(1)

Microplastics are ubiquitous, persistent and transboundary. They are detrimental to the environment and potentially harmful to human health , particularly due to the presence of harmful chemical additives and other substances of concern added during production and conversion, such as phthalates, bisphenol A, or flame retardants (3) . Microplastics are easily transported through the air and by land surface waters and ocean currents, and their mobility is an aggravating factor. They are found in soil (including agricultural lands), lakes, rivers, estuaries, beaches, lagoons, seas, oceans and in remote, once pristine regions, and their presence in soil may have effects on soil properties and trigger soil alterations which negatively impact the growth of some plants. Impacts of microplastics on the marine environment have been extensively documented. Once in the marine environment, microplastics are nearly impossible to collect, and are known to be eaten by a range of organisms and animals and cause harm to biodiversity and ecosystems. The persistence of a plastic pellet in the aquatic environment may be measured over decades or more, and ingestion of plastic pellets by marine wildlife, notably seabirds and sea turtles, may cause physical harm or death. Microplastics also contribute to climate change as an additional source both of greenhouse gas emissions and of pressure on ecosystems. Microplastics’ potential to act as a carrier for adsorbed toxicants or pathogenic microorganisms is an integral part of the problem. Humans are exposed to microplastics via air and food consumption. The growing awareness of microplastics’ presence in the food chain can undermine consumer confidence and bear economic consequences. There may be negative economic impacts on activities such as commercial fishing and agriculture as well as recreation and tourism in areas affected by the releases. [Am. 1]

(2)

In their opinion entitled ‘Environmental and health risks of microplastic pollution’, the Commission’s Group of Chief Scientific Advisors considered that ‘there are significant grounds for concern and for precautionary measures to be taken’ (4).

(3)

Plastic pellet losses constitute the third largest source of microplastics unintentionally released to the environment in the Union and are due to poor handling practices at all stages of the supply chain, including production, processing, distribution, transport, including by sea, and other logistic operations. Hence, a supply chain approach is essential for ensuring the commitment of all economic actors involved in plastic pellet handling towards loss prevention. Since 2015, the European plastic manufacturing industry has progressively adopted the international Operation Clean Sweep® programme (OCS) as a voluntary pledge. Under this programme, each company making or handling pellets recognises the importance of making zero pellet losses and commits to adopting best practices. While such practices are generally well understood by OCS signatories, they have not been comprehensively implemented. The uptake of the programme by the plastic industry remains low.

(4)

The impacts of microplastic pollution on the environment and possibly on human health have raised concerns in most parts of the world. Some Member States have adopted or proposed dedicated measures. However, a patchwork of national restrictions could potentially hamper the functioning of the internal market. [Am. 2]

(5)

In a bid to tackle plastic pollution, in January 2018, the Commission adopted a Communication entitled ‘European Strategy for Plastics’ (5) where it acknowledged the risks posed by microplastics and called for innovative solutions targeting the different sources of microplastics to be taken. This commitment was renewed with the adoption of the European Green Deal in December 2019, the new Circular Economy Action Plan (6) in March 2020 and the Zero Pollution Action Plan (7) in May 2021. The latter includes, among its 2030 targets, reducing the amount of microplastics released into the environment by 30 %.

(6)

Commission Regulation (EU) 2023/2055 (8) addresses microplastic pollution by imposing a restriction on the placing on the market of microplastics that are intentionally added to products (the ‘restriction’), as there is considerable microplastic pollution arising from the use of synthetic polymer microparticles on their own or intentionally present in products, and pollution poses an unacceptable risk to the environment.

(7)

In 2021, the parties to the Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR) adopted the non-binding Recommendation 2021/06 (9) to reduce the loss of plastic pellets into the marine environment by promoting the timely development and implementation of effective and consistent pellet loss prevention standards and certification schemes for the entire plastic supply chain. Measures for minimizing the risk associated with the transport of plastic pellets by sea are under examination at the International Maritime Organization (IMO) in light of the significant risk of catastrophic pollution associated with maritime transport of plastic pellets . In this context, the Union should follow closely the developments at the IMO, and play a leading role in ensuring a high-level of environmental protection on this issue. [Am. 3]

(7a)

Several accidents leading to plastic pellet spills and losses have been registered in the Union with transboundary impacts, highlighting the urgent need for ambitious, holistic measures to significantly reduce the risk of plastic pellet pollution while strengthening response capabilities in relation to plastic pellet spills throughout Union territories and waters. [Am. 4]

