title: COMMISSION DIRECTIVE (EU) .../… amending Annex II to Directive 2009/48/EC of the European Parliament and of the Council as regards the labelling of allergenic fragrances in toys

text:
               COMMISSION DIRECTIVE (EU) .../…

               of 11.12.2020

               amending Annex II to Directive 2009/48/EC of the European Parliament and of the Council as regards the labelling of allergenic fragrances in toys

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys
                  1
               , and in particular point (b) of the first subparagraph of Article 46(1) thereof,

               Whereas:

               (1)Directive 2009/48/EC lays down a general obligation to list on the toy, on an affixed label, on the packaging or in an accompanying leaflet, if added to a toy, the names of 11 allergenic fragrances if the concentrations of those fragrances exceed 100 mg/kg in the toy or components thereof. Those allergenic fragrances are listed in the table in the third paragraph of point 11 of Part III of Annex II to that Directive.

               (2)The Scientific Committee on Consumer Safety (SCCS), which assists the Commission as an independent risk assessment body in the area of cosmetic products, notes in its opinion of 26 and 27 June 2012
                  2
                that contact allergy to fragrances is a common, significant and relevant problem in Europe and that exposure to fragrances occurs from the use of other consumer products, such as toys. The SCCS also notes that, in recent years, it has become a trend to add fragrance chemicals to many types of consumer products, such as children’s toys, which may contribute significantly to the fragrance exposure of the consumer by the dermal route. The SCCS adds that the consumer is exposed to fragrance substances from a wide variety of cosmetic products, other consumer products, pharmaceuticals and occupational exposures, and that all those exposures are of importance in the context of contact allergy as it is not the source of exposure that is critical, but the cumulative dose per unit area. In the opinion, a number of established contact allergens in humans are listed in Table 13-1.

               (3)A survey of allergenic substances in products for children carried out by the Environmental Protection Agency in Denmark
                  3
                shows the presence of allergenic fragrances in toys, namely modelling clays, slimes, a doll, a teddy bear, and rubber bands.

               (4)The Expert Group on Toys Safety advises the Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety. The mission of its subgroup on Chemicals in Toys (subgroup Chemicals) is to provide advice with regard to chemical substances which may be used in toys.

               (5)The Expert Group on Toys Safety recalled, at its meeting on 13 September 2019
                  4
               , that an allergenic substance, whether present in cosmetic products or in toys, is always allergenic. That so-called intrinsic property of the substance is independent from the use of the substance and is therefore present irrespective of whether the allergenic substance is used in cosmetics or in toys. Consequently, the Expert Group considered that an allergenic substance presenting a risk in cosmetic products could equally present a risk in toys. It therefore underlined the importance to take thorough account of the opinions of the SCCS and of its predecessor committees on allergenic fragrances in cosmetic products when regulating allergenic fragrances in toys.

               (6)At the meeting of the subgroup Chemicals of 3 May 2018
                  5
               , the majority of its members concluded that the established contact allergens in humans listed in Table 13-1 of the SCCS opinion of 26 and 27 June 2012 should be added to the list of allergenic fragrances that have to be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, laid down in the table in the third paragraph of point 11 of Part III of Annex II to Directive 2009/48/EC.

               (7)On 13 September 2019, the Expert Group on Toys Safety confirmed the conclusions of the subgroup Chemicals.

               (8)At its meeting on 13 September 2019, the Expert Group on Toys Safety noted that entry 4 in the table in the third paragraph of point 11 of Part III of Annex II to Directive 2009/48/EC on citronellol, CAS number 106-22-9, covers only the mixture of the two enantiomeric forms of citronellol. The labelling requirements should however, according to the Expert Group, also cover the two individual enantiomeric forms listed as CAS numbers 1117-61-9 and 7540-51-4 in Table 13-1 of the SCCS opinion of 26 and 27 June 2012.

               (9)In light of the SCCS opinion of 26 and 27 June 2012 and the recommendation of the Expert Group on Toys Safety of 13 September 2019, the allergenic fragrances listed in Table 13-1 of the SCCS opinion of 26 and 27 June 2012 should be subject to labelling requirements when present in toys. The fragrances that are not yet subject to a prohibition or labelling requirements laid down in Directive 2009/48/EC, should therefore be included in the table in the third paragraph of point 11 of Part III of Annex II to that Directive.

               (10)Directive 2009/48/EC should therefore be amended accordingly.

               (11)The measures provided for in this Directive are in accordance with the opinion of the Committee established under Article 47(1) of Directive 2009/48/EC,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               Annex II to Directive 2009/48/EC is amended in accordance with the Annex to this Directive.

               Article 2

               1.
                     Member States shall adopt and publish, by … [18 months after publication in the OJ] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

               They shall apply those provisions from … [18 months  + 1 day after publication in the OJ].

               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               2.
                     Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

               Article 3

               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 11.12.2020

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 170, 30.6.2009, p. 1.

                     (2)

                        SCCS opinion on fragrance allergens in cosmetic products, 26 – 27 June 2012 (SCCS/1459/11).
                  http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_102.pdf

                     (3)

                        Ministry of Environment and Food of Denmark - Environmental Protection Agency. Survey of allergenic substances in products targeted children – toys and cosmetic products. Survey of Chemical Substances in Consumer Products No. 148, 2016.

                  https://www2.mst.dk/Udgiv/publications/2016/08/978-87-93529-00-7.pdf

                     (4)

                        Minutes of the meeting of the Expert Group on Toys Safety of 13 September 2019

                  https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=17996

                     (5)

                        Minutes of the Meeting of the subgroup Chemicals of the Expert Group on Toy Safety of 3 May 2018.
                  https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeetingDoc&docid=19025
                  .

    ---documentbreak---

               ANNEX

               In the third paragraph of point 11 of Part III of Annex II, the table is amended as follows:

               (1)entry 4 is replaced by the following:

                        No

                        Name of the allergenic fragrance

                        CAS number

                        ‘(4)

                        Citronellol

                        106-22-9; 1117-61-9;
                           7540-51-4’;

               (2)the following entries are added:

                        No

                        Name of the allergenic fragrance

                        CAS number

                        ‘(12)

                        Acetylcedrene

                        32388-55-9

                        (13)

                        Amyl salicylate

                        2050-08-0

                        (14)

                        trans-Anethole

                        4180-23-8

                        (15)

                        Benzaldehyde

                        100-52-7

                        (16)

                        Camphor

                        76-22-2; 464-49-3

                        (17)

                        Carvone

                        99-49-0; 6485-40-1;
                           2244-16-8

                        (18)

                        beta-Caryophyllene (ox.)

