REACH Compliance Updates and Trends

AS SENTCOM PLIANCE
info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931

REACH – New SVHCS,
New AutHoriSAtioNS, New
iNterpretAtioN, New report
assent compliance

Krystal Noseworthy-BaKer
phone: 613.882.1429
krystal.baker@assentcompliance.com

custom solutions for compliance [ reach | rohs | cpsia | rsl | prop65 ]

AS SENTCOM PLIANCE

INTROduCTION TO ASSENT COMPLIANCE

assent compliance
• Consulting
• Global Requirements
• Compliance Strategies
• Regulatory Interpretations and Impacts
• IT
• Cloud Computing
• Application Design
• Operations
• Program Implementation
• Data Management

custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]

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 AgENdA
• Headlines
• Updates to REACH
• Impacts
• SVHCs
• Additions
• Upcoming Additions
• Impacts
• Authorisations
• France’s Article Interpretation
• First Report on REACH
• Enforcement
• Q&A


AS SENTCOM PLIANCE

 HEAdLINES
reach in the news
On Dec 13th, 2006 – REACH was approved Between updates to guidance, industry re-
by the European Parliament and hit the news- sponses to REACH, updates to the SVHC
wire throughout Europe and North America. Candidate List, and other regulatory devel-
opments REACH remains in the news.

substances
tIon for cHemIcal tImesofmalta.com reacH and tHe electronIcs supply cHaIn:
r eacH: a new regula –
are you ready? – eetImes – may 2008
doubts remaIn over new reacH-
eu cHemIcals
law In swItzerland – sw Indu stry could face eu
t yle rules – just-food.co
IssInf m – oct 2009
o.org
s
cals l aw
acH cHemInews | europe
rea ctIon to re bc –b tHe fIgHt to Know? substan
ces of very HIgH concern
ow under reacH
and tHe cItIzens’ rIgHt to Kn ober 2010
– european envIronmental board – oct
european parlIament approves la
w
regulatIng cHemIcals – usa today
regulatory treatm
ent of “artI cles” under reac
Icals
ul ate toxIc cHem y tImes)
dIvergence of Inte H
rules to reg
rpretatIons betw
een ecHa and
eu sets
tHe frencH comp
Ibune (n
Ional Herald tr
etent autHorIt y
– july 2011
rnat
– busIness – Inte


AS SENTCOM PLIANCE

 reach in the news (cont’d)
• China is now spending billions of dollars throughout Europe which
will exponentially increase trade between these two countries as well as
providing a substantial influx of money not only for the economy in
general but for compliance enforcement. This will also serve to increase
the impact of REACH as China and Europe will work together for
compliance optimization.

• Finally, we are seeing GMP laboratories in India being accredited by the
Organisation of Economic Cooperation and Development (OECD) in
order to reduce the cost of REACH compliance for the chemical industry.
Indian chemical exports are expected to double in the next 3 years and
REACH will impact most if not all of those exports.


AS SENTCOM PLIANCE

 wHAT dOES THIS ALL MEAN?
• REACH is going mainstream
• The more attention a regulation gets in the media, the more attention
your customers give to it
» More information requests
» Contract changes
• Compliance is mandatory to continue business
» More declaration requests
» Increased standards for declarations


AS SENTCOM PLIANCE

 SVHC BASICS
svhc basics
Article 33 – Source of compliance requirement:
Duty to communicate information on substances in articles:
1. Any supplier of an article containing a substance meeting the
criteria in Article 57 and identified in accordance with Article 59(1) in a
concentration above 0,1 % weight by weight (w/w) shall provide the
recipient of the article with sufficient information, available to the sup-
plier, to allow safe use of the article including, as a minimum, the name
of that substance.
2. On request by a consumer any supplier of an article containing a sub-
stance meeting the criteria in Article 57 and identified in accordance
with Article 59(1) in a concentration above 0,1 % weight by weight
(w/w) shall provide the consumer with sufficient information, available
to the supplier, to allow safe use of the article including, as a minimum,
the name of that substance.


AS SENTCOM PLIANCE

The relevant information shall be provided, free of charge, within 45 days of
receipt of the request.
• What does this mean?
• Once a substance has been added to the SVHC List, you must
declare its presence to your downstream users if the concentration is
above 0.1% of your products weight.
• This is to be done upon immediately for professional customers and
within 45 days from request for consumers.


AS SENTCOM PLIANCE

 SVHCs – CONSTANT uPdATES
• Current Candidate List sits at 53 substances
• There are currently 20 substances proposed for addition to the Candidate
List (proposed Aug 29th, 2011). There are also 8 substances on the Registry
of Intentions.
• The last update to the Candidate List was June 20th, 2011.
• Updates have been happening about twice a year, however this is not a firm
requirement, in fact, substances can be added MORE OFTEN.
• The head of the ECHA has stated the 136 SVHCs would be listed by
the end of 2012
• Current projections state that there should be about 74 substances
by the end of 2011
• This leaves 62 substances to be added in 2012


AS SENTCOM PLIANCE

 REACH
current svhc candidate list

substance uses/materials
Anthracene Manufacture of dyes, pyrotechnics

Hardener for epoxy resins (possible use in PCBs),
hardener in adhesives, intermediate in the manufac-
4,4’ – Diaminodiphenylmethane (MDA)
ture of high-performance polymers, preparation of
polyurethane

Plasticizer (softener) in PVC, printing inks, paper and
Dibutyl phthalate (DBP)
packaging coatings, etc…

Plasticizer (softener) of PVC, acrylics, sealants, adhe-
Benzyl butyl phthalate (BBP)
sives, inks, paints, etc..