(7b)

Nearly 90 % of the world's goods are transported by sea, including plastic pellets. However, poor handling practices or a lack of supervision of certain routine operations, such as cleaning hulls or containers, can lead to such pellets leaking out and spilling into the ocean. Furthermore, many maritime pellet disasters have been reported, making maritime transport a high-risk activity in relation to plastic pellet pollution. The impact of such pellet losses is catastrophic for marine and coastal ecosystems as well as the species that comprise them, and the extreme mobility of plastic pellets makes effective containment and clean-up operations difficult. The handling of such pellets is regulated at international level by the 1972 Convention for Safe Containers, and supplemented by the 2023 Sub-Committee on Carriage of Cargoes and Containers circular on the obligation to report lost containers, but they do not provide the guarantees needed to prevent pollution by plastic pellets. The inclusion of maritime transport in the scope of this Regulation, as well as of provisions relating to the handling of plastic pellets specific to this mode of transport, is therefore essential if the objectives of this Regulation are to be achieved. [Am. 5]

(8)

In the Union submission to United Nations Environment Programme in view of the second session of the Intergovernmental Negotiating Committee on an international legally binding instrument on plastic pollution (INC-2) (10), the Union and its Member States stressed the need for the future instrument to include measures to reduce unintentional releases of microplastics.

(9)

Despite Union legislation concerning the prevention of waste, pollution, marine litter and chemicals, there are no specific Union rules preventing pellet losses as a source of microplastic pollution along the entire supply chain. Directive 2008/98/EC of the European Parliament and of the Council (11) lays down basic waste management principles and imposes general obligations for Member States to take measures to prevent waste generation. Those general obligations should be complemented by addressing specific aspects and requirements for the careful handling of plastic pellets in order to avoid them becoming waste prevent them from escaping into the environment . [Am. 6]

(9a)

This Regulation provides for measures to prevent, contain and clean up plastic pellet pollution occurring following the entry into force of this Regulation, but does not provide for measures to address existing pollution. Cleaning up soil, rivers and streams, and restoring degraded terrestrial, marine, littoral and coastal ecosystems is essential to achieving the 30 % reduction target by 2030, in accordance with the objectives set out in Regulation (EU) 2024/1991 of the European Parliament and of the Council (12), and the objectives of the European Green Deal. The Commission should develop a set of measures to map and clean up those already polluted areas, and implement them either as part of a European strategy for depolluting microplastics, or through support and accompanying measures for Member States. More broadly, the Union should be involved in promoting solutions along the entire value chain, and should include such solutions in the ongoing negotiations on the development of an international Treaty on Plastic Pollution, as well as in the upcoming 81st session of the Marine Environment Protection Committee of the IMO (IMO MEPC). [Am. 7]

(10)

While the production of polymeric materials on an industrial scale fall under the scope of Directive 2010/75/EU of the European Parliament and of the Council (13), other activities like the conversion, transport or storage of pellets, usually operated by small and medium-sized enterprises, are not covered by that Directive. Moreover, the Reference Document on Best Available Techniques in the Production of Polymers of August 2007 (14), established pursuant Council Directive 96/61/EC (15) concerning integrated pollution prevention and control, does not address the specific issue of pellet losses.

(11)

Directive 2008/56/EC of the European Parliament and of the Council (16) addresses the monitoring and assessment of the impacts of microlitter, including microplastics, in coastal and marine environments. An update of the first guidance on monitoring marine litter is under development in view of harmonised methodologies including to monitor the presence and distribution of plastic pellets along the coastline. However, Directive 2008/56/EC does not include specific requirements concerning the prevention or reduction of pellet losses at source.

(12)

Commission Regulation (EU) 2023/2055 addresses losses of synthetic polymer microparticles for use at industrial sites i.e. plastic pellets as avoidable releases. For these releases, a reporting requirement for an estimated quantity of microplastics released to the environment on an annual basis is introduced. While lacking However, that reporting requirement lacks a methodology to estimate losses, and only provides annual estimates. While this requirement will increase information on pellet losses and improve the quality of the information collected to assess the risks deriving from these microplastics in the future , it is not sufficient to have an overview of the specific nature of the losses and the causes thereof . [Am. 8]

(13)

To ensure that plastic pellets are handled safely and responsibly at all stages of the supply chain, so that losses to the environment are prevented, it is necessary to establish requirements on the handling of plastic pellets along the entire supply chain: production, master batching and compounding, conversion, waste management, including recycling, distribution, repacking, transport, storage and tank cleaning at cleaning stations.