                        87-44-5

                        (19)

                        Rose ketone-4 (Damascenone )

                        23696-85-7

                        (20)

                        alpha-Damascone (TMCHB)

                        43052-87-5; 23726-94-5

                        (21)

                        cis-beta-Damascone

                        23726-92-3

                        (22)

                        delta-Damascone

                        57378-68-4

                        (23)

                        Dimethylbenzyl carbinyl acetate (DMBCA)

                        151-05-3

                        (24)

                        Hexadecanolactone

                        109-29-5

                        (25)

                        Hexamethylindanopyran

                        1222-05-5

                        (26)

                        (DL)-Limonene

                        138-86-3

                        (27)

                        Linalyl acetate

                        115-95-7

                        (28)

                        Menthol

                        1490-04-6; 89-78-1;
                           2216-51-5

                        (29)

                        Methyl salicylate

                        119-36-8

                        (30)

                        3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol

                        67801-20-1

                        (31)

                        alpha-Pinene

                        80-56-8

                        (32)

                        beta-Pinene

                        127-91-3

                        (33)

                        Propylidene phthalide

                        17369-59-4

                        (34)

                        Salicylaldehyde

                        90-02-8

                        (35)

                        alpha-Santalol

                        115-71-9

                        (36)

                        beta-Santalol

                        77-42-9

                        (37)

                        Sclareol

                        515-03-7

                        (38)

                        alpha-Terpineol

                        10482-56-1; 98-55-5

                        (39)

                        Terpineol (mixture of isomers)

                        8000-41-7

                        (40)

                        Terpinolene

                        586-62-9

                        (41)

                        Tetramethyl acetyloctahydro naphthalenes

                        54464-57-2; 54464-59-4; 68155-66-8; 68155-67-9

                        (42)

                        Trimethyl benzenepropanol (Majantol)

                        103694-68-4

                        (43)

                        Vanillin

                        121-33-5

                        (44)

                        Cananga odorata and Ylang-ylang oil

                        83863-30-3; 8006-81-3

                        (45)

                        Cedrus atlantica bark oil

                        92201-55-3; 8000-27-9

                        (46)

                        Cinnamomum cassia leaf oil

                        8007-80-5

                        (47)

                        Cinnamomum zeylanicum bark oil

                        84649-98-9

                        (48)

                        Citrus aurantium amara flower oil

                        8016-38-4

                        (49)

                        Citrus aurantium amara peel oil

                        72968-50-4

                        (50)

                        Citrus bergamia peel oil expressed

                        89957-91-5

                        (51)

                        Citrus limonum peel oil expressed

                        84929-31-7

                        (52)

                        Citrus sinensis (syn.: Aurantium dulcis) peel oil expressed

                        97766-30-8; 8028-48-6

                        (53)

                        Cymbopogon citratus / schoenanthus oils

                        89998-14-1; 8007-02-01; 89998-16-3

                        (54)

                        Eucalyptus spp. leaf oil

                        92502-70-0; 8000-48-4

                        (55)

                        Eugenia caryophyllus leaf / flower oil

                        8000-34-8

                        (56)

                        Jasminum grandiflorum / officinale

                        84776-64-7; 90045-94-6; 8022-96-6

                        (57)

                        Juniperus virginiana

                        8000-27-9; 85085-41-2

                        (58)

                        Laurus nobilis fruit oil

                        8007-48-5

                        (59)

                        Laurus nobilis  leaf oil

                        8002-41-3

                        (60)

                        Laurus nobilis seed oil

                        84603-73-6

                        (61)

                        Lavandula hybrida

                        91722-69-9

                        (62)

                        Lavandula officinalis

                        84776-65-8

                        (63)

                        Mentha piperita

                        8006-90-4; 84082-70-2

                        (64)

                        Mentha spicata

                        84696-51-5

                        (65)

                        Narcissus spp.

                        Diverse, including 90064-25-8

                        (66)

                        Pelargonium graveolens

                        90082-51-2; 8000-46-2

                        (67)

                        Pinus mugo

                        90082-72-7

                        (68)

                        Pinus pumila

                        97676-05-6

                        (69)

                        Pogostemon cablin

                        8014-09-3; 84238-39-1

                        (70)

                        Rose flower oil (Rosa spp.)

                        Diverse, including 8007-01-0, 93334-48-6, 84696-47-9, 84604-12-6, 90106-38-0, 84604-13-7, 92347-25-6

                        (71)

                        Santalum album

                        84787-70-2; 8006-87-9

                        (72)

                        Turpentine (oil)

                        8006-64-2; 9005-90-7;
                           8052-14-0'.


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards the validity period of an exemption for the use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               This Commission Delegated Directive amends, for the purpose of adapting to technical progress, Annex IV of Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)
                  1
                (RoHS) as regards an exemption for specific applications containing mercury.

               RoHS restricts the use of certain hazardous substances in electrical and electronic equipment, as provided for in its Article 4. It entered into force on 21 July 2011.

               The currently restricted substances as listed in Annex II to RoHS are the following: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2‑ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP). Annexes III and IV to RoHS list the materials and components of electrical and electronic equipment (EEE) for specific applications exempted from the substance restriction of RoHS Article 4(1).

               Article 5 provides for the adaptation to scientific and technical progress (inclusion, renewal, amendments and revoking of exemptions) of Annexes III and IV. Pursuant to Article 5(1)(a), exemptions are to be included in Annexes III and IV only if such inclusion does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 (REACH)
                  2
                and where any of the following conditions is fulfilled: their elimination or substitution via design changes or materials and components which do not require any of the materials or substances listed in Annex II is scientifically or technically impracticable; the reliability of substitutes is not ensured; or the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof.

               Decisions on exemptions, and their duration, are furthermore to take into account the availability of substitutes and the socioeconomic impact of substitution; and decisions on the duration of exemptions shall take into account any potential impact on innovation. Life-cycle thinking on the overall impacts of the exemption shall apply, where relevant.

               Furthermore, Article 5(1) provides that the European Commission (the Commission) shall include materials and components of EEE for specific applications in the lists in Annexes III and IV by means of individual delegated acts in accordance with Article 20. Article 5(3) and Annex V establish the procedure for submitting applications for granting, renewing, or revoking an exemption.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               Since the publication of the RoHS Directive, the Commission has received numerous
                  3
                requests from economic operators, according to the provisions in Article 5(3) and Annex V, for both granting new and renewing existing exemptions.

               The current Annex IV exemption 42 permits the use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems capable of high operating frequency (> 50 MHz) modes of operation.

               The Commission received one application for renewal of this exemption in October 2017. While exemption 42 had 30 June 2019 as expiration date, in line with the requirements of the RoHS Directive (Article 5(5), second subparagraph), it continues to apply until a decision on the renewal application is taken by the Commission.