Plasticiser in polymer products, mainly PVC, blister
Bis (2-ethyl(hexyl)phthalate) (DEHP)
packing
Gas masks, humidity indicator, dye mordant for glass
Cobalt dichloride industry, drying agent in paints, lacquers, varnishes
and printing inks, etc…


AS SENTCOM PLIANCE

Lead hydrogen arsenate Insecticides

Dying industry, printing, colored glass, insecticide,
Diarsenic pentaoxide metallurgy (to harden copper, lead or gold in alloys),
etc…

Decolorizing agent for glass and enamels, oxidizing
Diarsenic trioxide agent special glass and lead crystal formulations, weed
killers

Metal finishing, aiding corrosion resistance, chrome-
Sodium dichromate
tanning of leather, colored glass and ceramic glazes
5-tert-butyl-2,4,6-trinitro-m-xylene
Fragrance, cosmetics and soap perfumes
(musk xylene)
Hexabromocyclododecane (HBCDD) Flame retardant used in HIPS, PS insulation and
and all major diastereoisomers textiles
Manufacture of bulk, large scale chemicals.
Alkanes, C10-13, chloro (Short Chain Manufacture of rubber products. Used in adhesives,
Chlorinated Paraffins) sealants, coatings and paints, thinners, paint remov-
ers, polymer preparations and compounds.
Biocide, antimicrobial, incorporated into polymers,
Bis(tributyltin)oxide
flooring, tiles and carpeting


AS SENTCOM PLIANCE

Triethyl arsenate Intermediate for semiconductors
Anthracene oil
Anthracene oil, anthracene paste,
distn. light Manufacture of other substances – anthracene and
carbon black. Other: reducing agents in blast furnac-
Anthracene oil, anthracene-low
es, as components in bunker fuel, for impregnating,
Anthracene oil, anthracene paste sealing and corrosion protection.
Anthracene oil, anthracene paste,
anthracene fraction
Production of electrodes – industrial applications.
Other: heavy duty corrosion protection, special pur-
Pitch, coal tar, high temp.
pose paving, manufacture of other substances and the
production of clay targets.

Synthesis of polyacrylamides (used in various applica-
tions, in particular in waste water treatment and paper
Acrylamide
processing. Other: polyacrylamide gels for research
purposes, grouting agents in civil engineering.

Aluminosilicate Refractory Ceramic High-temperature insulation for industrial applica-
Fibres tions and in fire protection

Zirconia Aluminosilicate, Refractory High-temperature insulation for industrial applica-
Ceramic Fibres tions and in fire protection


AS SENTCOM PLIANCE

Production of toluene diisocyanate – used for the
manufacture of flexible polyurethane foams. Other:
2,4-Dinitrotoluene
gelatinizing-plasticizing agent for the manufacture of
explosive mixtures (e.g. forairbags in cars).

Plasticiser for nitrocellulose, cellulose ether, polyac-
Diisobutyl phthalate (DIBP) rylate, polyacetate dispersions, gelling aid in plastics,
lacquers, adhesives, explosive material and nail polish.

Manufacturing pigments and dyes, pigment or coat-
ing agent (industrial and maritime paint products),
Lead chromate embalming/restoring of art products. Other uses: de-
tergents and bleaches, photosensitive materials and
for the manufacture of pyrotechnic powder.

Colouring, painting and coating agent in sectors such
as the rubber, plastic and paints, coatings and varnish-
Lead chromate molybdate sulphate red
es industries. Other Applications – agricultural equip-
(C.I. Pigment Red104)
ment, vehicles and aircraft as well as road and airstrip
painting.

Colouring, painting and coating agent in sectors such
as the rubber, plastic and paints, coatings and varnish-
Lead sulfochromate yellow (C.I.Pigment es industries. Other Applications – agricultural equip-
Yellow 34) ment, vehicles and aircraft as well as road and airstrip
painting, camouflage and ammunition marking in the
defense area.


AS SENTCOM PLIANCE

Additive plasticiser and viscosity regulator with flame-
retarding properties for acrylic resins, polyurethane,
polyvinyl chloride and other polymers. Other appli-
Tris(2-chloroethyl)phosphate
cations – adhesives, coatings, flame resistant paints
and varnishes. Main industries – furniture, textile,
building.

Common solvent used in surface coatings such as lac-
2-Ethoxyethanol quers and paints. Other uses : varnish removers, print-
ing inks, duplicating fluids, wood stains, and epoxies.

Additive in airplane de-icing solutions. Also used as a
2-Methoxyethanol
solvent in varnishes, dyes, and resins.
Mordant in dyeing pigments, source of pure nitro-
gen in laboratory, manufacturing of chrome alum and
Ammonium dichromate
alizarin. Other uses: oil purification, leather tanning
and pyrotechnics.


