(1)

Entry 50 of Annex XVII to Regulation (EC) No 1907/2006 contains restrictions with respect to eight polycyclic-aromatic hydrocarbons (PAHs) (2).

(2)

Rubber granules are used as infill material in synthetic turf pitches. Rubber granules and mulches are also used in loose form on playgrounds or in sport applications, such as golf courses, athletic arenas, horse arena footings, nature trails, or shooting ranges. Those granules and mulches originate predominantly from End of Life Tyres (ELT). One of the main concerns over the use of ELT granules and mulches is the presence of the eight PAHs in the rubber matrix. Granules and mulches are mixtures within the meaning of Article 3(2) of Regulation (EC) No 1907/2006 and hence are not covered by the existing entry 50 of Annex XVII to that Regulation. However, the eight PAHs are listed as carcinogenic category 1B in Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3). Therefore, entry 28 of Annex XVII to Regulation (EC) No 1907/2006 restricts the supply of granules and mulches to the general public, if those mixtures contain PAHs at concentrations equal to or above 100 mg/kg for BaP or DBAhA, or 1 000 mg/kg for the other six PAHs.

(3)

To perform the risk characterisation of the granules or mulches containing the eight PAHs, the concentration limits of the individual PAHs in entry 28 of Annex XVII to Regulation (EC) No 1907/2006 cannot simply be summed up. By applying an additivity approach in accordance with the Guidance on the application of Regulation (EC) No 1272/2008 (4) and taking into account the relative contribution of the different PAHs to the PAH content in rubber granules and mulches, the maximum concentration limit for the sum of the eight listed PAHs can be calculated and is approximately 387 mg/kg (5). The Rijksinstituut voor Volksgezondheid en Milieu (RIVM) (6) and the European Chemicals Agency (hereinafter ‘the Agency’) (7) concluded in 2017 that this calculated concentration limit for mixtures of the eight PAHs is too high to guarantee safe supply and use of these granules in synthetic turf pitches. In its evaluation, the Agency recommended lowering the concentration limit of the eight PAHs in granules used in synthetic turf pitches through a restriction under Regulation (EC) No 1907/2006 because the current concentration limits were considered too high to provide adequate protection for human health.

(4)

Based on those conclusions and evaluations, on 17 September 2018 the Netherlands (hereinafter ‘the Dossier Submitter’) submitted to the Agency an Annex XV dossier (8), proposing a restriction on eight PAHs in granules for use as infill material in synthetic turf pitches and of granules or mulches in loose form on playgrounds or in sport applications.

(5)

The human health endpoint of utmost concern for these eight PAHs is carcinogenicity and the ability to induce genotoxic effects. For non-threshold carcinogens, a dose without a theoretical cancer risk cannot be derived. Therefore, the concentrations of the eight PAHs in granules used as infill material in synthetic turf pitches and in granules or mulches in loose form on playgrounds or in sport applications should be as low as possible.

(6)

The Dossier Submitter took into consideration various exposure scenarios related to the use of granules in synthetic turf pitches, by workers installing and maintaining the pitches and by individuals playing sports on them (professional and amateur outfield players and goalkeepers), and related to granules or mulches used in loose applications on playgrounds and in sport applications, where people and especially children may be exposed. Based on the sampling results by RIVM, excess cancer risks were estimated on the basis of the total concentration of the sum of the eight PAHs currently found in ELT infills. The concentration range found for those mixtures was from 6,7 mg/kg to 21 mg/kg.

(7)

The Dossier Submitter showed that there is an excess cancer risk for workers and general public exposed to rubber granules containing the calculated mixture concentration limit of 387 mg/kg of the sum of the eight PAHs, whereas at a much lower level of concentration the probability that an individual’s exposure to the listed PAHs could result in cancer was estimated considerably lower. The Dossier Submitter concluded that for a large part of producers, concentrations of 15 to 21 mg/kg of the sum of the eight PAHs in ELT infill material are technically and economically feasible, and proposed to apply a concentration limit of 17 mg/kg. The Dossier Submitter estimated that 95 % of the ELT-derived infill material would comply with this concentration limit.

(8)

In order to ensure safe use of any granules or mulches and avoid substitution towards alternatives that may cause the same or even greater concern for human health than recycled rubber, the Dossier Submitter suggested that the restriction should cover mixtures made of recycled rubber and of other materials, may they be virgin or recycled, synthetic or natural materials.

(9)

As the limit value of 17 mg/kg proposed by the Dossier Submitter is significantly lower than the 100-1 000 mg/kg limit values that are currently applicable to the granules, the restriction would mean that some ELT-derived granule producerswould have to increase the rate of compliance testing and switch to cleaner production input or cease the production of infill material. The restriction would render 5 % of the currently produced granulesincompliant if the application of the restriction were to become effective immediately. Therefore, the Dossier Submitter suggested a transitional period of 12 months to allow a limited but reasonable period for downstream users (turf producers, distributors and companies installing the turf) to continue using granules that have already been supplied to them but do not comply with the proposed limit value of 17 mg/kg.