               With a view to evaluating the application for exemption, the Commission launched a study to carry out the required technical and scientific assessment, including a seven‑week online open‑ended stakeholder consultation
                  4
                on the application. No contributions were made to the stakeholder consultation.

               The final report containing the assessment of the application was published
                  5
               ; stakeholders were notified.

               Subsequently, the Commission consulted the Member States expert group for delegated acts under RoHS during an expert meeting on 21 October 2019. The experts agreed with the draft presented, with a large group of experts remaining silent. All necessary steps relating to exemptions from the substance restriction pursuant to Articles 5(3) to 5(7) have been performed.
                  6
                In accordance with the Better Regulation Guidelines, the draft Delegated Directive was published on the Better Regulation Portal for a four-week public feedback period. No comments were received. The Council and the European Parliament were notified of all activities.

               The final report highlighted in particular the following technical information and assessment:

               ·Intravascular ultrasound (IVUS) imaging is a technique that emits sound energy from a transducer at the tip of a small catheter that is guided into the coronary arteries of the heart. Sound waves reflected from vascular tissues are received by the transducer and sent to the system console, where a high resolution, cross sectional image is displayed in real time. The IVUS technique provides in vivo visualization of the coronary artery lumen, coronary artery wall morphology, and devices (such as stents) at or near the surface of the coronary artery wall. Mercury is used in slip rings which provide the electrical conduction path between the rotating transducer and stationary electronic equipment. The use of mercury enables inter alia higher frequency operation which allows obtaining higher resolution imaging beneficial for patients.

               ·Currently, the substitution of mercury in applications concerned is technically impracticable.

               The evaluation results show that the specific exemption would not weaken the environmental and health protection afforded by the REACH Regulation, in accordance with Article 5 of Directive 2011/65/EU. Furthermore, at least one of the relevant criteria specified in Article 5(1)(a) is met by the exemption request: Since for the applications concerned, no reliable alternatives are available today or are likely to come on the market soon, granting the exemption with the validity period until 30 June 2026 is justified. As reliable substitutes are not yet available, no negative socioeconomic impacts of substitution are to be anticipated for this period. The granted validity period is also not expected to have adverse impacts on innovation.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               The Delegated Directive grants an extension of the validity period of an exemption listed in Annex IV of Directive 2011/65/EU, for the use of mercury in specific applications.

               The instrument is a Delegated Directive, as provided for by Directive 2011/65/EU, and in particular meeting the relevant requirements of Article 5(1)(a) thereof.

               The objective of the Delegated Directive is to contribute to the protection of human health and the environment and approximate the provisions for the functioning of the internal market in the field of electrical and electronic equipment, by allowing the use of otherwise banned substances for specific applications, in line with the provisions and under the conditions of RoHS and the therein established procedure for the adaptation of the Annexes III and IV to scientific and technical progress.

               The delegated directive has no implications for the EU budget.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 8.3.2021

               amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards the validity period of an exemption for the use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment
                  7
               , and in particular Article 5(1)(a) thereof,

               Whereas:

               (1)Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications which are specific to medical devices and monitoring and control instruments and are listed in Annex IV to that Directive.

               (2)The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive.

               (3)Mercury is a restricted substance listed in Annex II to Directive 2011/65/EU.

               (4)By Delegated Directive (EU) 2015/574
                  8
               , the Commission granted an exemption for the use of mercury in intravascular ultrasound imaging systems (“the exemption”), by including that application in Annex IV to Directive 2011/65/EU. The exemption was to expire on 30 June 2019, in accordance with the third subparagraph of Article 5(2) of that Directive.

               (5)The Commission received an application for renewal of the exemption (“the renewal request”) on 6 October 2017 that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU. In accordance with that provision, the exemption remains valid until a decision on the renewal request has been adopted.

               (6)The evaluation of the renewal request included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The comments received during these consultations were made publicly available on a dedicated website.

               (7)Mercury is used in electric rotating connectors of intravascular ultrasound imaging systems which provide the electrical conduction path between the rotating transducer and stationary electronic equipment. The use of mercury enables inter alia higher frequency operation which allows obtaining higher resolution imaging beneficial for patients.

               (8)Due to the lack of alternatives, a substitution or elimination of mercury in the applications concerned is currently scientifically and technically impracticable. The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  9
                and thus does not weaken the environmental and health protection afforded by it.

               (9)It is, therefore, appropriate to grant the renewal of the exemption.

               (10)The exemption should be renewed for the maximum duration of 7 years until 30 June 2026, in accordance with Article 4(3) and the third subparagraph of Article 5(2) of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation.

               (11)Directive 2011/65/EU should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

               Article 2

               1.Member States shall adopt and publish, by [the last day of the 12th month after the date of entry into force of this Directive] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

               They shall apply those provisions from [the last day of the 12th month after the date of entry into force of this Directive + 1 day].

               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

               Article 3

               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 8.3.2021

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 174, 1.7.2011, p. 88.

                     (2)

                        OJ L 396, 30.12.2006, p. 1.

                     (3)

                        The list is given at:
                  http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm

                     (4)

                  Consultation period
                  : from 31 October 2018 until 19 December 2018.

                     (5)

                     https://op.europa.eu/en/publication-detail/-/publication/7e6bf135-f0b9-11e9-a32c-01aa75ed71a1/language-en/format-PDF/source-120742148

                     (6)

                        A list of the required administrative steps is available on the
                  Commission website
                  . Current stage of the procedure can be viewed for each draft delegated act in the Interinstitutional Registry of Delegated Acts at
                  https://webgate.ec.europa.eu/regdel/#/home
                  .

                     (7)

                        OJ L 174, 1.7.2011, p. 88.

                     (8)

                        Commission Delegated Directive (EU) 2015/574 of 30 January 2015 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for mercury in intravascular ultrasound imaging systems (OJ L 94, 10.4.2015, p. 6).

                     (9)

                        Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

    ---documentbreak---

               ANNEX

               In entry 42 of Annex IV to Directive 2011/65/EU, the second paragraph is replaced by the following:

               "Expires on 30 June 2026."


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending Directive 2014/45/EU of the European Parliament and of the Council as regards the updating of certain vehicle category designations and the addition of eCall to the list of test items, methods, reasons for failure and assessment of deficiencies in Annex I and Annex III to that Directive

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               Directive 2014/45/EU
                  1
                of the European Parliament and of the Council on periodic roadworthiness tests for motor vehicles and their trailers repealing Directive 2009/40/EC
                  2
                establishes minimum requirements for a regime of periodic roadworthiness tests of vehicles and their trailers used on public roads. Roadworthiness testing is a part of a wider regime designed to ensure that vehicles are kept in a safe and environmentally acceptable condition during their use, and that regime covers periodic roadworthiness testing of vehicles in accordance with Directive 2014/45/EU and technical roadside inspection of vehicles used for commercial road transport activities in accordance with Directive 2014/47/EU
                  3
               .