AS SENTCOM PLIANCE

Antiseptic agent, insecticide, flame retardant, neutron
absorber in nuclear power plants, production of glass
Boric acid in LCD flat panel displays, ramming mass. Other
uses: manufacture of monofilament fiberglass, textile
fiberglass, lubricant in carrom boards.
Chromic acid
Intermediate in chromium plating, colored glass and
Oligomers of chromic acid and dichromic ceramic glazes, oxidizing agent, cleaning agent in lab-
acid oratory glassware.
Dichromic acid

Metal finishing, manufacture of wood preservation
products, catalyst manufacture, chromium dioxide
Chromium trioxide
manufacture and pigment manufacture. Other uses:
Chrome plating.

Cobalt(II) carbonate Pigments in glass, ceramics and paints; catalysts in the
Cobalt(II) diacetate petroleum industry especially as paint driers and trace
element additives in agriculture and medicine. Other
Cobalt(II) dinitrate uses: electroplating, storage batteries, and animal
feeds. PET and other plastics for Cobalt (II) diacetate.
Cobalt(II) sulphate


AS SENTCOM PLIANCE

Antifungal compound for fiberglass, fire retardant, in-
secticide, flux in metallurgy, texturing agent in cook-
Disodium tetraborate, anhydrous
ing. Other uses: component in detergents, cosmetics,
enamel glazes, micronutrient fertilizer.

Production of safety matches, inks, explosives, leather
Potassium chromate
tanning, wood treatment and dyeing textiles.
Preparation of chromic acid, manufacture of cement,
application in police breathalyzer tests, leather tan-
Potassium dichromate
ning, in Photography as an oxidizing agent, silver test-
ing, wood treatment.

Manufacture of chromium compounds, water and al-
cohol-based coolants, pigment formulation, mordant
Sodium chromate
for dyeing wool, wood preservative, oil well drilling
fluids and catalysts.

Flame retardant in wood, paper, cotton and other
Tetraboron disodium heptaoxide, hydrate
plant-derived materials.


AS SENTCOM PLIANCE

Industrial solvent, coffee decaffeination agent, veg-
etable oil extracting agent, volatile gas anesthetic, dry
Trichloroethylene
cleaning solvent, degreaser for metal parts, manufac-
ture of a range of fluorocarbon refrigerants.
2-EEA was used in the past as solvent and intermedi-
ate in the chemical industry. It was also used for the
formulation of paints, lacquers and varnishes for in-
dustrial use.

Based on available information, 2-EEA is still used
2-Ethoxyethyl acetate on the EU market, as solvent and for the formulation
of paints, lacquers and varnished for professional use
exclusively, but at very low volumes. These remain-
ing uses are probably very specific, as suggested, for
instance, by the following use category: Building and
repairing of ships and boats, Manufacture of aircraft
and spacecraft.


AS SENTCOM PLIANCE

According to the literature and data collected from
the consultation, strontium chromate is used by four
activity sectors:
• formulation of strontium chromate containing mix-
tures (coatings such as paints, varnishes, oil-colors,
sealants, etc.),
• industrial use of strontium chromate containing
Strontium chromate formulations (coatings and mixtures) in the aero-
nautic/aerospace sector,
formulations (coatings) in the coil coating sector of
steel and aluminum,
formulations (coatings and mixtures) in the vehicle
coating sector.


AS SENTCOM PLIANCE

“Based on information from European manufac-
turers of phthalates and The European Council for
Plasticisers and Intermediates (ECPI), the substance
seems not (anymore) to be manufactured in the EU
or imported to the EU. DHNUP in Canada is used
principally for plasticiser applications and mainly as a
1,2-Benzenedicarboxylic acid, plasticiser to PVC.

di-C7-11-branched and linear alkyl esters In Canada, DHNUP is used in polyvinyl chlorides
(PVC) and foam; automotive sealant; urethane, glass,
and transmission adhesive; roof coatings, barrier coat-
ings, exterior trim, and tarps; cement, caulk, and
sealer; and high-end luggage. After 2006, the use of
DHNUP is mainly in the plasticization of electrical
and communication wire insulation.


AS SENTCOM PLIANCE

In its hydrated form (in solution concentrations ready for end-use between 3% and 100%):
• Synthesis of hydrazine derivatives
• These may act as or find uses in products such as pharmaceuticals, agrochemicals, chemical blow-
ing agents, paints, inks and organic dyes, reagents for the treatment of nuclear reactor waste, and
others (literature provides details of a large range of different applications for derivatives, salts, etc.
of hydrazine);
• Use as a monomer in polymerisations (mostly for polyurethane coatings and adhesives);
use as a corrosion inhibitor in water treatment, mainly for the removal of dissolved oxygen and the
adjustment of pH in the feedwater of boilers as well as for the removal of solids from steam genera-
tors. The critical areas of application are nuclear and thermal power generation plants (including
water steam circulation for district heating and cooling). However, oxygen scavenging based on
hydrazine is relevant for other industry sectors that utilise steam such as paper mills, steel manu-
Hydrazine facture, production of chemicals.
• But not food generation;
• Use as a reducing agent in the deposition of metals (nickel, chromium, tin and precious metals)
on plastics and glass;
• Use as a reducing agent in precious metal and basic metal recovery from metallic salt solutions and
effluents; – use as a reducing agent in purification of chemical reagents;
• Use as a stabilising agent in aromatic amines (for subsequent paint/ink manufacture);
• Use as a laboratory chemical reagent; · in its anhydrous form (at high purity levels, >90%):
• Use as a propellant for aerospace vehicles (satellite propulsion and upper stages of satellite launchers);
• Use as a fuel in military (emergency) power units (for the F-16 fighter jets);
• Use in gas generators for submarine rescue systems


