Enforcement Project to Check Compliance with the Obligations of Substances in Articles

Qu Jingbo, Chen chao, Shi Xiaoyu, Jin Yuhao
(PetroChina Petrochemical Research Institute)


The Forum for Exchange of Information on Enforcement of European Chemicals Agency has started the pilot project to verify compliance with the notification and communication obligations of substances in articles in REACH. The aim of the pilot project is to determine the level and reasons for non-compliance and to raise awareness of the obligations. In particular, suppliers of consumer articles will be targeted. The project is being launched as a result of national enforcement actions according to Articles 7 and 33 of the REACH Regulation, reports from authorities or NGOs, and a low number of notifications being made to ECHA. The operational phase of the project started in October 2017 and will run until the end of June 2018. A report of the results is expected to be finished by the end of November 2018.
The pilot project aims to:
● Check compliance of producers, importers and suppliers of articles with their obligations;
● Contribute to raising awareness and understanding of the legal obligations and in turn raise the level of compliance among duty holders;
● Build a better picture of the actual level of compliance by suppliers of articles;
● Identify the reasons for non-compliance and whether further actions are required (e.g. support to duty holders) by ECHA, the Commission and/or competent authorities of the Member States;
● And gather experience and establish enforcement methods for potentially checking these obligations on a larger scale in the future.
The target groups for inspection are article distributors and producers or importers of articles. Articles that are likely to contain Candidate List substances to which consumers may be exposed are a particular focus point. Examples of consumer articles that may be inspected are electrical products, building materials and interior articles. Specific substances that would be targeted in the project include:
Brominated flame retardants;
Phosphorous flame retardants;
Short-chain chloroparaffins;
Phthalates;
Aprotic polar solvents;
Perfluorinated substances; and
Phenolic benzotriazoles.
According to Article 3(3) of REACH, article means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition, such as textiles, cars, electronic chips, tires, rubber shoes, sticky stickers, toys, PVC bathing mats, marker pens, etc.
The article itself does not require registration, but if the article containing substances intended to be released and the production or import volume of more than 1t/a, it will need to register the substances intended to be released according to Article 7(1); In addition, if the article containing substances of very high concern (SVHC), and its content is more than 0.1% (w/w), it will need to notify the substance SVHC according to Article 7(2) and transmit the information in the supply chain; If the article containing restricted substances, according to the specific requirements limit, limit the use and dosage of substances; If the article containing substances in the authorization list, you need to submit an application of authorization or replace these substances.
China has exported a large number of articles to the European Union every year, and has been the focus of supervision of the European Union Member States. This can be seen from the notification results of the EU’s Rapid Alert System for dangerous non-food products; in 2016, the platform had a total of 2 044 non compliance cases, of which 1 069 were from China. It is worth noting that since 2007, our country has been accounting for more than 50% of the number of notifications, as shown in Figure 1.
The implementation of the project is a warning signal for the producers and exporters of articles, that is, the EU will continue to increase the supervision and punishment in all aspects of the supply chain. After June 1, 2018, the last registration deadline, ECHA and EU Member States will carry out strict supervision and joint enforcement. The supervision of articles will be the focus. In order to facilitate the global articles producers, importers, distributors and consumers to understand the relevant information on substances in articles, ECHA screened the substances in articles on the EU market and published a list of substances of SVHC in articles from 2013, and updated it every six months. The number of the list of substances is 168 as shown in Table 1 for now. China’s goods producers and sellers must always pay attention to the changes in the list and take measures in advance to avoid unnecessary trade losses.           