               Directive 2014/45/EU shall apply to vehicles with a design speed exceeding 25km/h of the categories set out in Article 2(1), as referred to in Directive 2002/24/EC
                  4
               , Directive 2003/37/EC
                  5
                and Directive 2007/46/EC
                  6
                of the European Parliament and of the Council. Given the changes to the vehicle category designations stemming from the repeal of Directive 2003/37/EC by Regulation (EU) No 167/2013
                  7
                and of Directive 2002/24/EC by Regulation (EU) 168/2013
                  8
                respectively, this delegated act aims to update the references to the relevant vehicle categories, in order to align them with the changes to the type-approval legislation.

               Furthermore, following a positive assessment of the costs and benefits involved, and following the adoption of Regulation (EU) No 2015/758
                  9
               , which established the general requirements for the EC type-approval of vehicles in respect of the 112-based eCall in-vehicle systems, and of 112-based eCall in-vehicle systems, components and separate technical units, point 3 of Annex I of Directive 2014/45/EU also needs to be adapted accordingly. The 112-based eCall in-vehicle system needs to remain functional through the whole life cycle of the vehicle, as its mandatory introduction is expected to contribute to the reduction of fatalities and severe injuries, and of costs relating to healthcare.

               In accordance with point 14 of section I of Annex III of Directive 2014/45/EU, the minimum requirements concerning roadworthiness facilities and test equipment, applicable as from 20 May 2023, include a device to connect to the electronic vehicle interface, such as an on-board diagnostics systems (OBD) scan tool. On the basis of the cost-benefit analysis
                  10
                for the different eCall test scenarios, the testing via electronic vehicle interface including function and performance of the system gives the best cost-benefit ratio. However, taking into account the possibility that not all vehicles might be equipped with an OBD connector, the testing via electronic vehicle interface seems not to be feasible in these cases.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               In January 2019 a study on the inclusion of eCall in the periodic roadworthiness testing of motor vehicles was finalized. The aim of the study was to assess whether it is cost-effective to include eCall within the frame of Directive 2014/45/EU and, in case of a positive answer, to assess the possible testing scenarios. For the purposes of the study, the opinion of stakeholders has been considered by means of a survey sent to 537 recipients and a workshop was organized in Brussels on 8 June 2018. Furthermore, the views of the members of the Roadworthiness Committee were taken into consideration during the meeting of 20 September 2018. The final report of the study was presented at the Roadworthiness Committee meeting of 24 June 2019.

               In May 2020, the Commission set up an Expert Group on Roadworthiness and Vehicle Registration Documents (RWEG). The mission of the RWEG is to assist DG MOVE in the preparation of non-legislative acts in the fields of roadworthiness and vehicle registration documents, including the preparation of delegated and implementing acts, to assist the Commission in the preparation of relevant guidance in relation to the relevant Directives, and to bring about an exchange of experience and good practice in those fields. The RWEG has examined the draft text of the delegated act during its meetings on 17 September 2020 and 25 November 2020. The draft of this Directive has been subject to a public consultation through the Better Regulation Portal from 16 April 2021 to 14 May 2021, receiving in total 4 responses. One response concerned the maximum vehicle mass for the category B driving license, an issue not directly linked with this act, one response concerned a clarification for the scope of eCall testing and two responses gave general support to the initiative.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               The Delegated Act is based on the first and third indents of Article 17 of Directive 2014/45/EU.

               According to the first indent of Article 17 of Directive 2014/45/EU, the Commission shall be empowered to adopt delegated acts in accordance with Article 18 in order to update the vehicle category designations referred to in Article 2(1) and Article 5(1) and (2) as appropriate in the event of changes to the vehicle categories stemming from amendments to the type-approval legislation referred to in Article 2(1), without affecting the scope and frequency of testing.

               The vehicle category designations referred to in Article 2(1) and in Article 5(1) and (2) of Directive 2014/45/EU are also referred in other provisions of that same Directive. In order to ensure the coherency and legal certainty of Directive 2014/45/EU, those designations, even though they are not expressly mentioned in the first indent of Article 17, need to be updated in accordance with the changes that resulted from the repeal of Directive 2002/24/EC by Regulation (EU) No 168/2013, and from the repeal of Directive 2003/37/EC by Regulation (EU) No 167/2013. Otherwise, this could lead to inconsistencies and legal uncertainty. This is notably the case for Article 6 of and Annex III to the Directive. Such an updated will not affect the scope and frequency of the testing.

               According to the third indent of Article 17 of Directive 2014/45/EU, the Commission shall also be empowered to adopt delegated acts in accordance with Article 18 in order to adapt point 3 of Annex I, following a positive assessment of the costs and benefits involved, in respect of the list of test items, methods, reasons for failure and assessment of deficiencies in the event of a modification of mandatory requirements relevant for type-approval in Union safety or environmental legislation.

               Regulation (EU) No 2015/758 concerning type-approval requirements for the deployment of the eCall in-vehicle system based on the 112 service lays down, in its Article 4, that manufacturers shall demonstrate that all new types of vehicles referred to in Article 2 are equipped with a permanently installed 112-based eCall in-vehicle system, in accordance with that Regulation and with the delegated and implementing acts adopted pursuant to that Regulation. According to these new mandatory requirements, Directive 2014/45/EU should therefore be adapted accordingly.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 9.7.2021

               amending Directive 2014/45/EU of the European Parliament and of the Council as regards the updating of certain vehicle category designations and the addition of  eCall to the list of test items, methods, reasons for failure and assessment of deficiencies in Annex I and Annex III to that Directive

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2014/45/EU of the European Parliament and of the Council of 3 April 2014 on periodic roadworthiness tests for motor vehicles and their trailers and repealing Directive 2009/40/EC
                  11
               and in particular Article 17 thereof,

               Whereas:

               (1)Directive 2014/45/EU applies to vehicles with a design speed exceeding 25km/h of the categories listed in Article 2(1) of that Directive. Those categories are determined by reference to Directives 2002/24/EC
                  12
               , 2003/37/EC
                  13
                and 2007/46/EC
                  14
                of the European Parliament and of the Council.

               (2)Directives 2002/24/EC, 2003/37/EC and 2007/46/EC were repealed, respectively, by Regulations (EU) No 168/2013, (EU) No 167/2013 and (EU) 2018/858 of the European Parliament and of the Council.

               (3)Given the changes to the vehicle category designations that stemmed from the repeal of Directives 2002/24/EC and 2003/37/EC, certain vehicle category designations referred to in Directive 2014/45/EC should be adapted. Those changes do not affect the scope and frequency of the testing.