AS SENTCOM PLIANCE

Coatings – High temperature coating, urethane dis-
persions, acrylic and styrene latexes. Industrial and
consumer cleaners. Paint removers, floor strippers, graf-
fiti remover, industrial degreasing, injection head and
cast-molding equipment cleaning. Agricultural chem-
1-Methyl-2-pyrrolidone
icals – Solvent for herbicide, pesticide and fungicide
formulations. Electronics Cleaning, de-fluxing, edge
bead removal, photoresist stripping. Petrochemical
processing. Lube oil processing, natural and synthetic
gas purification. Pharmaceuticals Solvent.

Today, 1,2,3-TCP is used primarily as a building block
for the synthesis of other products, such as:
• Pesticides
1,2,3-Trichloropropane • Chlorinated solvents
• Polysulfide elastomers (cross-linking agent
• Hexafluoropropylene (cross-linking agent) approxi-
mately 90% is used as an intermediate for conver-
sion into other substances.

1,2-Benzenedicarboxylic acid, di-C6-8- The main reported uses of DIHP were: · Plasticiser in
branched alkyl esters, C7-rich PVC; · Plasticiser in sealants and printing inks.


AS SENTCOM PLIANCE

 REACH
proposals for addition to the candidate list

ec cas
substance uses/materials
number number
Used as solvent, mainly in the manufac-
ture of various substances and in the pro-
duction of fibres for clothing and other
N,N-dimethylacetamide
204-826-4 127-19-5 applications. Also used as reagent, and
(DMAC)
in products such as industrial coatings,
polyimide films, paint strippers and ink
removers.

Mainly used as initiator or booster in
detonators for both civilian and mili-
Lead diazide; Lead azide 236-542-1 13424-46-9
tary uses and as initiator in pyrotechnic
devices.

Mainly used as a primer for small calibre
and rifle ammunition. Other common
Lead styphnate 239-290-0 15245-44-0 uses are in munition pyrotechnics, pow-
der actuated devices and detonators for
civilian use.


AS SENTCOM PLIANCE

Mainly used as curing agent in resins and
in the production of polymer articles and
2,2’-dichloro-4,4’-methyl-
202-918-9 101-14-4 also for manufacture of other substances.
enedianiline (MOCA)
The substance may further be used in
construction and arts.

Mainly used as laboratory agent (in pH
indicator solutions), for the production
Phenolphthalein 201-004-7 77-09-8
of pH-indicator paper and in medicinal
products.

No registration for this substance has
been submitted to ECHA. Lead dipi-
crate is an explosive like lead diazide and
Lead dipicrate 229-335-2 6477-64-1 lead styphnate. It may be used in low
amounts in detonator mixtures togeth-
er with the two other mentioned lead
compounds.

Refractory ceramic fibres are used for
high-temperature insulation, almost
exclusively in industrial applications
Aluminosilicate Refractory (insulation of industrial furnaces and
Ceramic Fibres equipment, equipment for the automo-
tive and aircraft/aerospace industry) and
in fire protection (buildings and indus-
trial process equipment).


AS SENTCOM PLIANCE

Refractory ceramic fibres are used for
high-temperature insulation, almost
exclusively in industrial applications
Zirconia Aluminosilicate (insulation of industrial furnaces and
Refractory Ceramic Fibres equipment, equipment for the automo-
tive and aircraft/aerospace industry) and
in fire protection (buildings and indus-
trial process equipment).

Mainly used for manufacture of other
1,2-Dichloroethane; ethylene
203-458-1 107-06-2 substances. Minor uses as solvent in the
dichloride
chemical and pharmaceutical industry.

Mainly used in mixtures for metal surface
Dichromium tris(chromate) 246-356-2 24613-89-6 treatment in the aeronautic/aerospace,
steel and aluminium coating sectors.

Mainly used in coatings in the aeronau-
Potassium hydroxyoctaox-
234-329-8 11103-86-9 tic/ aerospace, steel and aluminium coil
odizincatedichromate
coating and vehicle coating sectors.
Mainly used in coatings in the vehi-
Pentazinc chromate
256-418-0 49663-84-5 cle coating and aeronautic / aerospace
octahydroxide
sectors.


AS SENTCOM PLIANCE

Pentazinc chromate

octahydroxide

Mainly used for manufacture of other
Formaldehyde, oligomeric substances. Minor uses are as hardener
reaction products with 500-036-1 25214-70-4 for epoxy resins, e.g. for the production
aniline (technical MDA) of rolls, pipes and moulds, and as well
for adhesives.