Table 1    ECHA Candidate List substances in articles

Name    CAS Number    EC Number    Name    CAS Number    EC Number    Name    CAS Number    EC Number
Bis (2-ethylhexyl)phthalate (DEHP)    204-211-0    117-81-7    2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)    239-622-4    1557
1-58-1    3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine    421-
150-7    143860
-04-2
Hexahydromethylphthalic anhydride [1],  Hexahydro-4-methylphthalic anhydride [2],  Hexahydro-1-methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] [The individual isomers [2], [3] and [4] (including their cis- and trans- stereo isomeric forms) and all possible combinations of the isomers [1] are covered by this entry]    247-094-1"243-072-0"256-356-4"260-
566-1    25550-51-0"19438-60-9"48122-14-1"57110-29-9    Cyclohexane-1,2-dicarboxylic anhydride [1],  cis-cyclohexane-1,2-dicarboxylic anhydride [2],  trans-cyclohexane-1,2-dicarboxylic anhydride [3] [The individual cis- [2] and trans- [3] isomer substances and all possible combinations of the cis- and trans-isomers [1] are covered by this entry]    201-604-
9"236-
086-3"238
-009-9    85-42-
7"13149-
00-3"141
66-21-3    4-Nonylphenol, branched and linear [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, covering also UVCB- and well-defined substances which include any of the individual isomers or a combination thereof]        
4,4’-bis(dimethylamino)benzophenone (Michler’s ketone)    202-027-5    90-94-8    4,4’-bis(dimethylamino)-4’’-(methylamino)trityl alcohol [with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2)]    209-218-2    561-41
-1    4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated [covering well-defined substances and UVCB substances, polymers and homologues]        
Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified: Alpha-hexabromocyclododecane, Beta-hexabromocyclododecane Gamma-hexabromocyclododecane    247-148-
4"221-
695-9    25637-99-4"3194-55-6"134237-50-6"134237-51-7"134237-52-8    Disodium 4-amino-3-[[4’-[(2,4-diaminophenyl)azo][1,1’-biphenyl]-4-yl]azo] -5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38)    217-710-3    1937-
37-7    Disodium 3,3’-[[1,1’-biphenyl]-4,4’-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate) (C.I. Direct Red 28)    209-
358-4    573-
58-0
Dipentyl phthalate (DPP)    205-017-9    131-18-0    2-Methoxyethanol    203-713-7    109-86-4    2-Methoxyaniline,o-Anisidine    201-
963-1    90-
04-0
Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of 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, and fulfil the three following conditions: a) oxides of aluminium and silicon are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (μm) c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight            Silicic acid (H2Si2O5), barium salt (1:1), lead-doped [with lead (Pb) content above the applicable generic concentration limit for ‘toxicity for reproduction’ Repr. 1A (CLP) or category 1 (DSD), the substance is a member of the group entry of lead compounds, with index number 082-001-00-6 in Regulation (EC) No 1272/2008]    272-271-5    68784-
75-8    Zirconia Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of 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, and fulfil the three following conditions: a) oxides of aluminium, silicon and zirconium are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (μm) c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight        
Dibutyl phthalate (DBP)    201-557-4    84-74-2    Diisobutyl phthalate    201-553-2    84-69-5    Fatty acids, C16-18, lead salts    292-
966-
7    91031
-62-8
Diazene-1,2-dicarboxamide (C,C’-azodi(formamide)) (ADCA)    204-650-8    123-77-3    4,4’- Diaminodiphenylmethane (MDA)    202-974-4    101-77-9    Formaldehyde, oligomeric reaction products with aniline    500-
036-1    25214
-70-4
5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual isomers of [1] and [2] or any combination thereof]            [4-[4,4’-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (C.I. Basic Violet 3) [with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2)]    208-953-6    548-62-9    4-Nonylphenol, branched and linear, ethoxylated [substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof]        
Boric acid    233-139-