(14)

Such requirements should take into account internationally recommended good handling practices as well as existing requirements on the handling of plastic pellets established by the industry in the Union.

(15)

Economic operators, EU carriers and non-EU carriers should implement the requirements on the handling of plastic pellets by following a priority order of action with the paramount goal of preventing the release of pellets in the environment as the top priority. Therefore, preventing spills of plastic pellets from primary containment during routine handling, thus reducing the risk of spills to the lowest possible level, should be the first step, including by avoiding any unnecessary handling (for instance by reducing the transfer points) and by labelling all storage and transport containers containing plastic pellets as well as by using puncture-proof appropriate packaging, followed by containment of spilled pellets to make sure they do not become a loss to the environment, and eventually by clean up after a spill or loss event as the final step. [Am. 9]

(16)

While the aim is to prevent achieve zero plastic pellet losses to the environment for all economic operators, EU carriers and non-EU carriers, obligations for micro-, small and medium-sized enterprises and enterprises that handle under 1 000 tonnes of plastic pellets annually should be adjusted to mitigate the burden on them. [Am. 10]

(17)

The registration of installations handling plastic pellets and of carriers transporting them is necessary for the traceability of plastic pellets handled and transported in each Member State and to allow competent authorities to perform compliance checks efficiently.

(18)

In order to prevent plastic pellet losses and to achieve zero plastic pellet losses, economic operators should establish, implement, and update at all times a risk assessment plan identifying potential for spills and losses and documenting in particular specific equipment and procedures in place to prevent, contain and clean up pellet losses, taking into consideration the installation size and the scale of operations. [Am. 11]

(19)

To enable competent authorities to verify compliance with the risk assessment plan’s requirements, economic operators should provide the competent authority with the risk assessment plan they have conducted, together with a self-declaration of conformity.

(20)

Economic operators should be able to choose put in place the specific equipment to install or the procedure procedures to execute. Nevertheless, competent authorities, while verifying compliance, should be able to require economic operators to amend the risk assessment plan including by taking, in a given timeframe, any of the actions listed in this Regulation to ensure adequate implementation of the requirements of this Regulation. Economic operators should be able to be exempted from installing certain types of equipment or from adopting certain measures if they duly justify such exemptions to the competent authorities, taking into account the nature and size of the installation and the scale of its operations. Micro enterprises should consider at least the specific equipment to be installed or the procedures to be executed, taking into account the nature and size of the installation as well as the scale of its operations. [Am. 12]

(21)

In order to evaluate the adequacy of the risk assessment plan carried out for each installation, economic operators should keep record of an estimate of the quantity of the pellets released to the environment per year, together with the total volume handled. To reduce burden on economic operators, the information on estimates of quantities released may be used in the framework of the reporting requirement under Commission Regulation (EU) 2023/2055.

(22)

Due to the characteristics of their activity, carriers should not be mandated to conduct a risk assessment plan. Instead, they should be required to undertake tangible measures aimed at preventing, containing, and addressing spills and losses. These measures should be subject to verification by competent authorities, primarily during the transportation process.

(23)

The successful implementation of the actions required to prevent plastic pellet losses and to achieve zero plastic pellet losses requires the full cooperation and commitment of economic operators’, EU carriers’ and non-EU carriers’ employees. Economic operators and EU carriers should be required to train their staff according to their employees’ specific roles and responsibilities in order to ensure they are aware of and are able to use the equipment and execute the procedures necessary to ensure compliance with the requirements laid down in this Regulation. Economic operators and EU carriers should also be required to monitor and keep records of the relevant actions to implement the requirements set out in this Regulation, for instance, the placement of new catchment devices. Where appropriate, they should adopt corrective actions including, where necessary, the improvement of equipment and procedures in place. [Am. 13]

(24)