No registration for this phthalate com-
pound has been submitted to ECHA.
Hence, the substance seems not to be
Bis(2-methoxyethyl) manufactured in or imported to the EU
204-212-6 117-82-8
phthalate in quantities above 1 t/y. Main uses in
the past were as plasticiser in polymeric
materials and paints, lacquers and var-
nishes, including printing inks.

Mainly used to remove gas bubbles from
ceramic glass melt and for improving ad-
Arsenic acid 231-901-9 7778-39-4 hesion between copper foil and resin in
the production of laminated printed cir-
cuit boards


AS SENTCOM PLIANCE

Calcium arsenate is present in complex
raw materials imported for manufacture
of copper, lead and a range of precious
metals. It appears mainly to be used in
Calcium arsenate 231-904-5 7778-44-1 metallurgical refinement processes to
precipitate nickel from molten copper
and to manufacture diarsenic trioxide.
However, most of the substance seems to
be disposed of as waste.

Trilead diarsenate is present in complex
raw materials imported for manufacture
of copper, lead and a range of precious
metals. The trilead diarsenate contained
in the raw materials is in the metallur-
Trilead diarsenate 222-979-5 3687-31-8
gical refinement process transformed to
calcium arsenate and diarsenic trioxide.
Whereas most of the calcium arsenate
appears to be disposed of as waste the di-
arsenic trioxide is used further.


AS SENTCOM PLIANCE

Mainly used in the manufacture of dyes
2-Methoxyaniline;
201-963-1 90-04-0 for tattooing and coloration of paper,
o-Anisidine
polymers and aluminium foil.

Mainly used in the manufacture of poly-
4-(1,1,3,3-tetramethylbutyl) mer preparations and of ethoxylates.
205-426-2 140-66-9
phenol, (4-tert-Octylphenol) Further used as a component in adhe-
sives, coatings, inks and rubber articles.

Used primarily as a reaction solvent or
process chemical in a wide variety of ap-
plications. Used also as solvent for bat-
Bis(2-methoxyethyl) ether 203-924-4 111-96-6
tery electrolytes, and possibly in other
products such as sealants, adhesives, fu-
els and automotive care products.


AS SENTCOM PLIANCE

 REACH – COMMON SVHCS
DEHP (Bis (2-ethyl(hexyl)phthalate)
• Plasticizer in polymer products, mainly PVC, blister packing
» In Annex XIV – Sunset Date Feb 21, 2015
» Exemption for uses in the immediate packaging of medicinal
products covered under Regulation (EC) No 726/2004,
Directive 2001/82/EC, and/or Directive 2001/83/EC.

BBP (Benzyl butyl phthalate)
• Plasticizer (softener) of PVC, acrylics, sealants, adhesives, inks, paints, etc…
» Exemption for uses in the immediate packaging of medicinal
products covered under Regulation (EC) No 726/2004,
Directive 2001/82/EC, and/or Directive 2001/83/EC.
» Alternatives:


AS SENTCOM PLIANCE

DBP (Dibutyl phthalate)
• Plasticizer (softener) in PVC, printing inks, paper and
packaging coatings, etc…


» Exemption for uses in the immediate packaging of medicinal products
covered under Regulation (EC) No 726/2004, Directive 2001/82/
EC, and/or Directive 2001/83/EC.
» Alternatives:


AS SENTCOM PLIANCE

Alternatives: DEHP, DBP and BBP are frequently grouped together and
therefore the alternatives overlap
• In resilient flooring (DEHP) – plasticizers (assessment from 2005): di (2-eth-
ylhexyl) terephthalate (DEHT), di isononyl phthalate (DINP), dipropylene
glycol dibenzoate (DGD), and di (2-ethylhexyl) adipate (DEHA).

» All proposed alternatives must be assessed for various socio-economic fac-
tors; health, environment, technical criteria (are they as effective, as func-
tional?) and cost.

» 1 of the “alternatives” – DINP - is already regulated under the CPSIA in
the US and under the EU Toy Directive however the ECHA conducted
a review of new data in July 2010 and did not move forward with any
further restrictions on DINP


AS SENTCOM PLIANCE

Danish Ministry of the Environment did a fairly heavy alternatives
assessment for the three phthalates:

abbreviation chemical name cas no.
DINCH Di(isononyl) cyclohexane-1,2-dicarboxylate 166412-78-8

Nonylphenol 25154-52-3

TXIB Trimethyl pentanyl diisobutyrate 6846-50-0

TBAC Tert-butyl acetate 540-88-5

ATBC Acetyl tributyl citrate 77-90-7

DEHTP (same as DEHT) Di(2-ethyl-hexyl)terephthalate 6422-86-2

DINA diisononyl adipate ester 33703-08-1

DEHA Bis(2-ethylhexyl) adipate 103-23-1

DEHS Dioctyl sebacate 122-62-3

Bis(2-ethylhexyl)ester

DiBA Diisobutyl adipate 141-04-8

Other non-specified plasticisers


AS SENTCOM PLIANCE

 REACH – COMMON SVHCS
HBCDD (Hexabromocyclododecane)
• Flame retardant used in HIPS (High Impact Polystyrene), PS (Polystyrene)
insulation and textiles
• In Annex XIV – Sunset Date Aug 21, 2015
• Alternatives:
» The ECHA released, in the 2009 report for SVHC List candi-
dacy, that there were no suitable alternatives for HBCDD in
Expanded or Extruded Polystyrene (EPS and XPS respectively)
however there are alternative forms of insulation to be used in
place of EPS/XPS.
• Mineral wools
• Phenolic Foam (not hazardous in itself however the
manufacture is hazardous to humans)