               (4)Regulation (EU) 2015/758
                  15
                of the European Parliament and of the Council lays down an obligation for certain new types of vehicles to be equipped with a permanently installed 112-based eCall in-vehicle system, with effect from 31 March 2018.

               (5)The 112-based eCall in-vehicle system, as an emergency system, requires the highest possible level of reliability. The accuracy of the minimum set of data and of the voice transmission, and quality, should be ensured, and a uniform testing regime should be developed to ensure the longevity and durability of the 112-based eCall in-vehicle system. Periodic roadworthiness tests for eCall should therefore be carried out regularly in accordance with Directive 2014/45/EU. A new point relating to such a test should be added in Table 3 of Annex I to that Directive.

               (6)Directive 2014/45/EU should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               Directive 2014/45/EU is amended as follows:

               (1)Article 2 is amended as follows:

               (a)paragraph 1 is amended as follows:

               (i)the introductory wording is replaced by the following:

               “1. This Directive shall apply to vehicles with a design speed exceeding 25km/h of the following categories, as referred to in Regulations (EU) 167/2013*, (EU) 168/2013**, and (EU) 2018/858*** of the European Parliament and of the Council:

               * Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).

               ** Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52).

               *** Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1)”;

               (ii)
                     the sixth and seventh indents are replaced by the following:

               “— from 1 January 2022, two- or three-wheel vehicles – vehicle categories L3e, L4e, L5e and L7e equipped with a combustion engine with a displacement of more than 125 cm³;

               “— wheeled tractors of categories  T1b, T2b, T3b, T4.1b, T4.2b and T4.3b the use of which mainly takes place on public roads with a maximum design speed exceeding 40km/h.”;

               (b)in paragraph 2, the seventh indent is replaced by the following

               “— vehicles in categories L3e, L4e, L5e and L7e equipped with a combustion engine with a displacement of more than 125 cm³ where the Member State has put in place effective alternative road safety measures for two or three-wheel vehicles, taking into account in particular relevant road safety statistics covering the last five years. Member States shall notify such exemptions to the Commission.”;

               (2)Article 5 is amended as follows:

               (a)in paragraph 1, point (c) is replaced by the following:

               “(c) wheeled tractors of categories T1b, T2b, T3b, T4.1b, T4.2b and T4.3b the use of which mainly takes place on public roads for commercial road haulage purposes: four years after the date on which the vehicle was first registered, and thereafter every two years.”;

               (b)paragraph 2 is replaced by the following:

               “2. Member States shall establish appropriate intervals within which vehicles of categories L3e, L4e, L5e and L7e equipped with a combustion engine with a displacement of more than 125 cm³, are to be subject to a roadworthiness test.”;

               (3) Annexes I and III are amended in accordance with the Annex to this Directive.

               Article 2

               Transposition

               1. Member States shall adopt and publish, by [OP: please insert the date – one year after the publication date of this act] at the latest, the laws, regulations and administrative measures necessary to comply with this Directive.. They shall forthwith communicate to the Commission the text of those provisions.

               They shall apply the measures necessary to comply with Article 1 and point (2) of the Annex of this Directive from [OP: please insert the date - one year after the publication date of this act].

               They shall apply the measures necessary to comply with point 1 of the Annex to this Directive from 20 May 2023 at the latest.

               When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.

               2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. Article

               Article 3

               Entry into force

               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               Article 4

               Addressees

               This Directive is addressed to the Member States.

               Done at Brussels, 9.7.2021

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        Directive 2014/45/EU of the European Parliament and of the Council of 3 April 2014 on periodic roadworthiness tests for motor vehicles and their trailers and repealing Directive 2009/40/EC (OJ L 127, 29.4.2014, p. 51)

                     (2)

                        Directive 2009/40/EC of the European Parliament and of the Council of 6 May 2009 on roadworthiness tests for motor vehicles and their trailers (OJ L 141, 6.6.2009, p. 12)

                     (3)

                        Directive 2014/47/EU of the European Parliament and of the Council of 3 April 2014 on the technical roadside inspection  of the roadworthiness of commercial vehicles circulating in the Union and repealing Directive 2000/30/EC (OJ L 127, 29.4.2014, p. 134)

                     (4)

                        Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles and repealing Council Directive 92/61/EEC (OJ L 124, 9.5.2002, p. 1).

                     (5)

                        Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Directive 74/150/EEC (OJ L 171, 9.7.2003, p. 1).

                     (6)

                        Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (OJ L 263, 9.10.2007, p. 1).

                     (7)

                        Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).

                     (8)

                        Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52)

                     (9)

                        Regulation (EU) 2015/758 of the European Parliament and of the Council of 29 April 2015 concerning type-approval requirements for the deployment of the eCall in-vehicle system based on the 112 service and amending Directive 2007/46/EC (OJ L 123, 19.5.2015, p. 77).

                     (10)

                  https://op.europa.eu/en/publication-detail/-/publication/c6524bd7-2b54-11e9-8d04-01aa75ed71a1

                     (11)

                        Directive 2009/40/EC of the European Parliament and of the Council of 6 May 2009 on roadworthiness tests for motor vehicles and their trailers (OJ L 141, 6.6.2009, p. 12).

                     (12)

                        Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles and repealing Council Directive 92/61/EEC (OJ L 124, 9.5.2002, p. 1).

                     (13)

                        Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Directive 74/150/EEC (OJ L 171, 9.7.2003, p. 1).

                     (14)

                        Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (OJ L 263, 9.10.2007, p. 1).

                     (15)

                        Regulation (EU) 2015/758 of the European Parliament and of the Council of 29 April 2015 concerning type-approval requirements for the deployment of the eCall in-vehicle system based on the 112 service and amending Directive 2007/46/EC (OJ L 123, 19.5.2015, p. 77)

    ---documentbreak---

               ANNEX

               Annexes I and III are amended as follows:

               (1)in point 3 of Annex I, the following point is added to section 7:

                        Item

                        Method

                        Reasons for failure

                        Assessment of deficiencies

                        Minor

                        Major

                         Dangerous

                        7.13        eCall (if fitted, in accordance with EU type approval legislation)

                                 7.13.1     Fitment and configuration

                                 on

                        Visual inspection  complemented, where made possible by the technical characteristics of the vehicle and where the necessary data is made available, with the use of electronic interface

                                 (a)

                                  System or any component missing

                          X

                                 (b)

                                  Software version incorrect

                        X

                                 (c)   System coding incorrect

                                 (

                        X

                                 7.13.2     Condition

                        Visual inspection  complemented, where made possible by the technical characteristics of the vehicle and where the necessary data is made available, with the use of electronic interface

