title: COMMISSION DIRECTIVE (EU) .../… amending Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council for the purpose of adopting specific limit values for chemicals used in certain toys, as regards formaldehyde

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

               of 19.11.2019

               amending Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council for the purpose of adopting specific limit values for chemicals used in certain toys, as regards formaldehyde

                (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 Article 46(2) thereof,

               Whereas:

               (1)Directive 2009/48/EC establishes certain requirements for chemical substances that are classified as carcinogenic, mutagenic or toxic for reproduction under Regulation (EC) No 1272/2008 of the European Parliament and of the Council
                  2
               . Appendix C to Annex II to the Directive lays down specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth.

               (2)Formaldehyde (CAS number 50-00-0) is currently not listed in Appendix C to Annex II to Directive 2009/48/EC. It is classified as carcinogenic category 1B under Regulation (EC) No 1272/2008. Pursuant to point 4(a) of Part III of Annex II to Directive 2009/48/EC, formaldehyde may be used up to a concentration of 0,1 %, which corresponds to 1000 mg/kg (content limit).

               (3)In order to advise the Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission has established the Expert Group on Toys Safety
                  3
               . The mission of its subgroup Working group on Chemicals in Toys (subgroup Chemicals) is to provide advice to the Expert Group on Toys Safety with regard to chemical substances which may be used in toys.

               (4)Formaldehyde is used as a monomer in the manufacture of polymeric materials. Polymeric materials are often used in toys. Children may therefore ingest formaldehyde when mouthing toys containing polymeric materials. The tolerable daily intake (TDI) for formaldehyde was set by the World Health Organisation (WHO)
                  4
                and has been confirmed by the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) of the European Food Safety Authority
                  5
               . The TDI is0,15 mg/kg bodyweight per day. With an allocation of 10 % of the TDI to the intake of formaldehyde from toys
                  6
               ,, a child with a bodyweight of 10 kg should therefore not take in more than 0,15 mg formaldehyde per day. Assuming a daily ingestion of 100 ml of mouthing saliva, the subgroup Chemicals recommended, at its meeting on 26 September 2017
                  7
               , a formaldehyde migration limit of 1,5 mg/l in polymeric materials when the migration of formaldehyde is determined in accordance with the test method in standards EN 71-10:2005
                  8
                and EN 71-11:2005
                  9
               .

               (5)Formaldehyde is also used in the manufacture of resin-bonded wood products such as particle board, oriented-strand board (OSB), high-density fibre board (HDF), medium density fibre board (MDF) and plywood. Formaldehyde resins include phenol-formaldehyde (PF), urea-formaldehyde (UF), melamine-formaldehyde (MF) and polyacetal (polyoxymethylene - POM) resins. POM tends to be used only for small internal components and not in whole toys. The subgroup Chemicals recommended, at its meeting on 26 September 2017, a formaldehyde emission limit of 0,1 ml/m3 when the emission of formaldehyde is determined in such materials in accordance with the test chamber method in standard EN 717-1:2004
                  10
               . That limit corresponds to the indoor air limit value that the WHO has established to prevent sensory irritation in the general population and to prevent cancer
                  11
               .

               (6)Formaldehyde may also be present in textile toy material due to its use during the manufacture of textiles. According to a report from the Organisation for Economic Cooperation and Development (OECD) published in 2002, the lowest threshold concentration for allergic contact dermatitis from formaldehyde is 30 mg/kg
                  12
               . On that basis and in order to protect also the most sensitised individuals, the subgroup Chemicals recommended, at its meeting on 26 September 2017, a formaldehyde content limit of 30 mg/kg when the content of formaldehyde is determined in accordance with the water extraction method in standard EN ISO 14184-1:2011
                  13
               .

               (7)Formaldehyde may be present in leather toy material due to its use during the manufacture of leather. Since leather toy material may lead to an exposure similar to textile toy material the subgroup Chemicals recommended, at its meeting on 26 September 2017, a formaldehyde content limit of 30 mg/kg when the content of formaldehyde is determined in accordance with standard EN ISO 17226-1:2008
                  14
               .

               (8)Formaldehyde in paper toy material should have a content limit of 30 mg/kg according to the recommendation of the subgroup Chemicals at its meeting on 26 September 2017, when determined in accordance with the water extraction method in standard EN 645:1993
                  15
                and with standard EN 1541:2001
                  16
               . That conclusion was based on the consideration that paper toy material may lead to an exposure similar to textile and leather toy material.

