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Page 1: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

www.aepcindia.com

Page 2: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

Registration deadline for importing/manufacturing 1,000 tonnes SVHC per year

Registration deadline for importing/manufacturing 100 - 1,000 tonnesSVHC per year

Registration deadline forimporting/manufacturing1 - 100 tonnes SVHC peryear

REACHenteredinto force

Pre-Registration period

1 June2007

1 June2008

1 Dec.2008

30 Nov.2010

31 May2013

31 May2018

REACH Implementation TimelineREACH Implementation Timeline

Page 3: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

REACH Regulation requires information on substances REACH Regulation requires information on substances contained in/ used in the manufacturing of articles. contained in/ used in the manufacturing of articles.

When supplying/ exporting apparel to EU, the article from When supplying/ exporting apparel to EU, the article from REACH point of view would include the product itself and the REACH point of view would include the product itself and the packaging. packaging.

The main suppliers to the EU are in Asia (with India and The main suppliers to the EU are in Asia (with India and China being one of the major suppliers) Turkey and China being one of the major suppliers) Turkey and Switzerland. Switzerland.

In case the exporter exports jeans having buttons, buckles, In case the exporter exports jeans having buttons, buckles, Zips, etc. then each of these parts when placed in EU market Zips, etc. then each of these parts when placed in EU market will individually be treated as articles within REACHwill individually be treated as articles within REACH. .

Page 4: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

An object which during production is given a special An object which during production is given a special shape, surface or design which determines its function shape, surface or design which determines its function to a greater degree than its chemical composition to a greater degree than its chemical composition (REACH Article 3)(REACH Article 3)

An article is composed of one or more substances or An article is composed of one or more substances or preparationspreparations

Specific substances may be added to give the article Specific substances may be added to give the article

special propertiesspecial properties

Examples Examples furniture, clothes, vehicles, toys furniture, clothes, vehicles, toys

Page 5: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

A ScenarioA ScenarioA Swedish retailer buys ladies top with a plastic belt from an A Swedish retailer buys ladies top with a plastic belt from an Indian based garment company with an own production site Indian based garment company with an own production site in India.in India.

The retailer asks the garment manufacturer to sign a The retailer asks the garment manufacturer to sign a declaration that his products are REACH compliant.declaration that his products are REACH compliant.

The garment manufacturer is sure that he is not using any The garment manufacturer is sure that he is not using any chemicals in his factory and signs the declaration.chemicals in his factory and signs the declaration.

Neither the retailer nor the garment manufacturer have any Neither the retailer nor the garment manufacturer have any idea if this product might be affected by the REACH directiveidea if this product might be affected by the REACH directive

The quality department makes a chemical analysis on The quality department makes a chemical analysis on Phthalates (Phthalates are additives which give to resins Phthalates (Phthalates are additives which give to resins and plastics elasticity and softness) within regular quality and plastics elasticity and softness) within regular quality checks on samples taken from the stores.checks on samples taken from the stores.

Page 6: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

Result:Result:

••Nothing was detected in the TopNothing was detected in the Top

• • High concentration of 4.5 % (w/w) of Phthalates in High concentration of 4.5 % (w/w) of Phthalates in the belt restricted by the REACH the belt restricted by the REACH directive.directive.

Page 7: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

Paintin pot

Fire cracker Spray

can

Carbattery Perfumed

eraser

Thermo-meter

Page 8: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

The risk factors Phthalates are giving increasing concern as potential

endocrine modulators, toxic for reproduction and carcinogenic.

Three phthalates are on the REACH Candidate List identified as Substances of Very High Concern.

Actions taken by the retailer The retailer recalls the products from the POS, belts are

removed in the Swedish warehouse and goods are re-distributed to the stores.

The retailer claims the total costs including sales loss from the supplier.

The retailer gives a warning to the supplier because he considers him responsible based on signed declaration.

The belts will be dumped

Page 9: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

Check if Artical 6 or Article 30(4) may apply

Producer or importer of articals

Defination of intended release Annex 1

Is there an intended release from the article ?