                        (a)   System or components damaged

                        X

                        (b)  eCall MIL indicates any kind of failure of the system

                        X

                        (c)   eCall electronic control unit failure

                        X

                        (d) Mobile network communication device   failure

                        X

                        (e)   GPS signal failure

                        X

                        (f)   Audio components not connected

                        X

                        (g) Power source not connected or insufficient charge

                        X

                        (h)   System indicates failure via the electronic vehicle interface

                        X

                         7.13.3  Performance

                        Visual inspection  complemented, where made possible by the technical characteristics of the vehicle and where the necessary data is made available, with the use of electronic interface

                        (a)   Minimum set of data (MSD) incorrect

                        X

                        (b)   Audio components not working in order

                        X

               (2)in Annex III, point 4 of Table I is amended as follows:

               (a)the title is replaced by the following:

               “Special vehicles derived from a category N vehicle, T1b, T2b, T3b, T4.1b, T4.2b and T4.3b”;

               (b)references to “T5” vehicles are replaced by a reference the following categories:

               “T1b, T2b, T3b, T4.1b, T4.2b and T4.3b (P) and T1b, T2b, T3b, T4.1b, T4.2b and T4.3b (D)


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               This Commission Delegated Directive amends, for the purpose of adapting to technical and scientific progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)
                  1
                (the RoHS Directive) as regards an exemption for specific applications containing bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).

               Article 4 of the RoHS Directive restricts the use of certain hazardous substances in electrical and electronic equipment (EEE). Currently, 10 substances are restricted and listed in Annex II to the Directive: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), DEHP, BBP, DBP and DIBP.

               Annexes III and IV to the RoHS Directive list the materials and components of EEE for specific applications exempted from the substance restrictions in Article 4(1). DEHP, BBP, DBP and DIBP were added to the list of restricted substances in Annex II by Commission Delegated Directive (EU) 2015/863
                  2
                and will be prohibited in medical devices covered by the Directive from 22 July 2021. The restriction will not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of medical devices, including in vitro medical devices, placed on the market before that date.

               Article 4(4) of the RoHS Directive excludes spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before certain dates. Article 4(5) allows the reuse of spare parts recovered from medical devices placed on the market before 22 July 2014 (22 July 2016 in the case of in vitro diagnostic medical devices) and used in EEE placed on the market before 22 July 2024 (22 July 2026), provided that the reuse takes place in auditable closed-loop business-to-business return systems and is notified to the customer.

               Article 5 of the Directive provides for Annexes III and IV to be adapted to scientific and technical progress (as regards the granting, renewing and revoking of exemptions). Under Article 5(1)(a), exemptions are to be included in Annexes III and IV only if this does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 (REACH)
                  3
                and any of the following conditions is fulfilled:

               –their elimination or substitution via design changes or materials and components that do not require any of the materials or substances listed in Annex II is scientifically or technically impracticable;

               –the reliability of substitutes is not ensured;

               –the total negative environmental, health and consumer safety impacts of substitution are likely to outweigh the total environmental, health and consumer safety benefits.

               Decisions on exemptions, and their duration, are to take into account the availability of substitutes and the socio‑economic impact of substitution. Decisions on the duration of exemptions must take into account any potential impact on innovation. Life-cycle thinking on the overall impacts of the exemption must apply, where relevant.

               Article 5(1) of the RoHS Directive provides for the Commission to include materials and components of EEE for specific applications in the lists in Annexes III and IV by means of individual delegated acts pursuant to Article 20. Article 5(3) and Annex V establish the procedure for submitting exemption applications.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               The Commission receives numerous requests
                  4
                from economic operators to grant or renew exemptions under the RoHS Directive (Article 5(3) and Annex V).

               On 17 July 2018, the Commission received an application for a new exemption in Annex IV to allow the continued placing on the market of spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, containing > 0.1% DEHP, BBP, DBP and DIBP by weight in homogeneous materials. According to the applicants, the reuse of spare parts containing these substances would take place in auditable closed-loop business-to-business return systems and each reuse would be notified to the consumer.

               The requested exemption goes beyond what is already allowed under the RoHS Directive (Article 4(4) and (5), Annex II), as it would involve extending the periods of the exclusions for spare parts and allowing the use of the four substances in spare parts from medical devices that have not previously been placed on the EU market.

               In November 2018, in order to evaluate the application for this new exemption, the Commission launched a study
                  5
                to carry out the required technical and scientific assessment. The study, which was concluded in 2020, included an 8‑week online stakeholder consultation, during which one contribution was received. Information concerning the consultation was provided on the project website
                  6
               .

               The Commission consulted the Member States’ expert group for delegated acts under the RoHS Directive on 23 February 2021. The Commission has taken all necessary steps relating to exemptions from the substance restriction pursuant to Article 5(3) to (7)
                  7
               . It notified the Council and the European Parliament of all activities in this context.

               The technical and scientific assessment report highlighted that:

               ·DEHP, BBP, DBP and DIBP are used as additives in polymers, adhesives, sealants, paints and lacquers to improve the properties (e.g. flexibility) of equipment (e.g. cable insulation, rubber seals) in medical devices, including in vitro diagnostic medical devices;

               ·the market for recovered spare parts for medical equipment is a global one and spare parts are collected globally for refurbishment and further distribution. Therefore, it is not feasible to distinguish spare parts by their market of origin and to determine the concentration of phthalates in a non-destructive way. Furthermore, the existing spare parts provisions do not cover the global distribution of recovered spare parts for medical equipment;

               ·the substitution of the restricted phthalates has been assessed to be both scientifically and technically practicable. However, manufacturing new parts not containing the substances, rather than reusing existing spare parts, produces carbon dioxide emissions, introduces heavy metals into the market and leads to the premature generation of hazardous and non-hazardous waste;

               ·overall, the total negative environmental, health and consumer safety impacts of substituting the four phthalates in spare parts are likely to outweigh the total benefits.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               The evaluation results show that granting this exemption would not weaken the environmental and health protection afforded by the REACH Regulation.

               Furthermore, the exemption request meets at least one of the criteria in Article 5(1)(a) of the Directive: the total negative environmental, health and consumer safety impacts of substitution are likely to outweigh the total environmental, health and consumer safety benefits.

               The 7‑year validity period for the exemption is not expected to have adverse impacts on innovation and due to a long lifetime of MRI devices, phthalate-containing spare parts will be needed in the following years. Therefore, the exemption should be granted for a period of 7 years.

               The proposed act grants an exemption from the substance restrictions in Annex II to the RoHS Directive, to be listed in its Annex IV (on exemptions specific to medical devices and monitoring and control instruments), for the use of DEHP, BBP, DBP and DIBP in specific applications.

               The instrument is a delegated directive, as provided for by the RoHS Directive and meeting the relevant requirements of its Article 5(1)(a).