Small, medium and large-sized enterprises that operate installations where plastic pellets are handled in quantities above 1 000 tonnes may bring higher risks of pellet losses to the environment. For this reason, these enterprises should be required to implement, for each installation, extra actions like carrying out an annual internal assessment, and adopting a mandatory training programme addressing specific training needs and modalities issues in relation to prevention, practices, workers protection, clean-up technologies, use and maintenance of equipment, the execution of procedures, as well as the monitoring and reporting of plastic pellet losses . In addition, for these enterprises, compliance with the requirements laid down in this Regulation should be demonstrated by obtaining, and renewing, a certificate issued by certifiers. These certifiers can either be an accredited conformity assessment body, or an environmental verifier licenced to carry out verification and validation in accordance with Regulation (EC) No 1221/2009 of the European Parliament and of the Council (17) on the voluntary participation by organisations in a Community eco-management and audit scheme (EMAS). The certificate should correspond to a unique format in order to ensure homogeneous information. Small enterprises operating installations where plastic pellets in quantities above 1 000 tonnes have been handled should obtain certification only once. Such certification should be valid for 5 years after which they should notify an update of their risk assessment plan as well as a self-declaration of conformity every 5 years. [Am. 14]

(25)

Micro and small-sized enterprises Small , and medium and large-sized enterprises operating installations where plastic pellets in quantities below 1 000 tonnes have been handled and micro enterprises should be required to be subject to a self-declaration of conformity. They should also be given sufficient time to demonstrate their compliance. [Am. 15]

(26)

To enable competent authorities to more efficiently verify compliance under this Regulation, certifiers should notify competent authorities about the outcome of their assessments. Certificates should not prejudge the assessment on compliance by competent authorities.

(27)

In order to be EMAS registered, economic operators are required to comply with environmental legislation, including this Regulation. Consequently, economic operators which are registered to EMAS should be considered compliant with the requirements laid down in this Regulation provided that an environmental verifier has verified that requirements laid down in this Regulation have been included in their environmental management system and implemented. These economic operators should therefore be exempted from the obligations of certification and notification to competent authorities when renewing self-declarations and risk assessments.

(28)

Competent authorities should verify economic operators’, EU carriers’ and non-EU carriers’ compliance with the obligations arising from this Regulation using, if appropriate, the findings provided as part of the certification or as self-declarations, based on either environmental inspections or other verification measures, on a risk-based approach. Inspections should, where possible, be coordinated with those required under other Union legislation. Competent authorities should provide the Commission with information on the implementation of this Regulation.

(29)

In order to minimise the effects of any loss, the economic operator, EU carrier and non-EU carrier should take the measures necessary to restore compliance. The corrective action required should be proportionate to the infringement detected and its expected harmful effects on the environment. Where competent authorities detect an infringement of this Regulation, they should notify the economic operator, the EU carrier or the non-EU carrier about the infringement detected and require that corrective measures are taken to restore compliance.

(30)

Competent authorities should have a minimum set of inspection and enforcement powers in order to ensure compliance with this Regulation, to cooperate with each other more quickly and more efficiently, and to deter economic operators, EU carriers and non-EU carriers from infringing this Regulation. Those powers should be sufficient to tackle the enforcement challenges and to prevent non-compliant economic operators from exploiting gaps in the enforcement system by relocating to Member States whose competent authorities are not equipped to tackle unlawful practices.

(31)

Competent authorities should be able to use all facts and circumstances of the case as evidence for the purpose of their inspection.

(32)

As micro, small and medium-sized enterprises (SMEs) in account for an important share of the pellet supply chain , they should comply with the relevant obligations laid down in this Regulation, however they could face while taking into consideration the possible different challenges linked to that compliance and the possible proportionally higher costs and difficulties when complying with some of the obligations. The Commission and the competent authorities should raise awareness among economic operators and carriers regarding the necessity of preventing pellet losses. Additionally, the Commission and the competent authorities should develop training materials , in consultation with all relevant stakeholders, to assist them economic operators and carriers in fulfilling their obligations, particularly with respect to the requirements of the risk assessment . That should be done by taking into account the non-binding Recommendation adopted by the parties to the Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR) . Member States should provide access to information and assistance regarding compliance with obligations and the risk assessment requirements. Regarding the assistance of Member States, this could include technical and financial support as well as and specialised training to SMEs all personnel handling plastic pellets, as well as financial support and access to finance for micro and small enterprises as well as for installations handling plastic pellets in smaller quantities . Member States actions should be taken in respect of applicable State aid rules. [Am. 16]

(33)

In order to facilitate common grounds to estimate the losses of plastic pellets to the environment, it is necessary to have a standardised methodology set in a harmonised standard that is adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council (18). Pending the adoption of the standardised methodology, economic operators should indicate the methodology used when reporting losses of plastic pellets. [Am. 17]

(34)

Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements set out in this Regulation.