Dose the article contain SVHC

SVHC defination Annex 1 Identify in article Chapter 5.4

No further action needed

Check if registration is required

Check if Art 30(4) applies and if notification is required

No

Yes Yes

Workflow 2 Workflow 3

Page 10: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

Substances, mixtures and articles can be contained inside of Substances, mixtures and articles can be contained inside of packaging, such as a carton, a plastic wrapping or a tin can. The packaging, such as a carton, a plastic wrapping or a tin can. The packaging does not belong to the substance, mixture or article being packaging does not belong to the substance, mixture or article being packaged and is therefore to be considered as a separate article packaged and is therefore to be considered as a separate article under REACH.under REACH.

The obligation to notifyThe obligation to notify substances in articles also applies to substances in articles also applies to packaging materials, which may be produced or exported separately packaging materials, which may be produced or exported separately as packaging of exported goods.as packaging of exported goods.

The The obligations to communicateobligations to communicate information on substances in articles information on substances in articles also apply to packaging materials.also apply to packaging materials.

Packaging with different functions Packaging with different functions needs to be considered separatelyneeds to be considered separately Examples of the materials and substance used in packaging include: Examples of the materials and substance used in packaging include:

paper, metal, inks, adhesives, glass, coatings, plastics, board, foil, paper, metal, inks, adhesives, glass, coatings, plastics, board, foil, drums etc. drums etc.

Page 11: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

A substance may be proposed as an SVHC if it meets one or more ofthe following criteria: it is carcinogenic

it is mutagenic

it is toxic for reproduction

it is persistent, bioaccumulative and toxic according to the criteria set in our Annex XIII to the REACH Regulation (PBT substances)

it is very persistent and very bioaccumulative according to the criteria set our in Annex XIII to the REACH Regulation (vPvB substances)

there is "scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern" such substances are identified on a case-by-case basis

Page 12: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

In October 2008 the first version of the candidate list In October 2008 the first version of the candidate list containing 15 Substances of Very High Concern were containing 15 Substances of Very High Concern were published. Since then more substances have been included, published. Since then more substances have been included, and today the list has 46 items.and today the list has 46 items.

A substance of very high concern (SVHC) is a chemical A substance of very high concern (SVHC) is a chemical substance (or part of a group of chemical substances) for substance (or part of a group of chemical substances) for which it has been proposed that the use within the European which it has been proposed that the use within the European Union be subject to authorisation under the REACH Union be subject to authorisation under the REACH Regulation.Regulation.

The listing of a substance as an SVHC by the European The listing of a substance as an SVHC by the European Chemicals Agency (ECHA) is the first step in the procedure for Chemicals Agency (ECHA) is the first step in the procedure for authorisation and restriction of use of a chemical. authorisation and restriction of use of a chemical.

Page 13: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

Seven new substances have been added to the Candidate List of Substances of Very High Concern (SVHC) for authorisation. Companies manufacturing or importing these substances, or articles containing the substances, need to check their potential obligations that result from the listing.

The List now contain 53 substances in total.

Visit the below web-site to see the updated candidate list http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

Page 14: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

S.NO.S.NO. Substance NameSubstance Name EC No./CAS No.EC No./CAS No. Application AreasApplication Areas

11 Dibutyl phthalateDibutyl phthalate 201-557-4/201-557-4/

84-74-284-74-2Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks

& stockings of knitwear, track suits, t-shirts 7 singlets, work & protection clothes for Men.& stockings of knitwear, track suits, t-shirts 7 singlets, work & protection clothes for Men.

22 Bis (2-ethyl (hexyl) Bis (2-ethyl (hexyl)

phthalate) (DEHP)phthalate) (DEHP)204-211-0/117-81-204-211-0/117-81-

77Softener in Polymers and Synthetical resinSoftener in Polymers and Synthetical resin

33 HexabromocyclododecanHexabromocyclododecan

e (HBCDD)e (HBCDD)247-148-4/247-148-4/

25637-99-425637-99-4Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks

& stockings of knitwear, track suits, t-shirts & singlets, work & protection clothes for men& stockings of knitwear, track suits, t-shirts & singlets, work & protection clothes for men

44 Alkanes, C10-13, chloro Alkanes, C10-13, chloro

(short chain chlorinated (short chain chlorinated

Paraffins)Paraffins)

