customs. this regulation should ensure the harmonisation of interfaces between trade systems and the different national single windows , as well as between the national single windows themselves , to provide for technological neutrality that facilitates digital cooperation.


### (6) to achieve a fully digital environment and an efficient goods clearance process for all parties involved in international trade , it is necessary to establish common rules for a harmonised and integrated european union single window environment for customs (eu single window environment for customs). this environment should include a set of fully integrated electronic services delivered at union and national level to facilitate information sharing and digital cooperation between customs and partner competent authorities and to streamline goods clearance processes for economic operators. the eu single window environment for customs should be developed in alignment with the possibilities for trustworthy identification and authentication offered by the eidas regulation37 and the once-only principle where appropriate , as reiterated in the single digital gateway regulation38 . to implement the eu single window environment for customs , it is necessary to establish , on the basis of the pilot project , a certificates exchange system , the eu customs single window certificates exchange system (eu csw-certex) , that interconnects national single window environments for customs and union non-customs systems managing specific non-customs formalities. it is also necessary to harmonise national single window environments for customs , integrate those environments into the eu single window environment for customs , and establish a set of rules on digital administrative cooperation within the eu single window environment for customs. ### (6) to achieve a fully digital environment and an efficient goods clearance process for all parties involved in international trade , it is necessary to establish common rules for a harmonised and integrated european union single window environment for customs (eu single window environment for customs). this environment should include a set of fully integrated electronic services delivered at union and national level to facilitate effective information sharing and digital cooperation between customs and partner competent authorities and to streamline goods clearance processes for economic operators. the eu single window environment for customs should be developed in alignment with the possibilities for trustworthy identification and authentication offered by the eidas regulation37 and the once-only principle where appropriate , as reiterated in the single digital gateway regulation38 . to implement the eu single window environment for customs , it is necessary to establish , on the basis of the pilot project , a certificates exchange system , the eu customs single window certificates exchange system (eu csw-certex) , that interconnects national single window environments for customs and union non-customs systems managing specific non-customs formalities. it is also necessary to harmonise national single window environments for customs , integrate those environments into the eu single window environment for customs , and establish a set of rules on digital administrative cooperation within the eu single window environment for customs.


### (7) the exchanges of digital information through eu csw-certex should cover union non-customs formalities laid down in union legislation that customs authorities are entrusted to enforce. those formalities impose different obligations for the import , export or transit of certain goods , and their verification through customs controls is fundamentally important to the effective functioning of the eu single window environment for customs. eu csw-certex should cover digitalised regulatory formalities laid down in union legislation and managed by partner competent authorities in electronic union non-customs systems , storing the relevant information from all member states required for goods clearance. it is therefore appropriate to identify the union non-customs formalities which should be subject to digital cooperation through eu csw-certex. in particular , eu csw-certex should initially cover sanitary and phytosanitary requirements , rules regulating the import of organic products , environmental requirements in relation to fluorinated greenhouse gases and ozone depleting substances , and formalities related to the import of cultural goods. ### (7) the exchanges of digital information through eu csw-certex should cover union non-customs formalities laid down in union legislation that customs authorities are entrusted to enforce. those formalities impose different obligations for the import , export or transit of certain goods , and their verification through customs controls is fundamentally important to the effective functioning of the eu single window environment for customs. eu csw-certex should cover digitalised regulatory formalities laid down in union legislation and managed by partner competent authorities in electronic union non-customs systems , storing the relevant information from all member states required for goods clearance. it is therefore appropriate to identify the relevant union non-customs formalities which should be subject to digital cooperation through eu csw-certex. in particular , eu csw-certex should initially cover sanitary and phytosanitary requirements , rules regulating the import of organic products , environmental requirements in relation to fluorinated greenhouse gases and ozone depleting substances , and formalities related to the import of cultural goods.


### (8) eu csw-certex should facilitate information sharing between the national single window environments for customs and union non-customs systems. this means that when an economic operator submits a customs declaration requiring the compliance of union non-customs formalities , customs authorities and partner competent authorities may automatically and effectively exchange and verify the required information for the customs clearance process. an improved digital cooperation and coordination between customs authorities and partner competent authorities should lead to more integrated , faster and simpler paperless processes for goods clearance and better enforcement of and compliance with union non-customs formalities. ### (8) eu csw-certex should facilitate information sharing between the national single window environments for customs and union non-customs systems. this means that when an economic operator submits a customs declaration requiring the compliance of union non-customs formalities , customs authorities and partner competent authorities may automatically and effectively exchange and verify the required information for the customs clearance process. an improved digital cooperation and coordination between customs authorities and partner competent authorities should lead to more integrated , faster and simpler paperless processes for goods clearance and better enforcement of and compliance with union non-customs formalities. the configuration , implementation and compliance with the framework for an eu single window environment for customs should also lead to a strengthened control and safeguard mechanisms against fraudulent activities , particularly tax fraud and counterfeit goods.