               (9)Formaldehyde may be present in water-based toy material due to its function as a preservative. It could be used in water-based toy materials such as soap bubbles or inks in felt-tip pens, and also in dry materials intended to be mixed with water prior to use. In light of the opinion of the Scientific Committee on Health and Environmental Risks (SCHER) that CMR compounds should not be present in toys
                  17
               , the subgroup Chemicals recommended, at its meeting on 3 May 2018
                  18
               , a formaldehyde limit of 10 mg/kg in water-based toy material when the content of formaldehyde is determined according to the test method published by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (the EDQM method) on the Determination of free formaldehyde in cosmetic products
                  19
               . The recommended limit is close to the lowest value that can be reliably determined by the EDQM method and takes account of traces of formaldehyde that certain other preservatives may release.

               (10)The Expert Group on Toys Safety took note, at is meeting on 19 December 2017
                  20
               , of the recommendations of its subgroup Chemicals regarding the limits for formaldehyde in different toy materials. It expressed support and suggested a number of improvements for the Commission to consider.

               (11)Pursuant to Article 46(2) of Directive 2009/48/EC, the packaging requirements for food as laid down in Regulation (EC) No 1935/2004 are to be taken into account when adopting specific limit values for chemicals in Appendix C to that Directive The basic assumptions behind the specific migration limit for formaldehyde as a monomer in plastic food contact material
                  21
                are, however, different from the basic assumptions behind the recommended migration limit for formaldehyde as a monomer in toys. Therefore, it is not possible to take account of the packaging requirements for food when setting a limit for formaldehyde as a monomer in toys..

               (12)In light of the available scientific evidence and the recommendations of the Expert Group on Toys Safety and its subgroup Chemicals, it is necessary to set the recommended limits for formaldehyde in different toy materials.

               (13)Appendix C to Annex II to Directive 2009/48/EC should therefore be amended accordingly.

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

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               In Appendix C to Annex II to Directive 2009/48/EC, the following entry is added:

                        Substance

                        CAS No

                        Limit value

                        ‘Formaldehyde

                        50-00-0

                        1,5 mg/l (migration limit) in polymeric toy material

                        0,1 ml/m3 (emission limit) in resin-bonded wood toy material

                        30 mg/kg (content limit) in textile toy material

                        30 mg/kg (content limit) in leather toy material

                        30 mg/kg (content limit) in paper toy material

                        10 mg/kg (content limit) in water-based toy material.’

               Article 2

               1.Member States shall adopt and publish, by [Insert here the date that is 18 months after the 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 [Insert here the date that is 18 months + 1 day after the 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, 19.11.2019

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 170, 30.6.2009, p. 1.

                     (2)

                        Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

                     (3)

                        Register of Commission Expert Groups, Expert Group on Toys Safety (E01360).

                  http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=1360

                     (4)

                        WHO  (1993)  Guidelines  for  drinking-water  quality.  Second  Edition.  World  Health  Organisation. Geneva. p. 98.

                     (5)

                  https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2007.415
                  . Referred to in the position paper of the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) for the subgroup Chemicals EXP/WG/2016/041.

                     (6)

                        Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE). Opinion on "Assessment of the bioavailability of certain elements in toys". Adopted on 22 June 2004.

                  http://ec.europa.eu/health/archive/ph_risk/committees/sct/documents/out235_en.pdf

                        Scientific Committee on Health and Environmental Risks (SCHER). Opinion on "Risk from organic CMR substances in toys". Adopted on 18 May 2010.
                        Scientific Committee on Health and Environmental Risks (SCHER). Opinion on "Evaluation of the migration limits for chemical elements in Toys". Adopted on 1 July 2010.

                     (7)

                        Register of Commission Expert Groups, Expert Group on Toys Safety (E01360), tab ‘Meetings’.
                  http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=4151
                  . The limit value was included in meeting document EXP/WG/2017/023.

                     (8)

                        Safety of toys - Part 10: Organic chemical compounds – Sample preparation and extraction.

                     (9)

                        Safety of toys - Part 11: Organic chemical compounds – Methods of analysis.

                     (10)

                        Wood-based panels - Determination of formaldehyde release - Part 1: Formaldehyde emission by the chamber method.

                     (11)

                        World Health Organisation (WHO) 2010, WHO guidelines for indoor air quality: selected pollutants. P. 140-142.
                  http://www.euro.who.int/__data/assets/pdf_file/0009/128169/e94535.pdf

                     (12)

                        EXP/WG/2016/058.

                     (13)

                        Textiles - Determination of formaldehyde - Part 1: Free and hydrolysed formaldehyde (water extraction method) (ISO 14184-1:2011).