AS SENTCOM PLIANCE

» There are commercially available alternative fire-retardants avail-
able to the use of HBCDD in HIPS and textile coatings, includ-
ing non-halogenated flame retardants that provide the same level
of fire protection and performance.
• Fire retardants in HIPS: Antimony trioxide (ATO),
Triphenyl phosphate (Chronic toxicant with effects on liver),
Decabromodiphenylether/ATO (Neurotoxicant), Decabrom-
odiphenylethane/ATO (Limited data, but likely to be of low toxicity)
• Alternatives to HIPS: Polyethylene with Magnesium Hydroxide


AS SENTCOM PLIANCE

 REACH – OTHER NOTES ON SVHCS
important note: echa Guidance on svhc documentation
“From Article 36(1)12 of the REACH Regulation it follows that downstream users (article pro-
ducers are considered also as downstream users under REACH, if they use a substance or mixture
in the production of their articles) have to keep available all the information they require to carry
out their REACH obligations. But even if it has been identified that no obligations under REACH
apply, these companies should consider documenting the results of their compliance checking. This
includes documenting the decision-making on whether certain products are articles, substances
or mixtures as well as the checking if specific requirements apply for these. Documenting this is
recommended to producers and importers of articles in general, as it facilitates demon-
strating REACH compliance towards customers and (inspecting/enforcing) authorities.”

*Note that the bolded portion above is actually bolded in the Guidance itself
to emphasize the importance of Documentation.
• The updated “Guidance in a Nutshell” was released at the end of June.
• Compact version (17 pages) of the complete guidance document
There were no huge changes from the previous guidance that would impact
a compliance plan; most of the updates now have to do with further clarity
but no large departures in policy.


AS SENTCOM PLIANCE

REACH
authorisation overview
• The Authorisation process – starts with the identification of substances of
very high concern (SVHC) by Member State Competent Authorities or
the European Chemicals Agency (on behalf of the European Commission)
by preparing a dossier in accordance with Annex XV. Decisions on priori-
tisation of these SVHCs and the subsequent release of the final list of sub-
stances subject to authorisation is decided by the Commission.

• Industry has to apply to the ECHA for authorisation for uses of these
substances. After an approval process, the holder of an authorisation can
use and place on the market the substance for the uses he was granted an
authorisation.

summary
Most, if not all, substances on the current SVHC List will eventually re-
quire an Authorisation for their use on a per substance, per company, per
use basis.


AS SENTCOM PLIANCE

 REACH
the aim of authorisation
• As per article 55 of the REACH Regulation: “the good functioning of the
internal market while assuring that the risks from substances of very high
concern are properly controlled and that these substances are progressively
replaced by suitable alternative substances or technologies where these are
economically and technically viable”.
• All Authorisation applicants shall analyse the availability of alternatives, con-
sider their risks, and the technical and economic feasibility of substitution.
• If the risk is not adequately controlled, an authorisation may still be granted
if it is proven that the socio-economic benefits outweigh the risks and there
are no suitable alternative substances or technologies.


AS SENTCOM PLIANCE

 REACH
authorisation process –
substances beinG added to the list
Authorisation Process – Annex 15 Dossiers:
1. Registry of intentions – Intention to submit dossier
2. Submission of Annex XV dossier (SVHC Dossier) to ECHA for
Compliance Check
3. Publication of Annex XV dossier (once it has passed compliance check)
4. After Commenting periods – Candidate List
(Article 33 Requirements kick in)
5. Prioritisation list – Order in which substances will be reviewed for Authorisation
6. Authorisation List – Restrictions and Authorisations handed out


AS SENTCOM PLIANCE

An Authorisation will contain the following information:
• Substance identity
• Substance intrinsic properties of very high concern,
• Sunset date, date by when a substance can no more be used
without authorisation
• Application date, date before which an application for authorisation for
each use that is not exempted from the authorisation requirement must be
made, in order to continue to use the substance for the specific use.
• Review period for uses, if appropriate
• Exempted uses or categories of uses


AS SENTCOM PLIANCE

 REACH – AuTHORISATION
process overview – application for authorisation
The ECHA published new tools for preparation and submission of
Authorisation Applications:
http://echa.europa.eu/news/na/201104/na_11_16_authorisation_applications_20110405_en.asp


AS SENTCOM PLIANCE

 REACH – AuTHORISATION
current authorisation list

substance included in annex, sunset date

4,4’ – Diaminodiphenylmethane (MDA) In Annex XIV – Sunset Date Aug 21, 2014

Dibutyl phthalate (DBP) In Annex XIV – Sunset Date Feb 21, 2015

Benzyl butyl phthalate (BBP) In Annex XIV – Sunset Date Feb 21, 2015

Bis (2-ethyl(hexyl)phthalate) (DEHP) In Annex XIV – Sunset Date Feb 21, 2015

5-tert-butyl-2,4,6-trinitro-m-xylene (musk
In Annex XIV – Sunset Date Aug 21, 2014
xylene)