               The objective of the delegated directive is to contribute to the protection of human health and the environment, and harmonise the provisions for the functioning of the internal market in the field of EEE, by allowing the use of otherwise banned substances for specific applications, in line with the RoHS Directive and the procedure established therein for the adaptation to scientific and technical progress of its Annexes III and IV.

               The delegated directive has no implications for the EU budget.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 11.8.2021

               amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment
                  8
               , and in particular Article 5(1), point (a), thereof,

               Whereas:

               (1)Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to certain exempted applications listed in Annex IV to that Directive.

               (2)The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in its Annex I.

               (3)By Commission Delegated Directive (EU) 2015/863
                  9
               , bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) were added to the list of restricted substances referred to in Annex II to Directive 2011/65/EU.

               (4)Delegated Directive (EU) 2015/863 provides that the restriction of DEHP, BBP, DBP and DIBP is not to apply to spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of medical devices, including in vitro medical devices, placed on the market before 22 July 2021.

               (5)On 17 July 2018, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV to that Directive, for the use of DEHP, BBP, DBP and DIBP in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices (‘the requested exemption’).

               (6)The evaluation of the exemption application concluded that the total negative environmental and health impacts of substituting refurbished parts containing DEHP, BBP, DBP and DIBP with new substance-free refurbished parts are likely to outweigh the total environmental and health benefits. The evaluation included stakeholder consultations required by Article 5(6) of the Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

               (7)In order to ensure a high level of protection for the environment, health and consumer safety, reuse should take place in auditable closed-loop business-to-business return systems and reuse of spare parts should be notified to the customer.

               (8)The requested exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  10
                and thus does not weaken the environmental and health protection afforded by it.

               (9)It is therefore appropriate to grant the requested exemption by including the applications covered by it in Annex IV to Directive 2011/65/EU.

               (10)The requested exemption should be granted for a duration of 7 years starting from the date of application of this Directive in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation.

               (11)Directive 2011/65/EU should therefore be amended accordingly.

               (12)In the interest of legal certainty and in order to protect the legitimate expectations of operators supplying the medical devices concerned that the requested exemption applies by the date of entry into force of the prohibition for the use of the restricted substance in question, and in the absence of any legitimate interest in creating a disruption to the supply of those medical devices as a result of the entry into force of that prohibition, this Directive should enter into force as a matter of urgency and should apply with retroactive effect from 21 July 2021,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

               Article 2

               (1)Member States shall adopt and publish, by [the last day of the 5th month after the date of entry into force of this Directive]at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall communicate the text of those provisions to the Commission forthwith.

               They shall apply those provisions from 21 July 2021.

               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               (2)Member States shall communicate to the Commission the text of the main provisions of national law that they adopt in the field covered by this Directive.

               Article 3

               This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 11.8.2021

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 174, 1.7.2011, p. 88.

                     (2)

                        OJ L 137, 4.6.2015, p. 10.

                     (3)

                        Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).

                     (4)

                  http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm
                  .

                     (5)

                        For the final report of the study, see:
                  https://op.europa.eu/en/publication-detail/-/publication/df0ab036-8b52-11ea-812f-01aa75ed71a1/language-en/format-PDF/source-146143357
                  .

                     (6)

                        Consultation period: 18 March to 17 May 2019;
                  https://rohs.exemptions.oeko.info/
                  .

                     (7)

                        A list of the required administrative steps is available on the
                  Commission website
                  . The current stage of the procedure can be viewed for each draft delegated act in the Interinstitutional Registry of Delegated Acts at
                  https://webgate.ec.europa.eu/regdel/#/home
                  .

                     (8)

                        OJ L 174, 1.7.2011, p. 88.

                     (9)

                        Commission Delegated Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances (OJ L 137, 4.6.2015, p. 10).

                     (10)

                        Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

    ---documentbreak---

               ANNEX

               In Annex IV to Directive 2011/65/EU, the following entry 47 is added:

                        ‘47

                        Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer.

                        Expires on 21 July 2028.’


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes for analysing human body fluids and/or dialysate fluids

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               This Commission Delegated Directive amends, for the purpose of adapting to technical and scientific progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)
                  1
                (the RoHS Directive) as regards an exemption for specific applications containing bis(2-ethylhexyl) phthalate (DEHP).

               Article 4 of the RoHS Directive restricts the use of certain hazardous substances in electrical and electronic equipment (EEE). Currently, 10 substances are restricted and listed in Annex II to the Directive: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis(2‑ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP). DEHP was added to the list by Commission Delegated Directive (EU) 2015/863
                  2
                and will be prohibited in medical devices covered by the RoHS Directive from 22 July 2021.

               Annexes III and IV to the RoHS Directive list the materials and components of EEE for specific applications exempted from the substance restrictions in its Article 4(1). Article 5 provides for Annexes III and IV to be adapted to scientific and technical progress (as regards the granting, renewing and revoking of exemptions). Under Article 5(1)(a), exemptions are to be included in Annexes III and IV only if this does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 (REACH)
                  3
                and any of the following conditions is fulfilled:

               –their elimination or substitution via design changes or materials and components that do not require any of the materials or substances listed in Annex II is scientifically or technically impracticable;

               –the reliability of substitutes is not ensured;

               –the total negative environmental, health and consumer safety impacts of substitution are likely to outweigh the total environmental, health and consumer safety benefits.

               Decisions on exemptions, and their duration, are to take into account the availability of substitutes and the socio‑economic impact of substitution. Decisions on the duration of exemptions must take into account any potential impact on innovation. Life-cycle thinking on the overall impacts of the exemption must apply, where relevant.

               Article 5(1) of the RoHS Directive provides for the Commission to include materials and components of EEE for specific applications in the lists in Annexes III and IV by means of individual delegated acts pursuant to Article 20. Article 5(3) and Annex V establish the procedure for submitting exemption applications.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               The Commission receives numerous requests
                  4
                from economic operators to grant or renew exemptions under the RoHS Directive (Article 5(3) and Annex V).

               On 17 July 2018, the Commission received a request for a new exemption in Annex IV to allow the placing on the market of medical devices containing >0.1% DEHP by weight in homogeneous materials in specific applications. The request concerns an exemption for the use of DEHP in ion‑selective electrodes applied in point of care analysis for medical devices.

               In November 2018, in order to evaluate the application for this new exemption, the Commission launched a study
                  5
                to carry out the required technical and scientific assessment. The study, which was concluded in 2020, involved an 8‑week online stakeholder consultation, during which one contribution was received. Information concerning the consultation was provided on the project website
                  6
               .

               The Commission consulted the Member States’ expert group for delegated acts under the RoHS Directive on 23 February 2021. Some experts expressed agreement with the drafts presented, with a large group remaining silent. The Commission has taken all necessary steps relating to exemptions from the substance restriction pursuant to Article 5(3) to (7)
                  7
               . It notified the Council and the European Parliament of all activities in this context.