                     (14)

                        Leather - Chemical determination of formaldehyde content – Part 1: Method using high performance liquid chromatography (ISO 17226-1:2008).

                     (15)

                        Paper and board intended to come into contact with foodstuffs - Preparation of a cold water extract.

                     (16)

                        Paper and board intended to come into contact with foodstuffs - Determination of formaldehyde in an aqueous extract.

                     (17)

                        Scientific Committee on Health and Environmental Risks (SCHER). CEN's response to the opinion of the CSTEE on the assessment of CEN report on the risk assessment of organic chemicals in toys. Adopted on 29.5.2007.

                  http://ec.europa.eu/health/archive/ph_risk/committees/04_scher/docs/scher_o_056.pdf

                     (18)

                        Register of Commission Expert Groups, Expert Group on Toys Safety (E01360), tab ‘Meetings’.
                  http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=6870
                  .

                     (19)

                  https://www.edqm.eu/en/cosmetics-testing

                     (20)

                        Register of Commission Expert Groups, Expert Group on Toys Safety (E01360), tab ‘Meetings’.
                  http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=1485

                     (21)

                        Entry 15 in Table 2 of Annex I of Regulation (EU) No 10/2011. OJ L12, 15.1.2011, p. 1.


title: COMMISSION DIRECTIVE (EU) .../… amending, for the purpose of its adaptation to technical progress, the Annex to Council Directive 80/181/EEC as regards the definitions of SI base units

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

               of 23.7.2019

               amending, for the purpose of its adaptation to technical progress, the Annex to Council Directive 80/181/EEC as regards the definitions of SI base units

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

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

               Having regard to Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control
                  1
               , in particular Article 16 thereof,

               Whereas:

               (1)Council Directive 80/181/EEC
                  2
                defines the units of measurement to be used in the Union thus enabling to express measurements and indications of quantity in line with the International System of Units (SI), adopted by the General Conference on Weights and Measures (CGPM) set up by the Metre Convention signed in Paris on 20 May 1875.

               (2)Directive 2009/34/EC sets out the general framework for the adoption of separate Directives concerning, amongst others, measuring instruments and their technical requirements, units of measurement and the harmonisation of methods of measurement and metrological control. Article 16 of that Directive envisages that the Commission may amend the annexes to the separate Directives referred to in its Article 1 for the purpose of adaptation to technical progress, including Chapter I of the Annex to Directive 80/181/EEC.

               (3)The CGPM decided, at its 24th meeting in 2011, on a new way of defining the SI based on a set of seven defining constants drawn from the fundamental constants of physics and other constants of nature. This decision was confirmed at the 25th meeting of the CGPM in 2014.

               (4)On the 26th meeting of the CGPM in 2018, new definitions of the SI base units were adopted. The new definitions are based on the new principle of fixed numerical values of the defining constants and will be effective as from 20 May 2019. The new definitions are expected to improve the long-term stability and reliability of the SI base units as well as the accuracy and clarity of measurements.

               (5)The new definitions adopted by the CGPM reflect the latest developments in measurement science and standards. In order to adapt the definitions of the SI base units set out in Directive 80/181/EEC to technical progress and thus contribute to the uniform implementation of the SI, it is necessary to align them with the new definitions.

               (6)Directive 80/181/EEC should therefore be amended accordingly.

               (7)It is necessary to ensure that the new legislation applies as from the same date for all Member States, independently of the date of transposition, so that uniform implementation of Directive 80/181/EEC is in place.

               (8)The measures provided for in this Directive are in accordance with the opinion of the Committee for Adjustment to Technical Progress of the Directives referred to in Article 16 of Directive 2009/34/EC,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1
                  Amendment

               The Annex to Directive 80/181/EEC is amended in accordance with the Annex to this Directive.

               Article 2
                  Transposition

               1.Member States shall adopt and publish, by … [9 months from the 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 … [10 months from the entry into force of this Directive].

               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
                  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.

               This Directive is addressed to the Member States.

               Done at Brussels, 23.7.2019

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 106, 28.4.2009, p.7.

                     (2)

                        Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40).

    ---documentbreak---

               ANNEX

               In the Annex, Chapter I, section 1.1 is replaced by the following:

               "1.1. SI base units

                        Quantity

                        Unit

                        Name

                        Symbol

                        Time

                        second

                        s

                        Length

                        metre

                        m

                        Mass

                        kilogram

                        kg

                        Electric current

                        ampere

                        A

                        Thermodynamic temperature

                        kelvin

                        K

                        Amount of substance

                        mole

                        mol

                        Luminous intensity

                        candela

                        cd

               Definitions of SI base units:

               Unit of time

                  The second, symbol s, is the SI unit of time. It is defined by taking the fixed numerical value of the caesium frequency ΔvCs, the unperturbed ground-state hyperfine transition frequency of the caesium 133 atom, to be 9 192 631 770 when expressed in the unit Hz, which is equal to s-1.