### (10) any processing of personal data in eu csw-certex should facilitate information sharing between the national environments for customs and union non-customs systems without any storing of data. it should also transform data , where necessary , to enable information exchange between both digital domains. the information technology facilities used for data transformation should be located in the union. ### (10) any processing of personal and non-personal data in eu csw-certex should be without prejudice to the gdpr and other relevant legislation and facilitate information sharing in a safe environment between the national environments for customs and union non-customs systems without any storing of data. it should also transform data , where necessary , to enable information exchange between both digital domains. the information technology facilities used for data transformation should be located in the union.


### (23) close cooperation between the commission and the member states is essential to coordinate all activities associated with the effective functioning of the eu single window environment for customs. given the broad and diverse scope of those activities , it is necessary for each member state to appoint a competent authority as national coordinator. the national coordinator should be the contact point for the commission , and should promote cooperation at national level , while ensuring system interoperability. the commission should provide coordination where necessary , and help ensure the efficient enforcement of union non-customs formalities. ### (23) close cooperation between the commission and the member states is essential to coordinate all activities associated with the effective functioning of the eu single window environment for customs. this will also help to bridge europe’s digital divide , which has become even more apparent during the crisis of the covid-19 pandemic. therefore , the commission should provide appropriate technical and financial support , including training and skills , to members states and relevant authorities to ensure proper implementation of the single windows for customs , with cautious attention to member states’ diverging levels of digitalisation and digital preparedness , thereby preventing potential distortions. given the broad and diverse scope of those activities , it is necessary for each member state to appoint a competent authority as national coordinator. the national coordinator should be the contact point for the commission , and should promote cooperation at national level , while ensuring system interoperability. the commission should provide coordination where necessary , and help ensure the efficient enforcement of union non-customs formalities.


### (25) detailed planning is required to progressively integrate various union non-customs formalities from diverse policy areas into eu csw-certex. to that end , the commission should prepare a work programme to incorporate those formalities into eu csw-certex and to develop connections between the union non-customs systems processing those formalities and eu csw-certex. the main objective of the work programme should be to support the operational requirements and implementation timeline of these activities. the work programme should be reviewed regularly to assess overall progress in applying the provisions of this regulation. ### (25) detailed planning and timelines are required to progressively integrate various union non-customs formalities from diverse policy areas into eu csw-certex. to that end , the commission should prepare a work programme to incorporate those formalities into eu csw-certex and to develop connections between the union non-customs systems processing those formalities and eu csw-certex. the main objective of the work programme should be to support the operational requirements and implementation timeline of these activities. the work programme should be reviewed regularly to assess overall progress in applying the provisions of this regulation.


### (26) the commission should regularly monitor the functioning of the eu single window environment for customs to evaluate the performance of eu csw-certex and to ensure the efficient enforcement of union non-customs formalities covered by eu csw-certex. the commission should submit regular assessment reports on the functioning of the eu single window environment for customs to the european parliament and to the council. those reports should take stock of progress , identify areas for improvement and propose recommendations for the future in light of progress made towards an improved digital collaboration between customs and partner competent authorities involved in goods clearance to ensure simplified processes for economic operators and the efficient enforcement of union non-customs formalities. ### (26) the commission should regularly monitor the functioning of the eu single window environment for customs to evaluate the performance of eu csw-certex and to ensure the efficient enforcement of union non-customs formalities covered by eu csw-certex. the commission should submit regular assessment reports on the functioning of the eu single window environment for customs to the european parliament and to the council. those reports should take stock of progress , identify areas for improvement and in need for investment , indicate measures to be taken by member states' authorities , and propose recommendations for the future in light of progress made towards an improved digital collaboration between customs and partner competent authorities involved in goods clearance to ensure simplified processes for economic operators and the efficient enforcement of union non-customs formalities. for the purpose of monitoring and reporting , the commission should organise and maintain a continuous dialogue with all the relevant economic operators , civil society actors and other relevant parties.