(10)

On 7 June 2019, the Agency’s Committee for Risk Assessment (RAC) adopted an opinion (9) concluding that a PAHs content in rubber granules corresponding to the calculated concentration limit for mixtures in accordance with entry 28 of Annex XVII to Regulation (EC) No 1907/2006 is unacceptable and such levels for non-threshold substances should not be permitted and they do not provide an adequate level of protection to workers and the general public. RAC agreed that the PAH content should be lowered and, recommended a concentration limit of 20 mg/kg of the sum of the eight PAHs in rubber granules. RAC reiterated that the proposed 20 mg/kg limit is not based upon the estimated risk but it is a measure aimed solely at avoiding very high PAH concentrations. RAC furthermore indicated that with respect to risk reduction there is no significant difference between choosing 17 mg/kg over 20 mg/kg, recognising that, except for smokers, the greatest exposure to the general public is not from granules and mulches but from food sources and inhaled air.

(11)

RAC agreed with the Dossier Submitter that, while no supporting information on the content of the eight PAHs in cork, thermoplastic elastomers (TPE) and ethylene propylene diene rubber (EPDM) has been provided, the proposed PAH limit should apply to any other type of synthetic pitch infill material in order to avoid similar or greater risk through regrettable substitution.

(12)

For enforcement reasons, RAC recommended that the restriction with respect to granules or mulches placed on the market for use as infill material in synthetic turf pitches and in loose form on playgrounds or in sport applications require a specific marking referring to a unique batch number. This batch number allows the traceability of the material to a tested batch placed on the market. Furthermore, RAC recommended including definitions for granules, mulches, infill material in synthetic turf pitches and use in loose form on playgrounds and in sport applications.

(13)

On 20 September 2019, the Agency’s Committee for Socioeconomic analysis (SEAC) adopted its opinion (10), indicating that the proposed restriction, as modified by RAC, is the most appropriate Union-wide measure to address the identified risks, taking into account its socioeconomic benefits and its socioeconomic costs. SEAC noted as well the preventive nature of the restriction.

(14)

SEAC agreed that the twelve-month deferral of application of the restriction initially proposed in the Annex XV dossier for a concentration level of 17 mg/kg, would also be appropriate for a concentration level of 20 mg/kg, in order to allow all concerned stakeholders to take the necessary compliance measures.

(15)

The Forum for Exchange of Information on Enforcement was consulted during the opinion making process and its recommendations were taken into account.

(16)

On 12 November 2019, the Agency submitted the opinions of RAC and SEAC to the Commission. Taking into account the Annex XV dossier and the RAC and SEAC opinions, the Commission considers that there is an unacceptable risk to human health from the placing on the market or use of granules or mulches containing PAH as infill material in synthetic turf pitches or in loose form on playgrounds or in sport applications that needs to be addressed on a Union wide basis. The Commission concludes that the restriction proposed in the Annex XV dossier, with the modifications proposed by RAC and SEAC, is the most appropriate Union-wide measure to address the risk identified to human health and that its socioeconomic impact is limited.

(17)

Regulation (EC) No 1907/2006 does not apply to waste as defined in Directive 2008/98/EC of the European Parliament and of the Council (11). In accordance with that Directive, in the absence of harmonised end-of-waste criteria at Union level, the competence to determine whether granules and mulches derived from ELT or other end-of-life products have achieved end-of-waste status in each case is with the Member States.

(18)

Stakeholders should be allowed sufficient time to take appropriate measures to comply with the proposed restriction. The application of the restriction should therefore be deferred by 12 months.

(19)

Regulation (EC) No 1907/2006 should therefore be amended accordingly.

(20)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

(1)

Pursuant to Decision 2001/79/CFSP, the Chairman of the Military Committee of the European Union (‘the Military Committee’) is to be appointed by the Council on the recommendation of the Military Committee meeting at the level of the Chiefs of Defence. In accordance with that Decision, the term of office of the Chairman of the Military Committee is three years, unless the Council decides otherwise.

(2)

On 20 February 2018, by means of Decision (CFSP) 2018/297 (2), the Council appointed General Claudio GRAZIANO as Chairman of the Military Committee, exceptionally, for a period of three-and-a-half years, from 6 November 2018.

(3)

At its meeting on 19 May 2021, the Military Committee meeting at the level of the Chiefs of Defence recommended that General Robert BRIEGER be appointed Chairman of the Military Committee for a period of three years starting on 1 June 2022.

(4)

The term of office of General Claudio GRAZIANO as Chairman of the Military Committee should therefore be extended until the beginning of the term of office of General Robert BRIEGER.

(5)

General Robert BRIEGER should be appointed Chairman of the Military Committee from 1 June 2022 to 31 May 2025,

(1)

In accordance with Article 14 of Regulation (EU) 2016/425 of the European Parliament and of the Council (2), personal protective equipment that is in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union, is to be presumed to be in conformity with the essential health and safety requirements set out in Annex II to that Regulation covered by those standards or parts thereof.

(2)

By letter M/031, entitled ‘Standardisation mandate to CEN/CENELEC concerning standards for personal protective equipment’, the Commission made a request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) to develop and draw up harmonised standards in support of Council Directive 89/686/EEC (3).