               Unit of length

                  The metre, symbol m, is the SI unit of length. It is defined by taking the fixed numerical value of the speed of light in vacuum c to be 299 792 458 when expressed in the unit m/s, where the second is defined in terms of ΔvCs.

               Unit of mass

                  The kilogram, symbol kg, is the SI unit of mass. It is defined by taking the fixed numerical value of the Planck constant h to be 6.626 070 15 x 10-34  when expressed in the unit J s, which is equal to kg m2 s-1, where the metre and the second are defined in terms of c and ΔvCs.

                     Unit of electric current

                  The ampere, symbol A, is the SI unit of electric current. It is defined by taking the fixed numerical value of the elementary charge e to be 1.602 176 634 x 10-19 when expressed in the unit C, which is equal to A s, where the second is defined in terms of ΔvCs.

                  Unit of thermodynamic temperature

                  The kelvin, symbol K, is the SI unit of thermodynamic temperature. It is defined by taking the fixed numerical value of the Boltzmann constant k to be 1.380 649 x 10-23 when expressed in the unit J K-1, which is equal to kg m2 s-2 K-1, where the kilogram, metre and second are defined in terms of h, c and ΔvCs.

                  Unit of amount of substance

               The mole, symbol mol, is the SI unit of amount of substance. One mole contains exactly 6.022 140 76 x 1023 elementary entities. This number is the fixed numerical value of the Avogadro constant, NA, when expressed in the unit mol-1 and is called the Avogadro number.

               The amount of substance, symbol n, of a system is a measure of the number of specified elementary entities. An elementary entity may be an atom, a molecule, an ion, an electron, any other particle or specified group of particles.

                  Unit of luminous intensity

                  The candela, symbol cd, is the SI unit of luminous intensity in a given direction. It is defined by taking the fixed numerical value of the luminous efficacy of monochromatic radiation of frequency 540 x 1012 Hz, Kcd, to be 683 when expressed in the unit lm W-1, which is equal to cd sr W-1, or cd sr kg-1 m-2  s3, where the kilogram, metre and second are defined in terms of h, c and ΔvCs.

                  1.1.1.
                     Special name and symbol of the SI derived unit of temperature for expressing Celsius temperature

                        Quantity

                        Unit

                        Name

                        Symbol

                        Celsius temperature

                        degree Celsius

                        °C

               Celsius temperature t is defined as the difference t = T – T0 between the two thermodynamic temperatures T and T0  where T0  = 273,15 K. An interval or difference of temperature may be expressed either in kelvins or in degrees Celsius. The unit ‘degree Celsius’ is equal to the unit ‘kelvin’."


title: COMMISSION DIRECTIVE (EU) .../… amending Annex II to Directive 2009/48/EC of the European Parliament and of the Council as regards the prohibition 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 prohibition 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 prohibition of 55 allergenic fragrances in toys, as listed in the table in the first paragraph of point 11 of Part III of Annex II to that Directive, in order to protect children from allergies that those fragrances can cause when used in toys.

               (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.

               (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)Directive 2009/48/EC allows the Commission to prohibit or to require labelling of allergenic fragrances in toys. Contrary to Regulation (EC) No 1223/2009 of the European Parliament and of the Council
                  5
               , which regulates cosmetic products, it does not allow the Commission to set maximum limits for allergenic fragrances.

               (7)In its opinion of 26 and 27 June 2012 the SCCS concluded that cosmetic products containing atranol or chloroatranol are not safe. The SCCS thus confirmed the opinion of the Scientific Committee on Consumer Products (SCCP) of 7 December 2004
                  6
                that atranol and chloroatranol should not be present in consumer products. The subgroup Chemicals therefore recommended, at its meeting on 3 May 2018
                  7
               , to prohibit the use of atranol and chloroatranol in toys, by adding them to the table in the first paragraph of point 11 of Part III of Annex II to Directive 2009/48/EC.

               (8)In its opinion of December 1999
                  8
               , the Scientific Committee on Cosmetic Products and non-food Products intended for Consumers (SCCNFP), which was a predecessor of the SCCS, included methyl heptine carbonate among the fragrance chemicals less frequently reported as contact allergens. On the basis of that opinion, methyl heptine carbonate was included among the allergenic fragrances that have to be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, in accordance with the third paragraph of point 11 of Part III of Annex II to Directive 2009/48/EC. In its opinion of 25 September 2001
                  9
               , the SCCNFP recommended that the level of methyl heptine carbonate in finished cosmetic products should not exceed 0,01 %.