### (27) to ensure an efficient and effective functioning of the eu single window environment for customs , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union (tfeu) should be delegated to the commission in respect of amendments to the list of union non-customs formalities covered by eu csw-certex; specification of the data elements to be exchanged through eu csw-certex and identifying the data elements that are common to both the customs declaration and the application for supporting documents together with the pca data set for each of the relevant union act applicable to union non-customs formalities integrated into eu csw-certex. it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making41 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts. ### (27) to ensure an efficient and effective functioning of the eu single window environment for customs , the power to adopt acts in accordance with article 290 of the treaty on the functioning of the european union (tfeu) should be delegated to the commission to expand the list of union non-customs formalities covered by eu csw-certex; specification of the data elements to be exchanged through eu csw-certex and identifying the data elements that are common to both the customs declaration and the application for supporting documents together with the pca data set for each of the relevant union act applicable to union non-customs formalities integrated into eu csw-certex. it is of particular importance that the commission carry out appropriate consultations during its preparatory work , including at expert level , and that those consultations be conducted in accordance with the principles laid down in the interinstitutional agreement of 13 april 2016 on better law-making41 . in particular , to ensure equal participation in the preparation of delegated acts , the european parliament and the council receive all documents at the same time as member states' experts , and their experts systematically have access to meetings of commission expert groups dealing with the preparation of delegated acts.


### this regulation establishes a european union single window environment for customs that provides an integrated set of interoperable electronic services at union and national level through the european union customs single window certificates exchange system to support interaction and information exchange between the national single window environments for customs and the union non-customs systems referred to in the annex. ### this regulation establishes a european union single window environment for customs that provides an integrated set of harmonised and interoperable electronic services at union and national level through the european union customs single window certificates exchange system to support interaction and enhance information exchange between the national single window environments for customs and the union non-customs systems referred to in the annex.


### it lays down rules for the national single window environments for customs and rules on digital administrative cooperation and information sharing within the european union single window environment for customs. ### it lays down rules for the national single window environments for customs and non-customs formalities and rules on digital administrative cooperation and information sharing within the european union single window environment for customs with the aim of better protecting citizens and reducing administrative burden on economic operators.


### (6) ‘union non-customs system’ means any union electronic system that stores information from all relevant partner competent authorities , which is needed by customs authorities to verify compliance with the respective union non-customs formalities. ### (6) ‘union non-customs system’ means any union electronic system that stores information from all relevant partner competent authorities , which is needed by customs authorities to verify compliance with the respective union non-customs formalities or which is in any case related to border formalities under union law.


### a european union single window environment for customs is hereby established. it shall include the european union customs single window certificates exchange system , national single window environments for customs and the union non-customs systems referred to in the annex. ### a european union single window environment for customs is hereby established. it shall include the european union customs single window certificates exchange system , national single window environments for customs and the union non-customs systems referred to in the annex as well as the union non-customs systems which will be connected to the eu single window environment.


### 4. the commission is empowered to adopt delegated acts in accordance with article 21 amending the annex , in particular to cover other union non-customs formalities. ### 4. the commission is empowered to adopt delegated acts in accordance with article 21 amending the annex , in particular to expand the list of union non-customs formalities covered by eu csw-certex.


### processing of personal data in eu csw-certex ### processing of personal data and non-personal in eu csw-certex


### 2. the national single window environments for customs shall enable the exchange of information and cooperation by electronic means between customs authorities , partner competent authorities and economic operators for the purposes of compliance with and efficient enforcement of customs legislation and the union non-customs formalities listed in the annex. ### 2. the national single window environments for customs shall enable the easy , standardised and interoperable exchange of information and cooperation by electronic means between customs authorities , partner competent authorities and economic operators for the purposes of compliance with and efficient enforcement of customs legislation and the union non-customs formalities listed in the annex.


### provide a single communication channel for economic operators to fulfil the relevant customs formalities and union non-customs formalities subject to additional digital cooperation in accordance with article 12. ### provide a single communication channel for economic operators to easily fulfil the relevant customs formalities and union non-customs formalities subject to additional digital cooperation in accordance with article 12.


### 3. each member state shall notify the commission of any personal data breach that compromises the security , confidentiality , availability or integrity of the personal data processed within its single window environment for customs. ### 3. each member state shall notify the commission of any personal data breach or economic operator's data breach that compromises the security , confidentiality , availability or integrity of the personal data processed within its single window environment for customs.