Hexabromocyclododecane (HBCDD)and
In Annex XIV – Sunset Date Aug 21, 2015
all major diastereoisomers identified:


AS SENTCOM PLIANCE

 RECOMMENdEd fOR AuTHORISATION
recommended for inclusion dec 17, 2010

substances

Diarsenic pentaoxide Diarsenic trioxide

Alkanes, C10-13, chloro (Short Chain
Chlorinated Paraffins) 2,4-Dinitrotoluene
*Recommendation for inclusion June 1, 2009

Diisobutyl phthalate (DIBP) Lead chromate

Lead chromate molybdate sulphate red (C.I.
Lead sulfochromate yellow (C.I.Pigment Yellow 34)
Pigment Red104)

Tris(2-chloroethyl)phosphate

*SCCPs are already included in the Convention on Long- Range Transboundary Air Pollution and
triggers additional obligations under Regulation (EC) No 850/2004 – if further information is
required, please contact Assent.


AS SENTCOM PLIANCE

 dRAfT RECOMMENdATION fOR AuTHORISATION
comment deadline sept 14th

substances

Cobalt dichloride Sodium dichromate

Ammonium dichromate Chromic acid

Oligomers of chromic acid and dichromic
Dichromic acid
acid

Chromium trioxide Cobalt(II) carbonate

Cobalt(II) diacetate Cobalt(II) dinitrate

Cobalt(II) sulphate Potassium chromate

Potassium dichromate Sodium chromate

Trichloroethylene


AS SENTCOM PLIANCE

 wHAT dOES AuTHORISATION MEAN fOR yOu?
If a substance within your products is on the Authorisation list:
• Testing and/or creation of testing proposals
• Possible creation of a new CSR
• Analysis of Alternatives
• Substitution Plan
• Socio-Economic Analysis
Time, Expense and Expertise is required and the authorisation may not even
be granted. Furthermore, the authorisation has a set time limit; a review re-
port must be submitted at least 18 months before its expiry.
Is there another option?
• Redesign ensures that no authorizations have to be submitted.


AS SENTCOM PLIANCE

 REACH INTERPRETATION
france forGes a new path
• ECHA guidance has maintained that complex articles will be enforced upon “as
imported” or “as manufactured” and therefore each component of the article is not
assessed against the 0.1% w/w threshold individually. France has disagreed with this
interpretation since the first guidance on substances in articles was published by the
ECHA.

• France will be enforcing the 0.1% threshold for content of SVHCs (Substances of
Very High Concern) based on the “once an article, always an article approach”.

• Each component is an article before being incorporated into another article
thus the “once an article, always an article” approach.

• Austria, Belgium, Denmark, Germany, Sweden (and Norway, not a member state
but follows REACH) have yet to officially publish an enforcement policy contrary
to the ECHA but have also made it clear that they do not prescribe to the ECHA’s
article interpretation.

• There are many long and formal steps that need to be taken by the ECHA before
an infringement case is even brought against France before the EU court therefore
it cannot be assumed that this will be resolved so that all Member states are working
with the same “ECHA interpretation”.


AS SENTCOM PLIANCE

 IMPACT Of fRANCE’S ENfORCEMENT POLICy
Companies importing to the EU cannot weigh their SVHC content against
the whole complex article.

• Each component must have SVHC data – content % and weight of the
component
• Declarations must be updated
• 2 versions – one for France, one for the rest of the EU
• 1 version that contains all the necessary information

• Astronomical increase in testing costs OR
• Supplier data gathering and engineering assessments even more vital
• Data exponentially increases
• Storage and organization paramount


AS SENTCOM PLIANCE

 REACH IS wORkINg
• REACH Regulation requires a report at least every 5 years on the overall
status of the Regulation
• This report will provide information on where all stakeholders (but mostly
the ECHA) can improve
• First report released July 1, 2011 and reports on REACH and CLP.
• Examines the lessons and challenges encountered so far (3 years into
REACH, 2 years into CLP).

• Deals with everything from nanomaterials to joint registration to IT
tool support


AS SENTCOM PLIANCE

summary:
• Communication and feedback to all REACH stakeholders – registrants, third-
party contributors, helpdesk representatives – should improve which should
speed up responses and guidance.
• REACH processes and Comitology should improve which will speed up
SVHC additions, authorisation additions along with the aforemention guid-
ance updates
• Enforcement guidance and processes will hopefully be further specified (joint
registration in particular)


AS SENTCOM PLIANCE

 REACH IS wORkINg – REPORT dETAILS
• Further clarification is required around nanomaterials and how REACH
and CLP will apply
• European Commission (EC) and Member State Competent Authorities
(MSCAs) should focus some energy on enforcement surrounding the joint
registration requirement
• It was even suggested that consideration should be given to changing
the legal text to aid in enforcement
• Intermediates registration dossiers need to be brought into full compliance
– two-sided issue: regulatory action AND industry pro-actively reassess and
updating if necessary.
• Dormant pre-registrations should be deleted, Companies not intending
to register their pre-registered substances should deactivate themselves.
Optimize the use of pre-SIEFs


AS SENTCOM PLIANCE

• Many points on the ECHAs need to improve support and feedback (both
timing and content) for: third party contributions for examination of test-
ing proposals, use of IT tools, legal interpretations of outstanding issues
from the “Helpdesk” submissions.
• REACH process reviews as well as the efficiency of the Committees and
Forums associated with REACH.