               (9)Considering the above, and in particular the SCCS opinion concluding that cosmetic products containing atranol or chloroatranol are not safe, the SCCP opinion that atranol and chloroatranol should not be present in consumer products and the SCCNFP opinion that methyl heptine carbonate should not exceed 0,01 % in cosmetic products, the Expert Group on Toys Safety recommended, at its meeting on 13 September 2019, to prohibit the use of atranol, chloroatranol and methyl heptine carbonate in toys.

               (10)In light of the opinions of the SCCS, the SCCP and the SCCNFP, and of the recommendation of the Expert Group on Toys Safety the use of atranol, chloroatranol and methyl heptine carbonate in toys should be prohibited.

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

               (12)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)

                        Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

                     (6)

                        SCCP opinion on on atranol and chloroatranol present in natural extracts (e.g. oak moss and tree moss extract), 7 December 2004 (SCCP/00847/04).

                  https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_006.pdf

                     (7)

                        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

                     (8)

                        Opinion concerning Fragrance Allergy in Consumers – A review of the problem. Analysis of the need for appropriate consumer information and identification of consumer allergens, 8 December 1999 (SCCNFP/0017/98 Final), Table 6b, p. 23.

                  https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out98_en.pdf

                     (9)

                        Opinion concerning An initial List of Perfumery Materials which must not form Part of Cosmetic Products except subject to the Restrictions and Conditions laid down, 25 September 2001 (SCCNFP/0392/00 final), p. 8.

                  https://ec.europa.eu/health/ph_risk/committees/sccp/documents/out150_en.pdf

    ---documentbreak---

               ANNEX

               In Part III of Annex II, point 11 is amended as follows:

               (1)in the first paragraph, in the table, the following entries are added:

                                 No

                                 Name of the allergenic fragrance

                                 CAS number

                                 ‘(56)

                                 Atranol (2,6-Dihydroxy-4-methyl-benzaldehyde)

                                 526-37-4

                                 (57)

                                 Chloroatranol (3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde)

                                 57074-21-2

                                 (58)

                                 Methyl heptine carbonate

                                 111-12-6’;

               (2)in the third paragraph, in the table, entry 10 is deleted.


title: COMMISSION DIRECTIVE (EU) .../… amending, for the purposes of adaptation to technical and scientific developments, point 13 of part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards aluminium

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

               of 18.11.2019

               amending, for the purposes of adaptation to technical and scientific developments, point 13 of part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards aluminium

               (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 Article 46(1)(b) thereof,

               Whereas:

               (1)Directive 2009/48/EC of the European Parliament and of the Council lays down migration limits for aluminium from toys or components of toys. Currently, the limits for aluminium are 5 625 mg/kg for dry, brittle, powder-like or pliable toy material, 1 406 mg/kg for liquid or sticky toy material and 70 000 mg/kg for scraped-off toy material.

               (2)The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has reviewed the available data on the toxicity of aluminium, taking into account the different tolerable intake levels for aluminium established by the European Food Safety Authority in 2008
                  2
                and by the Joint FAO/WHO Expert Committee on Food Additives in 2011
                  3
               . The SCHEER considered, in its 'Final opinion on tolerable intake of aluminium with regard to adapting the migration limits for aluminium in toys', adopted on 28 September 2017, a tolerable daily intake (TDI) of 0,3 mg/kg body weight per day as an appropriate base for revising the migration limits for aluminium from toys.

               (3)Since children are exposed to aluminium also through sources other than toys, only a certain percentage of the TDI should be allocated to the exposure from toys when calculating the limits. The maximum contribution from toys to the daily intake recommended by the Scientific Committee on Toxicity, Ecotoxicity and the Environment in its 2004 opinion
                  4
                is 10 %. In 2010, this percentage was confirmed by the Scientific Committee on Health and Environmental Risks in its opinion on 'Risk from organic CMR substances in toys'
                  5
                and in its opinion on 'Evaluation of the migration limits for chemical elements in toys'
                  6
               .

               (4)The SCHEER applied 10 % of the TDI, multiplied by the average weight of a child under three years of age (estimated at 7,5 kg) and divided by the daily quantity of toy material ingested. That quantity was estimated at 100 mg/day for dry, brittle, powder-like or pliable toy material, 400 mg/day for liquid or sticky toy material and 8 mg/day for scraped-off toy material. On the basis of that calculation, the SCHEER proposed revised migration limits for aluminium from toys of 2 250 mg/kg for dry, brittle, powder-like or pliable toy material, 560 mg/kg for liquid or sticky toy material and 28 130 mg/kg for scraped-off toy material (‘the proposed migration limits’).