               The technical and scientific assessment report highlighted that:

               ·DEHP is used as a membrane solvent for ion‑selective electrode constituents in analysers that allow the practicable and quick ‘point of care analysis’ of ionic substances present in human body fluids and/or in dialysate fluids;

               ·it would be technically feasible to substitute the membrane solvent, but current alternatives are not performing well and may inter alia have adverse socio‑economic impacts;

               ·not granting the exemption would result in the early obsolescence of around 500 t of point of care analysers that depend on ion‑selective electrodes. The environmental benefit of not placing DEHP membrane solvents on the market is relatively limited, as spent ion‑selective electrodes are medical waste and ultimately incinerated. The DEHP would not be returned to the material cycle;

               ·not granting an exemption would also place a high financial and organisational burden on healthcare facilities as a result of having to replace the point of care analysers. This could prevent or delay analyses and the health service might have to finance unplanned new equipment, resulting in unintended indirect health impacts;

               ·overall, the total negative environmental and health impacts of substituting DEHP in ion‑selective electrode constituents are likely to outweigh the total benefits;

               ·in the light of the average lifetime of ion‑selective electrode point of care analysers and the likely time required for switching to a non-DEHP market, the maximum 7‑year exemption period, as laid down in Article 5(2) of the RoHS Directive, is appropriate for these specific applications.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               While DEHP in articles is restricted by entry 51 in Annex XVII to the REACH Regulation, EEE within the scope of the RoHS Directive is exempted from that restriction. The evaluation results show that granting the exemption would not weaken the environmental and health protection afforded by REACH, thereby satisfying the condition in Article 5 of the Directive.

               Furthermore, the exemption request meets at least one of the criteria in Article 5(1)(a) of the Directive: overall, the reliability of substitutes is currently not sufficiently ensured and the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof.

               The validity period of the exemption is not expected to have adverse impacts on innovation. Therefore, the exemption should be granted for a period of 7 years.

               The proposed act grants an exemption from the substance restrictions in Annex II to the RoHS Directive, to be listed in its Annex IV (on exemptions specific to medical devices and monitoring and control instruments), for the use of DEHP in specific applications.

               The instrument is a delegated directive, as provided for in the RoHS Directive and meeting the relevant requirements of its Article 5(1)(a).

               The objective of the delegated directive is to contribute to the protection of human health and the environment, and harmonise provisions for the functioning of the internal market in the field of EEE, by allowing the use of otherwise banned substances for specific applications, in line with the RoHS Directive and the procedure established therein for the adaptation to scientific and technical progress of its Annexes III and IV.

               The delegated directive has no implications for the EU budget.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 11.8.2021

               amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in ion‑selective electrodes for analysing human body fluids and/or dialysate fluids

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment
                  8
               , and in particular Article 5(1), point (a), thereof,

               Whereas:

               (1)Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to the Directive. That restriction does not apply to certain exempted applications listed in Annex IV to the Directive.

               (2)The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in its Annex I.

               (3)Pursuant to Commission Delegated Directive (EU) 2015/863
                  9
               , bis(2-ethylhexyl) phthalate (DEHP) is a restricted substance listed in Annex II to Directive 2011/65/EU and its use is to be prohibited, from 22 July 2021, in medical devices, including in vitro medical devices above a maximum concentration value of 0,1% tolerated by weight in homogeneous materials.

               (4)On 17 July 2018, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV to that Directive, for the use of DEHP in ion selective electrodes for analysing human body fluids and/or in dialysate fluids (‘the requested exemption’).

               (5)DEHP is used as a membrane solvent of ion selective electrodes applied in point of care analysers which help to measure the concentration of ionic substances in human body fluids and/or in dialysate fluids.

               (6)A technical and scientific assessment study was carried out to evaluate the exemption application
                  10
               . The evaluation of the application concluded that alternatives to DEHP are currently not sufficiently reliable and that the substitution of DEHP in specific applications would result in negative environmental and health impacts that outweigh its benefits. The evaluation included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

               (7)The requested exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  11
                and thus does not weaken the environmental and health protection afforded by it.

               (8)It is therefore appropriate to grant the requested exemption by including the applications covered by it in Annex IV to Directive 2011/65/EU.

               (9)To provide efficient technical equipment for health services and to allow time for the development of suitable alternatives, the requested exemption should be granted for a duration of 7 years starting from the date of application of this Directive in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation.

               (10)Directive 2011/65/EU should therefore be amended accordingly.

               (11)In the interest of legal certainty and in order to protect the legitimate expectations of operators supplying the medical devices concerned that the requested exemption applies by the date of entry into force of the prohibition for the use of the restricted substance in question,  and in the absence of any legitimate interest in creating a disruption to the supply of those medical devices as a result of the entry into force of that prohibition, this Directive should enter into force as a matter of urgency and should apply with retroactive effect from 21 July 2021,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

               Article 2

               (1)Member States shall adopt and publish, by [the last day of the 5th month after the date of entry into force of this Directive]at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall communicate the text of those provisions to the Commission forthwith.

               They shall apply those provisions from 21 July 2021.

               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               (2)Member States shall communicate to the Commission the text of the main provisions of national law that they adopt in the field covered by this Directive.

               Article 3

               This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 11.8.2021

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 174, 1.7.2011, p. 88.

                     (2)

                        OJ L 137, 4.6.2015, p. 10.

                     (3)

                        Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).

                     (4)

                  http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm
                  .

                     (5)

                        For the final report of the study (Pack 17), see:
                  https://op.europa.eu/en/publication-detail/-/publication/df0ab036-8b52-11ea-812f-01aa75ed71a1/language-en/format-PDF/source-146143357
                  .

                     (6)

                        Consultation period: 18 March to 17 May 2019;
                  https://rohs.exemptions.oeko.info/
                  .

                     (7)

                        A list of the required administrative steps is available on the
                  Commission website
                  . The current stage of the procedure can be viewed for each draft delegated act in the Interinstitutional Registry of Delegated Acts at
                  https://webgate.ec.europa.eu/regdel/#/home
                  .

                     (8)

                        OJ L 174, 1.7.2011, p. 88.

                     (9)

                        Commission Delegated Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances (OJ L 137, 4.6.2015, p. 10).

                     (10)

                  Study to assess three exemption requests relating to Annex IV to Directive 2011/65/EU (Pack 17)
                  .

                     (11)

                        Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

    ---documentbreak---

               ANNEX

               In Annex IV to Directive 2011/65/EU, the following entry 45 is added:

                        ‘45

                        Bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes applied in point of care analysis of ionic substances present in human body fluids and/or in dialysate fluids

                        Expires on 21 July 2028.’