### 1. for each of the union non-customs formalities listed in the annex , eu csw-certex shall enable information to be exchanged between the national single window environments for customs and the relevant union non-customs systems for the following purposes: ### 1. for each of the union non-customs formalities listed in the annex , eu csw-certex shall enable information to be effectively exchanged between the national single window environments for customs and the relevant union non-customs systems for the following purposes:


### allowing economic operators to submit the relevant information required for the fulfilment of the applicable customs formalities and union non-customs formalities; ### allowing economic operators to easily submit the relevant information required for the fulfilment of the applicable customs formalities and union non-customs formalities;


### the commission shall , by means of implementing acts , adopt a work programme to support the implementation of the provisions of this regulation related to the connection of the union non-customs systems referred to in the annex to eu csw-certex and the integration of the respective union non-customs formalities. the work programme shall be kept up to date. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 22(2). ### the commission shall , by means of implementing acts , adopt a work programme to support the implementation of the provisions of this regulation related to the connection of the union non-customs systems referred to in the annex to eu csw-certex and the integration of the respective union non-customs formalities. the work programme shall be kept regularly up to date. those implementing acts shall be adopted in accordance with the advisory procedure referred to in article 22(2).


### 3. by 31 december 2027 and every three years thereafter , the commission shall submit to the european parliament and to the council a report on the implementation of this regulation. the report shall also include information on the monitoring and evaluation carried out in accordance with paragraphs 1 and 2 , respectively. ### 3. by 31 december 2026 and every three years thereafter , the commission shall submit to the european parliament and to the council a report on the implementation across member states of this regulation. the report shall also include information on the monitoring and evaluation carried out in accordance with paragraphs 1 and 2 , respectively.


### article 8(3) , point (c) , article 11 , article 13(1) , (2) and (3) , article 14 and article 15(1) and (2) shall apply from 1 january 2031. ### article 8(3) , point (c) , article 11 , article 13(1) , (2) and (3) , article 14 and article 15(1) and (2) shall apply from 1 january 2029.


### (1) council directive 2008/114/ec17 provides for a procedure for designating european critical infrastructures in the energy and transport sectors , the disruption or destruction of which would have significant cross-border impact on at least two member states. that directive focused exclusively on the protection of such infrastructures. however , the evaluation of directive 2008/114/ec conducted in 201918 found that due to the increasingly interconnected and cross-border nature of operations using critical infrastructure , protective measures relating to individual assets alone are insufficient to prevent all disruptions from taking place. therefore , it is necessary to shift the approach towards ensuring the resilience of critical entities , that is , their ability to mitigate , absorb , accommodate to and recover from incidents that have the potential to disrupt the operations of the critical entity. ### (1) council directive 2008/114/ec17 provides for a procedure for designating european critical infrastructures in the energy and transport sectors , the disruption or destruction of which would have significant cross-border impact on at least two member states. that directive focused exclusively on the protection of such infrastructures. however , the evaluation of directive 2008/114/ec conducted in 201918 found that due to the increasingly interconnected and cross-border nature of operations using critical infrastructure , protective measures relating to individual assets alone are insufficient to prevent all disruptions from taking place. therefore , it is necessary to shift the approach towards ensuring the resilience of critical entities , that is , their ability to mitigate , absorb , accommodate to and recover from incidents that have the potential to disrupt the operations of the critical entity and the functioning of the internal market.


### (1) council directive 2008/114/ec17 provides for a procedure for designating european critical infrastructures in the energy and transport sectors , the disruption or destruction of which would have significant cross-border impact on at least two member states. that directive focused exclusively on the protection of such infrastructures. however , the evaluation of directive 2008/114/ec conducted in 201918 found that due to the increasingly interconnected and cross-border nature of operations using critical infrastructure , protective measures relating to individual assets alone are insufficient to prevent all disruptions from taking place. therefore , it is necessary to shift the approach towards ensuring the resilience of critical entities , that is , their ability to mitigate , absorb , accommodate to and recover from incidents that have the potential to disrupt the operations of the critical entity. ### (1) council directive 2008/114/ec17 provides for a procedure for designating european critical infrastructures in the energy and transport sectors , the disruption or destruction of which would have significant cross-border impact on at least two member states. that directive focused exclusively on the protection of such infrastructures. however , the evaluation of directive 2008/114/ec conducted in 201918 found that due to the increasingly interconnected and cross-border nature of operations using critical infrastructure such as high speed rail or air traffic management , protective measures relating to individual assets alone are insufficient to prevent all disruptions from taking place. therefore , it is necessary to shift the approach towards ensuring the resilience of critical entities , that is , their ability to mitigate , absorb , accommodate to and recover from incidents that have the potential to disrupt the operations of the critical entity and the functioning of the internal market.