               (5)Compliance with the proposed migration limits can be verified with the test method set out in European standard EN 71-3:2013+A3:2018, the reference of which has been published in the Official Journal of the European Union
                  7
               . The proposed migration limits can be easily enforced, since they are several thousand times higher than the lowest concentration that can be reliably quantified with the test method set out in the standard
                  8
               .

               (6)In order to advise the Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission established the Expert Group on Toys Safety
                  9
               . The mission of its subgroup Working Group on chemicals in toys (subgroup Chemicals) is to provide advice to the Expert Group on Toys Safety with regard to chemical substances that may be used in toys.

               (7)The subgroup Chemicals considered, at its meeting on 26 September 2017, that the migration limits proposed by SCHEER were appropriate.

               (8)Market surveillance data on aluminium in toys
                  10
               ,
                  11
               ,
                  12
               ,
                  13
                from approximately 5 800 tests has showed compliance with the proposed migration limits in almost all cases. Data from writing instrument manufacturers on approximately 250 samples
                  14
                has suggested that a substantial part of the writing materials are already compliant with those limits.

               (9)The Expert Group on Toys Safety agreed, at its meeting on 19 December 2017, that the migration limits for aluminium should be amended as proposed.

               (10)In light of the available scientific evidence, the opinion of the SCHEER, the data provided by the Member States and the writing materials industry and the recommendations from the Expert Group on Toys Safety and its subgroup chemicals, it is necessary to adapt the current migration limits for aluminium from toys or components of toys to technical and scientific developments by replacing them with the proposed migration limits.

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

               (12)The measures provided for in this Directive are in accordance with the opinion of the Toy Safety Committee,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               In point 13 of part III of Annex II to Directive 2009/48/EC, in the table, the entry for aluminium is replaced by the following:

                        Element

                        mg/kg
                           in dry, brittle, powder-like or pliable toy material

                        mg/kg
                           in liquid or sticky toy material

                        mg/kg
                           in scraped-off toy material

                        ‘Aluminium

                        2 250

                        560

                        28 130'

               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, 18.11.2019

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 170, 30.6.2009, p. 1.

                     (2)

                        European Food Safety Authority (EFSA), Safety of aluminium from dietary intake - Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC). Opinion adopted on 22 May 2008. The EFSA Journal (2008)  754, p. 1-34.
                  http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/754.pdf

                     (3)

                        WHO (2011) Technical Report 966 – Evaluation of certain food additives and contaminants. 74th report of the Joint FAO/WHO Expert Committee on Food Additives. P. 16.

                  http://apps.who.int/iris/bitstream/10665/44788/1/WHO_TRS_966_eng.pdf

                     (4)

                        Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE). Opinion on "Assessment of the bioavailability of certain elements in toys". Adopted on 22 June 2004.

                  http://ec.europa.eu/health/archive/ph_risk/committees/sct/documents/out235_en.pdf

                     (5)

                        Scientific Committee on Health and Environmental Risks (SCHER). Opinion on "Risk from organic CMR substances in toys". Adopted on 18 May 2010.

                     (6)

                        Scientific Committee on Health and Environmental Risks (SCHER). Opinion on "Evaluation of the migration limits for chemical elements in Toys". Adopted on 1 July 2010.

                     (7)

                        OJ C 282, 10.08.2018, p.3.

                     (8)

                        See table E.5 in EN 71-3:2013+A3:2018.

                     (9)

                        See Register of Commission Expert Groups, Expert Group on Toys Safety (E01360).

                  http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=1360

                     (10)

                        Nederlandse Voedsel- en Warenautoriteit, Geverfd houten speelgoed 2016. (Dutch Food and Product Authority, Painted wooden toys 2016).
                  https://www.inspectieresultaten.nvwa.nl/productonderzoek/geverfd-houten-speelgoed-0

                     (11)

                        Finnish Customs Laboratory, Market surveillance data from Finland for aluminium. Submission to the subgroup 'Chemicals' as EXP/WG/2017/039 in the follow-up to the meeting on 26 September 2017.

                     (12)

                        Results of market surveillance in France. Submission to the subgroup 'Chemicals' as a follow-up to the meeting on 26 September 2017.

                     (13)

                        Results of market surveillance in Austria. Submission to the subgroup 'Chemicals' as a follow-up to the meeting on 26 September 2017.