55 Bis(tributyltin)oxideBis(tributyltin)oxide 200-268-0/200-268-0/

56-35-956-35-9Biocide in anti-mould couloursBiocide in anti-mould coulours

66 Benzyl butyl phthalateBenzyl butyl phthalate 201-622-7/201-622-7/

85-68-785-68-7Softner in polymers and synthetic resinSoftner in polymers and synthetic resin

77 Sodium dichromate, Sodium dichromate,

dehydrated (CMR)dehydrated (CMR)234-190-3/234-190-3/

10588-01-910588-01-9Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks

& stockings of knitwear, track suits, t-shirts & singlets, work & protection clothes for men& stockings of knitwear, track suits, t-shirts & singlets, work & protection clothes for men

88 AnthraceneAnthracene 204-371-1/204-371-1/

120-12-7120-12-7Textile mordantTextile mordant

99 Cobalt dichlorideCobalt dichloride 231-589-4/231-589-4/

7646-79-97646-79-9Mordant dyeMordant dye

1010 Diars pentaoxideDiars pentaoxide 215-116-9/215-116-9/

1303-28-21303-28-2Colouring industry, preserver.Colouring industry, preserver.

1111 Potassium dichromatePotassium dichromate 231-906-0/231-906-0/

7778-50-97778-50-9Clothes of coaed textile, dresses, pullover, vests etc., overcoats & jackets, ski suits, socks & Clothes of coaed textile, dresses, pullover, vests etc., overcoats & jackets, ski suits, socks &

stockings of knitwear, track suits, t-shirts & singlets, work & protection clothes for menstockings of knitwear, track suits, t-shirts & singlets, work & protection clothes for men

1212 Tris(2-chloroethyl) Tris(2-chloroethyl)

phosphatephosphate204-118-5/204-118-5/

115-96-8115-96-8Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks

& stockings of knitwear, track suits, t-shirts & singlets& stockings of knitwear, track suits, t-shirts & singlets

1313 Lead Sulfochromate Lead Sulfochromate

yellow (C.I. Pigment Red yellow (C.I. Pigment Red

104)104)

215-693-7/215-693-7/

1344-37-21344-37-2Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks

& stockings of knitwear, track suits, t-shirts & singlets& stockings of knitwear, track suits, t-shirts & singlets

1414 Lead chromate molybdate Lead chromate molybdate

sulphate red (C.I. Pigment sulphate red (C.I. Pigment

Red 104)Red 104)

235-759-9/235-759-9/

12656-85-812656-85-8Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks Clothes of coated textile, dresses, jerseys, pullovers, vests etc., overcoats & jackets, ski suits, socks

& stockings of knitwear, track suits, t-shirts & singlets, work & protection clothes for men& stockings of knitwear, track suits, t-shirts & singlets, work & protection clothes for men

1515 4,4’- 4,4’-

DiaminodiphenylmethaneDiaminodiphenylmethane202-974-4/202-974-4/

101-77-9101-77-9Raw Material for the production of “ Methylendiphenyldiisocyanat” for PUR (main application) Epoxi Raw Material for the production of “ Methylendiphenyldiisocyanat” for PUR (main application) Epoxi

resin, adhesivesresin, adhesives

Page 15: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

REACH has selected a few substances which are considered to be highly REACH has selected a few substances which are considered to be highly hazardous as compared to the other SVHC substances from the candidate list. hazardous as compared to the other SVHC substances from the candidate list. These are hazardous substances listed as These are hazardous substances listed as substances or Authorizationsubstances or Authorization. .

In case a substance present in a textile product is a member of the authorization In case a substance present in a textile product is a member of the authorization list then a suitable alternative has to be found within the period provided by the list then a suitable alternative has to be found within the period provided by the agency.agency.

The list of chemicals that needs authorization and are currently used in the The list of chemicals that needs authorization and are currently used in the textile sector are given below:textile sector are given below:

S.No.S.No. Substance NameSubstance Name EC No.EC No.