2"234-343-4    10043-35-3"
11113-50-1    Formamide    200-842-0    75-12-7    Furan    203-
727-3    110-
00-9
Disodium tetraborate, anhydrous    215-540-4    1303-
96-4"1330
-43-4"12179
-04-3    4,4’-methylenedi-o-toluidine    212-658-8    838-88-0    Henicosafluoroundecanoic acid    218-
165-4    2058-
94-8
1-Methyl-2-pyrrolidone    212-828-1    872-50-4    4,4’-oxydianiline and its salts    202-977-0    101-80-4    Heptacosafluorotetradecanoic acid    206-
803-4    376-
06-7
Lead titanium zirconium oxide    235-727-4    12626-81-2    Lead bis(tetrafluoroborate)    237-486-0    13814-96-5    4-methyl-m-phenylenediamine (toluene-2,4-diamine)    202-
453-1    95-
80-7
Lead cyanamidate    244-073-9    20837-86-9    4-Aminoazobenzene    200-453-6    60-09-3    Hydrazine    206-
114-9    302-01
-2"7803
-57-8
Bis(pentabromophenyl) ether (decabromodiphenyl ether) (DecaBDE)    214-604-9    1163-19-5    Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins)    287-476-5    85535-
84-8    2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol (UV-328)    247-
384-8    25973-
55-1
Diboron trioxide    215-125-8    1303-86-2    Lead dinitrate    233-245-9    10099-
74-8    Lead di(acetate)    206-
104-4    301-
04-2
Lead monoxide (lead oxide)    215-267-0    1317-36-8    Orange lead (lead tetroxide)    215-235-6    1314-41-6    Lead diazide, Lead azide    236-
542-1    13424-
46-9
Lead sulfochromate yellow (C.I. Pigment Yellow 34)    215-693-7    1344-37-2    5-tert-butyl-2,4,6-trinitro-m-xylene (Musk xylene)    201-329-4    81-15-2    Lead hydrogen arsenate    232-
064-2    7784-
40-9
Imidazolidine-2-thione,(2-imidazoline-2-thiol)    202-506-9    96-45-7    6-methoxy-m-toluidine (p-cresidine)    204-419-1    120-71-8    Lead dipicrate    229-
335-2    6477-
64-1
Acids generated from chromium trioxide and their oligomers. Names of the acids and their oligomers: Chromic acid, Dichromic acid, Oligomers of chromic acid and dichromic acid.    231-801-
5"236-881-5    7738-
94-5"13
530-68-2    Lead chromate molybdate sulphate red (C.I. Pigment Red 104)    235-759-9    12656-
85-8    [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26)    219-
943-6    2580-
56-5
Lead oxide sulfate    234-853-7    12036-
76-9    [Phthalato(2-)]dioxotrilead    273-688-5    69011-06-9    Lead styphnate    239-
290-0    15245-
44-0
Benzyl butyl phthalate (BBP)    201-622-7    85-68-7    Acetic acid, lead salt, basic    257-175-3    51404-69-4    Lead titanium trioxide    235-
038-9    12060-
00-3
Pitch, coal tar, high temp.    266-028-2    65996
-93-2    Ammonium dichromate    232-143-1    7789-09-5    Lead(II) bis(methanesulfonate)    401-
750-5    17570-
76-2
2,4-Dinitrotoluene    204-450-0    121-
14-2    Acrylamide    201-173-7    79-06-1    Methoxyacetic acid    210-
894-6    625-
45-6
Lead chromate    231-846-0    7758-
97-6    Ammonium pentadecafluorooctanoate (APFO)    223-320-4    3825-26-1    N,N,N’,N’-tetramethyl-4,4’-methylenedianiline (Michler’s base)    202-
959-2    101-
61-1
N,N-dimethylacetamide    204-826-4    127-
19-5    Anthracene    204-371-1    120-12-7    N,N-dimethylformamide    200-
679-5    68-12-2
Tris(2-chloroethyl)phosphate    204-118-5    115-96-8    Anthracene oil    292-602-7    90640-
80-5    N-methylacetamide    201-
182-6    79-16-3
Methyloxirane (Propylene oxide)    200-879-2    75-56-9    Anthracene oil, anthracene paste    292-603-2    90640-
81-6    N-pentyl-isopentylphthalate        776297
-69-9
1,2-dimethoxyethane,ethylene glycol dimethyl ether (EGDME)    203-794-9    110-71-4    Anthracene oil, anthracene paste, anthracene fraction    295-275-9    91995-
15-2    Anthracene oil, anthracene paste, distn. lights    295-
278-5    91995
-17-4
2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)    223-383-8    3864-99-1    Pentadecafluorooctanoic acid (PFOA)    206-397-9    335-67-1    Perfluorononan-1-oic-acid and its sodium and ammonium salts    206-
801-3    375-95
-1"21049
-39-8"41
49-60-4
2-Ethoxyethyl acetate    203-839-2    111-15-9    Anthracene oil, anthracene-low    292-604-8    90640-
82-7    o-Toluidine    202-
429-0    95-53-4
4-(1,1,3,3-tetramethylbutyl)phenol    205-426-2    140-66-9    Arsenic acid    231-901-9    7778-39-4    Pentacosafluorotridecanoic acid    276-
745-2    72629
-94-8