### (2) despite existing measures at union19 and national level aimed at supporting the protection of critical infrastructures in the union , the entities operating those infrastructures are not adequately equipped to address current and anticipated future risks to their operations that may result in disruptions of the provision of services that are essential for the performance of vital societal functions or economic activities. this is due to a dynamic threat landscape with an evolving terrorist threat and growing interdependencies between infrastructures and sectors , as well as an increased physical risk due to natural disasters and climate change , which increases the frequency and scale of extreme weather events and brings long-term changes in average climate that can reduce the capacity and efficiency of certain infrastructure types if resilience or climate adaptation measures are not in place. moreover , relevant sectors and types of entities are not recognised consistently as critical in all member states. ### (2) despite existing measures at union19 and national level aimed at supporting the protection of critical infrastructures in the union , the entities operating those infrastructures are not adequately equipped to address current and anticipated future risks to their operations that may result in disruptions of the provision of services that are essential for the performance of vital societal functions or economic activities. this is due to a dynamic threat landscape with an evolving terrorist threat and growing interdependencies between infrastructures and sectors , as well as an increased physical risk due to natural disasters and climate change , which increases the frequency and scale of extreme weather events and brings long-term changes in average climate that can reduce the capacity and efficiency of certain infrastructure types if resilience or climate adaptation measures are not in place. moreover , relevant sectors such as certain transport and tourism sectors , and types of entities are not recognised consistently as critical in all member states.


### (2) despite existing measures at union19 and national level aimed at supporting the protection of critical infrastructures in the union , the entities operating those infrastructures are not adequately equipped to address current and anticipated future risks to their operations that may result in disruptions of the provision of services that are essential for the performance of vital societal functions or economic activities. this is due to a dynamic threat landscape with an evolving terrorist threat and growing interdependencies between infrastructures and sectors , as well as an increased physical risk due to natural disasters and climate change , which increases the frequency and scale of extreme weather events and brings long-term changes in average climate that can reduce the capacity and efficiency of certain infrastructure types if resilience or climate adaptation measures are not in place. moreover , relevant sectors and types of entities are not recognised consistently as critical in all member states. ### (2) despite existing measures at union19 and national level aimed at supporting the protection of critical infrastructures in the union , the entities operating those infrastructures are not adequately equipped to address current and anticipated future risks to their operations that may result in disruptions of the provision of services that are essential for the performance of vital societal functions or economic activities. this is due to a dynamic threat landscape with hybrid threats , emerging technologies , in particular artificial intelligence , an evolving terrorist threat and growing interdependencies between infrastructures and sectors , as well as an increased physical risk due to natural disasters and climate change , which increases the frequency and scale of extreme weather events and brings long-term changes in average climate that can reduce the capacity and efficiency of certain infrastructure types if resilience or climate adaptation measures are not in place. moreover , relevant sectors and types of entities are not recognised consistently as critical in all member states.


### (4) the entities involved in the provision of essential services are increasingly subject to diverging requirements imposed under the laws of the member states. the fact that some member states have less stringent security requirements on these entities not only risks impacting negatively on the maintenance of vital societal functions or economic activities across the union , it also leads to obstacles to the proper functioning of the internal market. similar types of entities are considered as critical in some member states but not in others , and those which are identified as critical are subject to divergent requirements in different member states. this results in additional and unnecessary administrative burdens for companies operating across borders , notably for companies active in member states with more stringent requirements. ### (4) the entities involved in the provision of essential services are increasingly subject to diverging requirements imposed under the laws of the member states. the fact that some member states have less stringent security requirements on these entities not only creates heterogeneous levels of resilience across member states impacting negatively on the maintenance of vital societal functions or economic activities across the union , it also leads to obstacles to a level playing field and the proper functioning of the internal market. similar types of entities are considered as critical in some member states but not in others , and those which are identified as critical are subject to divergent requirements in different member states. this results in additional and unnecessary administrative burdens for companies operating across borders , notably for companies active in member states with more stringent requirements.