(35)

In order to ensure that the objectives of this Regulation are achieved, and the requirements are enforced effectively, Member States should designate their own competent authorities responsible for the application and enforcement of this Regulation. In cases where there is more than one designated competent authority in their territory, in order to ensure effective exercise of the duties of the competent authorities, Member States should ensure close cooperation between all designated competent authorities.

(36)

In order to ensure compliance, competent authorities should also take the necessary steps, including inspections and hearings when in possession of and based on relevant information, including substantiated complaints submitted by third parties. Third parties submitting a complaint should be able to demonstrate a sufficient interest or maintain the impairment of a right.

(37)

Member States should ensure that any measures taken by their competent authorities under this Regulation are subject to effective judicial remedies in accordance with Article 47 of the Charter of Fundamental Rights of the European Union (19). According to settled case law of the Court of Justice of the European Union, it is for the courts of the Member States to ensure judicial protection of a person’s rights under Union law. Furthermore, Article 19(1) of the Treaty on European Union requires Member States to provide remedies that are sufficient to ensure effective judicial protection in the fields covered by Union law. In this respect, Member States should ensure that the public, including natural or legal persons in accordance with this Regulation, has access to justice in line with the obligations that Member States have agreed to as parties to the UN Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters of 25 June 1998 (the ‘Aarhus Convention’) (20).

(38)

In order to ensure that economic operators are effectively dissuaded from non-compliance with the requirements laid down in this Regulation, Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that those rules are implemented. The penalties provided should be effective, proportionate and dissuasive. To facilitate a more consistent application of penalties, it is necessary to establish common criteria for determining the types and levels of penalties to be imposed in case of infringement. Those criteria should include, inter alia, the nature and gravity of the infringement as well as the economic benefits derived from the infringement in order to ensure that those responsible are deprived of those benefits. Member States should endeavour to ensure that the revenue generated from the penalties, or its equivalent financial value, is used to support projects aimed at cleaning up areas polluted by plastic and avoiding plastic pellet pollution. [Am. 18]

(39)

When setting penalties and measures for infringements, the Member States should foresee that, based on the gravity of the infringement, the level of fines should effectively deprive the non-compliant economic operator, EU carriers and non-EU carriers from the economic benefit derived from non-compliance with the obligations deriving from this Regulation, including in cases of repeated infringements. The gravity of the infringement should be the leading criterion for the measures taken by the enforcement authorities. The maximum amount of fines should, in case of an infringement committed by a legal person, represent at least 4 % 3 % of the economic annual turnover in the Member State concerned Union . [Am. 19]

(40)

Where damage to human health has occurred as a result of an infringement of this Regulation, Member States should ensure that the individuals affected are able to claim and obtain compensation for that damage from the relevant natural or legal persons and, where appropriate, from the relevant competent authorities responsible for the infringement. Such rules on compensation contribute to pursuing the objectives of preserving, protecting and improving the quality of the environment and protecting human health as laid down in Article 191 of the Treaty on the Functioning of the European Union. They also underpin the right to life, integrity of the person and health care laid down in Articles 2, 3 and 35 of the Charter of Fundamental Rights of the European Union and the right to an effective remedy as laid down in Article 47 of the Charter. Moreover, Directive 2004/35/EC of the European Parliament and of the Council (21) does not give private parties a right of compensation as a consequence of environmental damage or of an imminent threat of such damage.

(41)

To ensure that individuals can defend their rights against damages to health caused by infringements of this Regulation and thereby ensure its more efficient enforcement, non-governmental organisations promoting the protection of human health or the environment, including those promoting the protection of consumers and meeting any requirements under national law, as members of the public concerned, should be empowered to engage in proceedings, as the Member States so determine, either on behalf or in support of any victim, without prejudice to national rules of procedure concerning representation and defence before the courts. Member States usually enjoy procedural autonomy to ensure an effective remedy against violations of Union law, subject to the respect of the principles of equivalence and effectivity. However, experience shows that while there is overwhelming epidemiologic evidence on the negative health impacts of pollution on the population, in particular as regards air, it is difficult for the victims under the procedural rules on the burden of proof generally applicable in the Member States to demonstrate a causality link between the suffered harm and the violation. Therefore, it is necessary to adapt the burden of proof applicable to such situations. When an individual can provide sufficiently robust evidence to give rise to a presumption that the violation of this Regulation is at the origins of the damage caused to the health of an individual, or has significantly contributed to it, it should be for the defendant to rebut that presumption in order to escape his liability.