Bis(tributyltin) oxide (TBTO)    200-268-0    56-35-9    Biphenyl-4-ylamine    202-177-1    92-67-1    o-aminoazotoluene    202-
591-2    97-56-3
Cadmium    231-152-8    7440-43-9    Bis(2-methoxyethyl) ether    203-924-4    111-96-6    Pentalead tetraoxide sulphate    235-
067-7    12065
-90-6
Diarsenic pentaoxide    215-116-9    1303-28-2    Bis(2-methoxyethyl) phthalate    204-212-6    117-82-8    Pentazinc chromate octahydroxide    256-
418-0    49663
-84-5
2-Ethoxyethanol    203-804-1    110-80-5    Cadmium chloride    233-296-7    10108-64-2    Nitrobenzene    202-
716-0    98-95-3
Sodium chromate    231-889-5    7775-11-3    Cadmium fluoride    232-222-0    7790-79-6    Phenolphthalein    201-
004-7    77-09-8
Trichloroethylene    201-167-4    79-01-6    Cadmium oxide    215-146-2    1306-19-0    Potassium chromate    232-
140-5    7789-
00-6
Trilead dioxide phosphonate    235-252-2    12141-20-7    Cadmium sulphate    233-331-6    10124-36-
4"31119-
53-6    Potassium dichromate    231-
906-6    7778-
50-9
Trixylyl phosphate    246-677-8    25155-23-1    Cadmium sulphide    215-147-8    1306-23-6    Potassium hydroxyoctaoxodizincatedichromate    234-
329-8    11103
-86-9
Chromium trioxide    215-607-8    1333-82-0    Cobalt dichloride    231-589-4    7646-79-9    Silicic acid, lead salt    234-
363-3    11120
-22-2
1,2,3-trichloropropane    202-486-1    96-18-4    Calcium arsenate    231-904-5    7778-44-1    Pyrochlore, antimony lead yellow    232-
382-1    8012-
00-8
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)            1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters or mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)    271-094-
0"272-013
-1    68515-51-
5"68648-
93-1    α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol (C.I. Solvent Blue 4) [with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2)]    229-
851-8    6786
-83-0
1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich    276-158-1    71888-89-6    1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters    271-084-6    68515-42-4    1,2-Benzenedicarboxylic acid, dihexylester, branched and linear    271-
093-5    68515
-50-4
Cobalt(II) carbonate    208-169-4    513-79-1    Cobalt(II) diacetate    200-755-8    71-48-7    Sodium dichromate    234-
190-3    7789-
12-0"
10588-
01-9
1,2-Benzenedicarboxylic acid, dipentylester, branched and linear    284-032-2    84777-06-0    Cobalt(II) dinitrate    233-402-1    10141-05-6    Sodium perborate,perboric acid, sodium salt    239-172
-9"234-
390-0    15120
-21-5
1,2-bis(2-methoxyethoxy)ethane (TEGDME,triglyme)    203-977-3    112-49-2    Cobalt(II) sulphate    233-334-2    10124-43-3    Sodium peroxometaborate    231-
556-4    7632
-04-4
1,2-Dichloroethane    203-458-1    107-06-2    Tetraethyllead    201-075-4    78-00-2    Strontium chromate    232-
142-6    7789
-06-2
1,2-Diethoxyethane    211-076-1    629-14-1    Diarsenic trioxide    215-481-4    1327-53-3    Sulfurous acid, lead salt, dibasic    263-
467-1    62229
-08-7
Dichromium tris(chromate)    246-356-2    24613-89-6    Dibutyltin dichloride (DBTC)    211-670-0    683-18-1    Tetraboron disodium heptaoxide, hydrate    235-
541-3    12267
-73-1
1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (β-TGIC)    423-400-0    59653-74-6    2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)    253-037-1    36437-37-3    1,3,5-Tris(oxiran-2-ylmethyl)-1,3,5-triazinane-2,4,6-trione (TGIC)    219-
514-3    2451
-62-9
1,3-propanesultone    214-317-9    1120-71-4    Diethyl sulphate    200-589-6    64-67-5    Tetralead trioxide sulphate    235-
380-9    12202
-17-4
1-bromopropane (n-propyl bromide)    203-445-0    106-94-5    Dihexyl phthalate    201-559-5    84-75-3    Tricosafluorododecanoic acid    206-
203-2    307-
55-1
2,2’-dichloro-4,4’-methylenedianiline    202-918-9    101-14-4    Diisopentyl phthalate    210-088-4    605-50-5    Triethyl arsenate    427-
700-2    15606
-95-8
Trilead diarsenate    222-979-5    3687-31-8    Dimethyl sulphate    201-058-1    77-78-1    Trilead bis(carbonate) dihydroxide    215-
290-6    1319
-46-6
2-benzotriazol-2-yl-4,6-di-tert-butylphenol (UV-320)    223-346-6    3846-71-7    Dinoseb (6-sec-butyl-2,4-dinitrophenol)    201-861-7    88-85-7    Dioxobis(stearato)trilead    235-
702-8    12578
-12-0