AS SENTCOM PLIANCE

 REACH
enforcement – echa enforcement plans for the future
• Swedish Chemicals Agency announced the ECHA’s intention to
submit an enforcement plan to the Ministry of the Environment
at the end of 2011.Enforcement project will begin in 2012
http://www.kemi.se/templates/News____6284.aspx

• Previous enforcement process will likely be applied to SVHCs
• European-wide coordination
• Local level implementation
• REACH-IT used by local inspectors to coordinate and verify
information
• Information must be accurate, transparent and readily available


AS SENTCOM PLIANCE

Implement your compliance scheme in accordance with available Guidance
in order to protect yourself in the future.
An ECHA REACH and CLP Enforcement and Appeals Workshop is planned
for October 15th, 2011. Brainstorming sessions on enforcement, discussion
on the real issues surrounding enforcement as well as learning about the ap-
peals process with the ECHA are all on the agenda for this event. As a result,
we should see quite a bit of information and clarity on processes being released.


AS SENTCOM PLIANCE

 REACH
enforcement – danish consumer council
• Danish NGO representing the interest of Danish Consumers
http://www.forbrugerraadet.dk/english/
• Sent REACH requests to retailers across Denmark
• 40% replied in compliance with REACH
• 60% either responded late or not at all
• All late respondents were reported to the Danish EPA

Keys to a quick response:
• Restricted Substance Control policy
• Availability of internal documentation


AS SENTCOM PLIANCE

 REACH
enforcement – mobilization of etuc and emcef
• ETUC (European Trade Union Confederation) and the EMCEF (European
Chemical Workers’ Federation)

• Alerting their member organizations to alert employers to their responsi-
bilities under REACH.

• Ensures worker safety
• Ensures continued business
• Leaflet being prepared

• Full endorsement of the ECHA

REACH violations are a potential worker health and safety issue.


AS SENTCOM PLIANCE

 REACH MEMBER STATE ENfORCEMENT PENALTIES
member state penalty

Belgium Fines up to $5,385,000 – Imprisonment up to 3 years

France Fines up to $100,000 – Imprisonment up to 2 years

Germany Fines up to $135,000 – Imprisonment up to 5 years

Ireland Fine up to $4,000,000 – Imprisonment up to 2 years

Netherlands Fines up to $900,000 – Imprisonment up to 6 years

United Kingdom No limit on Fines – Imprisonment up to 2 years


AS SENTCOM PLIANCE

 REACH ENfORCEMENT – IMPACT
Stoppage at Customs is the most likely action for SVHC issues:
• Risk to business continuity
• Loss of customers
• Loss of expected product launch timelines
• Risk of financial penalty

NGO involvement will increase
• More media, more attention = more enforcement, more risk to
non-compliant businesses

Standardized enforcement across the EU
• “Quotas” will be established so all member states will be enforcing in order
to ensure safety is a priority across the EU


AS SENTCOM PLIANCE

 PRACTICAL APPLICATION
ideal Qualities of a declaration of conformity
• A declaration should ideally be part of a process that keeps all your
information current and your declarations consistent.
• Upon request, you should be able to show the following items:
• Who sent the declaration (person, not just company)
» What was the exact response
» When was it sent
» How (email, ftp, snail mail)
• What was asked of the supplier on the Declaration
» When
» How
• How these declarations are stored
• How they are verified
• How/When they are updated


AS SENTCOM PLIANCE

 TyPICAL SERVICE OffERINgS
rohs reach component enGineers
• Manage the compliance to ROHS, REACH SVHC, and JIG Level A/B standards
• Ensure compliance with regulatory agencies and compliance regulations,
including RoHS, REACH, and WEEE.
• Review and evaluate RoHS / WEEE requirements and requirement changes
as published by regulating bodies
• Supporting sourcing and selection of electronic and mechanical components
• Serve as subject matter expert on regulatory matters
• Mentoring / support of engineering team on compliance issues
• Specification and drawing review for compliance
• Obsolescence management and part substitution
• WEEE registration and reporting
• Work with suppliers on corrective actions
• More experience and less cost than hiring a full time component engineering


AS SENTCOM PLIANCE

 ROHS ANd REACH
component and product enGineerinG services
• On demand product and component engineering services
• Specializing in a wide range of compliance requirements including RoHS,
WEEE, REACH, UL, CSA, ETL, FCC, NOM, and Proposition 65.
• All component engineers have a minimum of 5 years of RoHS/
REACH experience
• On call, part time, and full time contact support available.


AS SENTCOM PLIANCE

 QuESTIONS?
Please submit your questions in writing using the Q&A tool along the top
menu tool bar.
Any questions not addressed during the Q&A portion of this
webinar will be addressed in private correspondence after the webinar.


REACH Compliance Updates and Trends

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