11 4,4’- Diaminodiphenylmethane4,4’- Diaminodiphenylmethane 202-974-4202-974-4

22 Dibutyl phthalateDibutyl phthalate 201-557-4201-557-4

33 Bis (2-ethyl(hexyl)phthalate) (DEHP)Bis (2-ethyl(hexyl)phthalate) (DEHP) 204-211-0204-211-0

44 Hexabromocyclododecane (HBCDD)Hexabromocyclododecane (HBCDD) 247-148-4247-148-4

55 Benzyl butyl phthalateBenzyl butyl phthalate 201-622-7201-622-7

Page 16: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

Asbestos compounds (asbestos)Asbestos compounds (asbestos) Pesticide compounds (biocides)Pesticide compounds (biocides) Dioxins and Furans (dioxins and furans)Dioxins and Furans (dioxins and furans) Azo dyes (dyes)Azo dyes (dyes) Disperse dyes (dyes)Disperse dyes (dyes) Flame retardants compounds (flameFlame retardants compounds (flame retardants)retardants) Formaldehyde (formaldehyde)Formaldehyde (formaldehyde) F-gases (greenhouse gases)F-gases (greenhouse gases) Arsenic compounds (Metals)Arsenic compounds (Metals) Cadmium compounds (Metals)Cadmium compounds (Metals) Chromium compounds (Metals)Chromium compounds (Metals) Lead compounds (Metals)Lead compounds (Metals) Mercury compounds (Metals)Mercury compounds (Metals) Nickel compounds (Metals)Nickel compounds (Metals) Organostannic compounds (organo tin)Organostannic compounds (organo tin) Ozone depleting BCMs (ozone depletingOzone depleting BCMs (ozone depleting substances)substances) Ozone depleting CFCs (ozone depleting substances)Ozone depleting CFCs (ozone depleting substances) Ozone depleting halons (ozone depleting substances)Ozone depleting halons (ozone depleting substances) Ozone depleting HBFCs (ozone depleting substances)Ozone depleting HBFCs (ozone depleting substances) Ozone depleting HCFCs (ozone depleting substances)Ozone depleting HCFCs (ozone depleting substances) Ozone depleting methyl bromide (ozone depletingOzone depleting methyl bromide (ozone depleting substances)substances) Ozone depleting solvents (ozone depleting substances)Ozone depleting solvents (ozone depleting substances)

Page 17: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

The importers or suppliers are considered to be non-compliant and has infringed the The importers or suppliers are considered to be non-compliant and has infringed the REACH provisions, if they fail to register; fail to notify ECHA in advance; not be able to REACH provisions, if they fail to register; fail to notify ECHA in advance; not be able to provide sufficient information to their customers or cannot disclose the presence of provide sufficient information to their customers or cannot disclose the presence of SVHC in products within 45 days upon request from consumers. The importer or supplier SVHC in products within 45 days upon request from consumers. The importer or supplier is subject to the following penalty:is subject to the following penalty:

EU MemberEU MemberStateState

Max. PenaltyMax. Penalty EU MemberEU MemberStateState

Max. PenaltyMax. Penalty

AustriaAustria € € 38,00038,000 BulgariaBulgaria € € 51,12951,129

CyprusCyprus € € 80,000 and 4 years of prison80,000 and 4 years of prison FranceFrance € € 75,000 and 2 years of prison75,000 and 2 years of prison

GermanyGermany Sentenced to a fineSentenced to a fine GreeceGreece € € 35,00035,000

HungaryHungary € € 70,42770,427 IrelandIreland € € 3,000,000 or/and 2 years or 3,000,000 or/and 2 years or prisonprison

ItalyItaly € € 150,000 or 3 months of 150,000 or 3 months of prisonprison

LiechtensteinLiechtenstein € € 131,863 or/and 6 months of 131,863 or/and 6 months of prisonprison

LithuaniaLithuania € € 4,3504,350 LuxembourgLuxembourg € € 50,000 or/and 3 years of prison50,000 or/and 3 years of prison

NetherlandsNetherlands € € 740,000 or/and 740,000 or/and 6 years of prison6 years of prison

PolandPoland € € 4,761,905 or/and 2 years of 4,761,905 or/and 2 years of prisonprison