(42)

In order to take into account technical progress and scientific developments, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the Annexes. 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-Making (22). 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.

(43)

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of reporting of information on the implementation of this Regulation.

(44)

In order to provide economic operators, EU carriers, and non-EU carriers with sufficient time to adapt to the requirements laid down in this Regulation, its application should be deferred.

(a)

‘plastic pellet’ means a small mass of preformed polymer-containing moulding material, having relatively uniform dimensions in a given lot regardless of its shape or form, including powders, cylinders, beads and flakes, to which additives might have been added , that is used as feedstock in plastic product manufacturing and plastic recycling operations; [Am. 21]

(aa)

'plastic pellet dust' means the industrial residue from the handling, grinding or processing of plastic pellets, that is not used as feedstock in plastic product manufacturing operations; [Am. 22]

(b)

‘spill’ means a one-off or prolonged escape of plastic pellets from primary containment; [Am. 23]

(c)

‘loss’ means a one-off or prolonged escape of plastic pellets at any stage of the supply chain, including from the installation’s boundary to the environment or from road vehicles, rail wagons or inland waterway vessels transporting the transport of plastic pellets; [Am. 24]

(d)

‘installation’ means any premises, structure, environment site or place within which one or more economic activities involving the handling of plastic pellets are carried out; [Am. 25]

(e)

‘economic operator’ means any natural or legal person who operates or controls in whole or in part the installation, or, where this is provided for in national law, to whom decisive economic power over the technical functioning of the installation has been delegated;

(f)

‘EU carrier’ means any natural or legal person established in a Member State, engaged in the transport of plastic pellets as part of its economic activity by using road vehicles, rail wagons or inland waterway vessels; [Am. 26]

(g)

‘non-EU carrier’ means any natural or legal person established in a third country, engaged in the transport of plastic pellets as part of its economic activity in the Union by using road vehicles, rail wagons or inland waterway vessels; [Am. 27]

(h)

‘micro, small or medium-sized enterprise’ means a micro, small or medium-sized enterprise within the meaning of the Annex to Commission Recommendation 2003/361/EC (23);

(i)

‘large-sized enterprise’ means an enterprise that is not a micro, small or medium-sized enterprise;

(j)

‘competent authority’ means an authority or a body designated by a Member State to carry out its obligations under this Regulation;

(k)

‘certifier’ means any of the following:

(l)

‘conformity assessment’ means the process demonstrating whether an installation fulfils the applicable rules of this Regulation and of the delegated acts adopted on the basis thereof;

(a)

the certifier shall be independent of the economic operator;

(b)

the certifier, its top-level management and the personnel responsible for the conformity assessment shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to the certification activities;

(c)

the certifier and its personnel shall carry out their activities with the highest degree of professional integrity and the requisite technical competence and shall be free from all pressures and inducements, including financial, which might influence their judgement or the results of their certification activities;

(d)

the certifier shall have the expertise, equipment and infrastructure required to perform the conformity assessment in relation to which it has been accredited;

(e)

the certifier shall have a sufficient number of suitably qualified and experienced personnel responsible for carrying out the conformity assessment tasks;

(f)

the personnel of a certifier shall observe professional secrecy with regard to all information obtained in carrying out the conformity assessment tasks;

(g)

where a certifier subcontracts specific tasks connected with certification or has recourse to a subsidiary, it shall take full responsibility for the tasks performed by subcontractors or subsidiaries and shall assess and monitor the qualifications of the subcontractor or the subsidiary and the work carried out by them.

(a)

the experience gained from the implementation of obligations set out in Articles 3, 4, 5, 8 and 9 4 and 5; [Am. 72]

(b)

relevant international standards;

(c)

the specificities of the sectors of activity;

(d)

the specific needs of micro, small and medium-sized enterprises.

(a)

the technical feasibility of introducing a unique and differentiable, chemical signature which is not harmful to the environment or human health;

(b)

setting up a Union database of all chemical signatures.