                     (14)

                        Data provided by the European Writing Manufacturers Association (EWIMA). Submission to the subgroup 'Chemicals' as a follow-up to the meeting on 26 September 2017.


title: COMMISSION DIRECTIVE (EU) .../… amending Directive 2009/48/EC of the European Parliament and of the Council as regards specific limit values for aniline in certain toys

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

               of 3.6.2021

               amending Directive 2009/48/EC of the European Parliament and of the Council as regards specific limit values for aniline in certain 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 Article 46(2) thereof,

               Whereas:

               (1)Directive 2009/48/EC establishes certain requirements for chemical substances that are classified as carcinogenic, mutagenic or toxic for reproduction under Regulation (EC) No 1272/2008 of the European Parliament and of the Council
                  2
               . Appendix C to Annex II to Directive 2009/48/EC lays down specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth.

               (2)Aniline (CAS number 62-53-3) is classified as carcinogenic category 2 and mutagenic category 2 under Regulation (EC) No 1272/2008
                  3
               . According to point 5(a) of Part III of Annex II to Directive 2009/48/EC, carcinogenic substances of category 2, such as aniline, may be used in toys in individual concentrations equal to or smaller than the relevant concentration established in Regulation (EC) No 1272/2008 for the classification of mixtures containing those substances, namely 1 %
                  4
               , which corresponds to 10 000 mg/kg ('content limit'). The same content limit applies to mutagenic substances of category 2
                  5
               .

               (3)The Scientific Committee on Health and Environmental Risks (SCHER) considered, in its opinion of 29 May 2007, that compounds that are carcinogenic, mutagenic or toxic for reproduction (CMR) should not be present in toys
                  6
               . The European Union Risk Assessment Report on aniline
                  7
                concluded that for consumers there is a need for limiting the health risks associated with the use of products containing aniline. That conclusion was based on ‘concerns for mutagenicity and carcinogenicity as a consequence of exposure arising from use of products containing the substance, as aniline is identified as a non-threshold carcinogen.’ The Committee for Risk Assessment of the European Chemicals Agency (RAC) indicated, in its opinion on restriction of substances in tattoo inks and permanent make-up
                  8
               , that aniline is considered a non-threshold carcinogen. Aniline may therefore cause cancer at even the slightest level of exposure.

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

               (5)During the meeting of the subgroup Chemicals on 18 February 2015
                  9
               , several of its members indicated that aniline could be found in coloured toy material such as textiles or leather when that material is subjected to the reductive cleavage test provided for in Appendix 10 to Regulation 1907/2006 of the European Parliament and of the Council
                  10
               . The occurrence of aniline in textiles after reductive cleavage testing was confirmed in a study carried out in  Sweden
                  11
                as a follow-up to the meeting of the Expert Group on Toys Safety on 8 June 2015. Out of 23 textile samples, aniline was identified in one red textile (4 % of all samples) at 91 mg/kg. The occurrence of aniline in clothing after reductive cleavage testing was confirmed in a study with 153 samples
                  12
               . Aniline was identified in 9 samples (6 % of all samples) at up to 588 mg/kg. Moreover, aniline has been found in a finger paint after reductive cleavage according to a German consumer magazine
                  13
               . The subgroup Chemicals  also noted, by written correspondence to the Commission in May 2020, that free aniline could be present in finger paints as an impurity of the colourants in such paints.

               (6)At the meeting of the Expert Group on Toys Safety on 8 June 2015, Germany presented a position paper providing a scientific assessment of the toxicological properties of aniline
                  14
               . According to that assessment, the existing content limit for aniline presents a risk for both the systemic and the cancer effects of that substance. The subgroup Chemicals concluded, at its meeting on 26 September 2017
                  15
               , that a restriction for aniline in toys should target toys and toy components of textile and leather, and finger paints, since too little information was available so far on the need  for  an  aniline  restriction in toys or toy materials other than textile, leather and finger paints. The subgroup also indicated that the limit value should be 30 mg/kg after reductive cleavage. That value is the lowest concentration that the reductive cleavage test can reliably identify. As regards finger paints, the subgroup indicated that a limit of 10 mg/kg for free aniline should be set since that is the lowest concentration that can reliably be checked in routine tests of finger paints.

               (7)The Expert Group on Toys Safety, at its meeting on 19 December 2017
                  16
               , examined the setting of limit values of 30 mg/kg for aniline after reductive cleavage in toy materials of textile and leather; of 30 mg/kg for aniline after reductive cleavage in finger paints; and of 10 mg/kg for free aniline in finger paints, as indicated earlier by the subgroup Chemicals.