PortugalPortugal € € 2,500,0002,500,000 RomaniaRomania € € 11,88911,889

SlovakiaSlovakia € € 99,58199,581 SloveniaSlovenia € € 60,00060,000

SpainSpain € € 1,200,0001,200,000 UKUK Unlimited fine or/and 2 years of Unlimited fine or/and 2 years of prisonprison

Page 18: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

have to bear all related costshave to bear all related costs

does not know which products can contain regulated does not know which products can contain regulated chemical ingredients or componentschemical ingredients or components

cannot afford neither financially nor time wise to have all cannot afford neither financially nor time wise to have all products tested continuously and repeatedly on substances products tested continuously and repeatedly on substances of the REACH candidate list.of the REACH candidate list.

does not know which information and when he has to does not know which information and when he has to provide to his customer.provide to his customer.

risks future orders from the customer.risks future orders from the customer.

Page 19: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

REACH requires a registration of chemical substances REACH requires a registration of chemical substances produced or imported in quantities from 1 ton per year (t/a) in produced or imported in quantities from 1 ton per year (t/a) in a central database.a central database.

Technical dossiers containing the basic attributes of chemicalTechnical dossiers containing the basic attributes of chemical substances, their classification and labelling as well as their substances, their classification and labelling as well as their

purpose of use and guidelines for safe handling have to be purpose of use and guidelines for safe handling have to be provided for registration. provided for registration.

The main focus of REACH is to accompany and to assure the The main focus of REACH is to accompany and to assure the complete way of a substance through all production complete way of a substance through all production processes e.g. - processes e.g. - from the raw material to the final productfrom the raw material to the final product

Page 20: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

The regulation does not require registration and testing The regulation does not require registration and testing of of preparations (e.g. dye stuffs, textile auxiliaries etc.) or preparations (e.g. dye stuffs, textile auxiliaries etc.) or products (e.g. textiles, garments, shoes etc.)products (e.g. textiles, garments, shoes etc.)

However, garment exporters are liable to give However, garment exporters are liable to give information on the article being exported from June information on the article being exported from June 20112011

Page 21: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100
Page 22: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

THINKTHINK! If substances of very high concern are used in ! If substances of very high concern are used in production, then how to control them or find substitutes.production, then how to control them or find substitutes.

Be Be InformedInformed! Control their use if they are part of the ! Control their use if they are part of the preparations used in production.preparations used in production.

Get Get AwareAware! If components or packaging material contain ! If components or packaging material contain these substances , then find a way out to control themthese substances , then find a way out to control them

IdentifyIdentify the components and materials to be checked the components and materials to be checked

Control Control critical components and substances critical components and substances

Page 23: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

ShareShare the liability with all responsible partners in the supply the liability with all responsible partners in the supply chain.chain.

AchieveAchieve safety Precautionary Principles. safety Precautionary Principles.

Attain Attain information on risks and hazards availableinformation on risks and hazards available

Achieve knowledge on quality and all-over performance Achieve knowledge on quality and all-over performance (Environment, H&S, Product Safety etc.) through (Environment, H&S, Product Safety etc.) through transparency on suppliers and componentstransparency on suppliers and components

ProvideProvide quick response to customers on REACH compliance quick response to customers on REACH compliance

AttainAttain overall cost reductions & improvement of quality overall cost reductions & improvement of quality aspects and product safety through supply chain transparency aspects and product safety through supply chain transparency

and lean supply chain managementand lean supply chain management

Page 24: Www.aepcindia.com. Registration deadline for importing/ manufacturing 1,000 tonnes SVHC per year Registration deadline for importing/ manufacturing 100

AEPC HELPDESKAEPC HELPDESK

The AEPC website carries a manual on REACHThe AEPC website carries a manual on REACH

The FAQ section also carries common queries on The FAQ section also carries common queries on REACHREACH

You can post your queries or know more about the You can post your queries or know more about the forthcoming seminars on REACH at forthcoming seminars on REACH at [email protected] or call at [email protected] or call at 0124-2708035

Send us your queries with your name and contact Send us your queries with your name and contact details and do visit- www.aepcindia.com details and do visit- www.aepcindia.com