(3)

On the basis of the standardisation request M/031, CEN drafted several new standards and revised a number of existing harmonised standards.

(4)

On 19 November 2020 the standardisation request M/031 expired and was replaced by a new standardisation request as set out in Commission Implementing Decision C(2020)7924 (4).

(5)

As Regulation (EU) 2016/425 took over the essential health and safety requirements applicable to personal protective equipment laid down by Directive 89/686/EEC, draft harmonised standards developed under standardisation request M/031 are covered by the standardisation request set out in Implementing Decision C(2020)7924. Their references should therefore be published in the Official Journal of the European Union. It can therefore exceptionally be accepted that such standards developed and published by CEN and CENELEC during the period of transition between the standardisation request M/031 and the standardisation request set out in Implementing Decision C(2020)7924 do not contain an explicit reference to the standardisation request set out in Implementing Decision C(2020)7924.

(6)

On the basis of the standardisation request M/031 and the standardisation request set out in Implementing Decision C(2020)7924, CEN and CENELEC drafted the following new harmonised standards: EN 352-9:2020 on safety requirements for earplugs with safety-related audio input and EN 352-10:2020 on safety requirements for entertainment audio earplugs in support of Regulation (EU) 2016/425.

(7)

On the basis of the standardisation request M/031 and the standardisation request set out in Implementing Decision C(2020)7924, CEN revised the harmonised standards EN 352-1:2002, EN 352-2:2002, EN 352-3:2002, EN 352-4:2001, as amended by EN 352-4:2001/A1:2005, EN 352-5:2002, as amended by EN 352-5:2002/A1:2005, EN 352-6:2002, EN 352-7:2002 and EN 352-8:2008, the references of which are published in the C series of the Official Journal of the European Union (5). That revision resulted in the adoption of harmonised standards EN 352-1:2020 on general requirements for earmuffs, EN 352-2:2020 on general requirements for earplugs, EN 352-3:2020 on general requirements for earmuffs attached to head protection and/or face protection devices, EN 352-4:2020 on safety requirements for level-dependent earmuffs, EN 352-5:2020 on safety requirements for active noise reduction earmuffs, EN 352-6:2020 on safety requirements for earmuffs with safety-related audio input, EN 352-7:2020 on safety requirements for level-dependent earplugs and EN 352-8:2020 on safety requirements for entertainment audio earmuffs.

(8)

The Commission together with CEN and CENELEC has assessed whether the harmonised standards drafted and revised by CEN and CENELEC comply with the standardisation request set out in Implementing Decision C(2020)7924.

(9)

The harmonised standards EN 352-4:2020, EN 352-5:2020, EN 352-6:2020, EN 352-7:2020, EN 352-8:2020, EN 352-9:2020 and EN 352-10:2020 satisfy the requirements which they aim to cover and which are set out in Regulation (EU) 2016/425. It is therefore appropriate to publish the references of those harmonised standards in the Official Journal of the European Union.

(10)

The harmonised standards EN 352-1:2020, EN 352-2:2020 and EN 352-3:2020 do not contain the requirement for the products to bear labelling indicating the noise attenuation level provided by them. These harmonised standard should therefore be published in the Official Journal of the European Union with a restriction.

(11)

It is necessary to withdraw the references of harmonised standards EN 352-1:2002, EN 352-2:2002, EN 352-3:2002, EN 352-4:2001, as amended by EN 352-4:2001/A1:2005, EN 352-5:2002, as amended by EN 352-5:2002/A1:2005, EN 352-6:2002, EN 352-7:2002 and EN 352-8:2008 from the C series of the Official Journal of the European Union, given that those standards have been revised.

(12)

Annex I to Commission Implementing Decision (EU) 2020/668 (6) lists the references of harmonised standards drafted in support of Regulation (EU) 2016/425, while Annex II to Implementing Decision (EU) 2020/668 lists the references of harmonised standards drafted in support of Regulation (EU) 2016/425 that are withdrawn from the Official Journal of the European Union as from the dates set out in that Annex.

(13)

The harmonised standards EN 352-1:2020, EN 352-2:2020 and EN 352-3:2020 are the first harmonised standards drafted in support of Regulation (EU) 2016/425 to be published in the Official Journal of the European Union with a restriction. A new Annex should be added to Implementing Decision (EU) 2020/668, listing the references of harmonised standards drafted in support of Regulation (EU) 2016/425 published in the Official Journal of the European Union with a restriction.

(14)

Implementing Decision (EU) 2020/668 should therefore be amended accordingly.

(15)

In order to give manufacturers sufficient time to prepare for the application of the revised standards, it is necessary to defer the respective withdrawal of the references to the standards listed in Annex II.

(16)

Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should enter into force on the day of its publication,

(1)

the following Article 2a is inserted:

(2)

Annex I is amended in accordance with Annex I to this Decision;

(3)

Annex II is amended in accordance with Annex II to this Decision;

(4)

the text set out in Annex III to this Decision is added as Annex III.