               (8)Pursuant to Article 46(2) of Directive 2009/48/EC, the packaging requirements for food laid down in Regulation (EC) No 1935/2004 of the European Parliament and of the Council
                  17
                are to be taken into account when adopting specific limit values for chemicals in Appendix C to that Directive. The basic assumptions behind the migration test methods referred to in Article 11(4) of Commission Regulation (EU) No 10/2011
                  18
               , which is a specific measure within the meaning of Article 5 of Regulation (EC) No 1935/2004 and which establishes specific requirements for the manufacture and marketing of plastic materials and articles intended to come into contact with food, are however different from the basic assumptions behind the content limits for aniline in certain toys in Directive 2009/48/EC. In addition, it is impossible to compare migration limits with content limits. Therefore, further to these conclusions there is no way to take account of the packaging requirements for food when setting content limits for aniline in certain toys.

               (9)In light of the classification of aniline as a CMR substance, the European Union Risk Assessment Report on aniline, the opinion of RAC and SCHER and the opinions of the Expert Group in Toys Safety and its subgroup Chemicals as well as the studies on the presence of aniline in textiles, it is necessary to set a limit for aniline in textile toy material and leather toy material of 30 mg/kg after reductive cleavage and a limit for aniline in finger paints of 10 mg/kg as free aniline and 30 mg/kg after reductive cleavage.

               (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 Toy Safety Committee,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               In Appendix C to Annex II to Directive 2009/48/EC, the following entry is added:

                        Substance

                        CAS No

                        Limit value

                        'Aniline

                        62-53-3

                        30 mg/kg
                              after reductive cleavage in textile toy material and leather toy material

                        10 mg/kg
                              as free aniline in finger paints

                        30 mg/kg
                              after reductive cleavage in finger paints'

               Article 2

               1.Member States shall adopt and publish, by [Insert here the date 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 [Insert here the date 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, 3.6.2021

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 170, 30.6.2009, p. 1.

                     (2)

                        Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

                     (3)

                        Table 3 in Annex VI to Regulation (EC) No 1272/2008.

                     (4)

                        Table 3.6.2 in Annex I to Regulation (EC) No 1272/2008.

                     (5)

                        Table 3.5.2 in Annex I to Regulation (EC) No 1272/2008.

                     (6)

                        Scientific Committee on Health and Environmental Risks (SCHER). CEN's response to the opinion of the CSTEE on the assessment of CEN report on the risk assessment of organic chemicals in toys. Adopted on 29.5.2007.

                  http://ec.europa.eu/health/archive/ph_risk/committees/04_scher/docs/scher_o_056.pdf

                     (7)

                        European Chemicals Bureau, Institute for Health and Consumer Protection, 2004. EUR 21092 EN. Section 5.2.1.2, p. 180.

                  https://echa.europa.eu/documents/10162/6434698/orats_final_rar_aniline_en.pdf/0abd36ad-53de-4b0f-b258-10cf90f90493

                     (8)

                        Committee for Risk Assessment (RAC), Committee for Socio-economic Analysis (SEAC), Opinion on an Annex XV dossier proposing restriction on substances used in tattoo inks and permanent make-up. Adopted on 20 November 2018. Appendix 2, section 2, p. 90.

                  https://echa.europa.eu/documents/10162/2b4533af-f717-4bff-939b-2320fb43b462

                     (9)

                        See Register of Commission Expert Groups, Expert Group on Toys Safety (E01360).

                  https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetailDoc&id=20916&no=1

                     (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).

                     (11)

                        Meeting document of the subgroup Chemicals: EXP/WG/2015/027/Ann1, Aniline from azodye cleavage, Results from Sweden.

                     (12)

                        Brüschweiler et al., Identification of non-regulated aromatic amines of toxicological concern which can be cleaved from azo dyes used in clothing textiles, Regulatory Toxicology and Pharmacology 69 (2014) 263–272. Cited in: ANEC – Position paper on aniline. April 2016. Presented to the subgroup "Chemicals" meeting on 1 June 2016 (EXP/WG/2016/027).

                     (13)

                        Ökotest 2/2015, p. 69.

                     (14)

                        Discussion paper EXP/2015/029/rev1.

                     (15)

                        Register of Commission Expert Groups, Expert Group on Toys Safety (E01360).
                  http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=4151
                  .

                     (16)

                        Register of Commission Expert Groups, Expert Group on Toys Safety (E01360), tab ‘Meetings’.
                  http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=1485
                  .

                     (17)

                        Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338 13.11.2004, p. 4).

                     (18)

                        Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 012 15.1.2011, p. 1).