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Ing. Jana Minaříková Ing. Martin Němec [email protected] XXIV. IFATCC 15.06.2016 Pardubice The future of organic colorants in Czech Republic, influence of EU legislation, end-users requirements and standards

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Ing. Jana MinaříkováIng. Martin Ně[email protected] XXIV. IFATCC15.06.2016Pardubice

The future of organic colorants in Czech Republic, influence of EU legislation, end-users requirements and standards

Synthesia, a.s.

Is the major European producer of qualified chemistry

With 1625 employees, turnover 125 million EUR and almost 95 years long tradition produce hundreds of product for customers in 60 countries all over the world

Consists of:- SBU Pigments and Dyes – production of organic pigments and dyes- SBU Nitrocellulose- SBU Organic Chemistry- SBU Energetics

Is the one of the last producer of organic dyes in Europe

Dyestuffs application groups and changes through the decades.

The sale proportion of dyes and pigments

Dyestuffs application groups and changes through the decades.

Production TurnoverDyes1 400 t 13 mil. EURPigments3 100 t 44 mil. EUR

The reasons of the changes:

- Import of the cheap textile goods and dyes from Asia

- Pigments = more qualified chemistry

REACH regulation, influences on productions of colorants, SVHC substances

CLP issues, substances mixtures formation, properties combinations eventuating classification

ETAD – code and principles, cooperation in chains to users and retailer

ZDHC and MRSL issues

Latest development in global sales and producers network in-groups (Inditex, OekoTex, GOTS etc.)

The topics which have influence on the production of organic dyes

REACH regulation, influences on productions of colorants, SVHC substances.

is a European Union regulation dated 18 December 2006. The purpose of this regulation is toprotect human health and the environment. REACH requires manufacturers and importers ofchemical substances (quantities of one tone or more per year per company) to register thesubstances in the European Chemicals Agency (ECHA). The registrations are accomplished inphases depending on tonnage and have a great impact on the textile and leather industry.

The first registration deadlinewas in December 2010 when allthe substances above 1,000tones in addition to all thecarcinogenic, mutagenic or toxicfor reproduction substances (=1 tone/year) and substancesclassified as dangerous for theaquatic environment (= 100tonns/year)had to be registered.The last registration deadline isJune 2018 for substances from 1to 100 tones

Registration, Evaluation, Authorisation and Restriction of Chemicals

REACH - costs• Raw materials (incl. Intermediates)

• Substances

– Toxicological tests

– Documentation

– Administrative works

The most important parameter is number of registrants for the substance – many dyes have only 1 registrant.

• 1 - 10 t/y min. 40 000 EUR

• 10 - 100 t/y about 300 000 EUR

REACH regulation, influences on productions of colorants, SVHC substances.

Synthesia can provide for itself, but also for other interested companies, sufficient capacity for testing of chemicals due to 100% ownership of VUOS, a.s.–an accredited R & D institution. One department of VUOS, the Centre for Ecology, Toxicology and Analytics (CETA) approved for ecological, toxicological and analytical testing of chemical substances. This department performs practically all necessary experimental works and co-operates in other (expert, administrative etc.) works connected with the REACH regulation.

• SVHC = Substances of Very High Concern

• A substance may be proposed as an SVHC if it meets one or more of the following criteria:

– it is carcinogenic

– it is mutagenic

– it is toxic for reproduction (CMR)

– it is persistent, bioaccumulative and toxic (PBT, vPvB)

• Actually 168 substances, updating two times per year

• Candidate List is the first step of the authorization procedure

• Last changed on 17.12.2015, next expected on June 2016

• SVHC limit 0,1% = 1000 ppm in final goods

Synthesia fulfills the limit SVHC at all colorants

REACH regulation, influences on productions of colorants, SVHC substances.

Synthesia, a.s. has already registered 140 substances and raw materials according to REACH, mostly for the segment of organic pigments.

"Now we are focusing on organic dyes - a priority for our company to 2018“

• Currently about 800 substances - structures of dyes on the market

• REACH registration about 400-500 substances

in year 2018

• Synthesia will register about 60 substances (=

120 commercial colorants/dyes, costs 3.5 – 4.0 millions EUR)

REACH regulation, influences on productions of colorants, SVHC substances.

Three basic groups of organic dyes

Synthesia will register about 60 substances /structures of dyes(= 120 commercial colorants/dyes,

powder and liquid forms,numbers of concentrations)

REACH regulation, influences on productions of colorants, SVHC substances.

Direct dyes

Reactive dyes(monochlortriazine)

Acid dyes(1:2 metal complex)

CLP issues, substances mixtures formation, properties combinations eventuating classification.

Classification, Labelling and Packaging of substances and mixturesEU Regulation No. 1272/2008/EC

Signal wordsR- and S- phrases H- and P- statements

New pictograms

CLP introduces into the EU the globally harmonised system for classifying and labelling chemicals. This means that the same system is now used throughout the world.

CLP issues, substances mixtures formation, properties combinations eventuating classification.

Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers

• ETAD's mission for a sustainable growth in a colourful world • Industry cooperation to "minimize impact on health or environment“ • Representation and advocacy of members• Promotion of product stewardship • Harmonization of health and environmental regulations

• Synthesia membership - more than 10 years• Active in Dyes OC, Pigments OC, Regulatory Affairs C.• Analytical methods, cooperation with authorities, EU commission for toys,

food contact, EN/ ISO norms …• Code of Ethics – keeping of standards, limits, principles …

ETAD – code and principles, cooperation in chains to users and retailer

Communication with ETAD, explaining technical possibilities to produce and limits of used methods

ZDHC and MRSL issues

The Zero Discharge of Hazardous Chemicals ZDHC group developed and published a MRSL www.roadmaptozero.com

Zero Discharge of Hazardous Chemicals

The MRSL restricts hazardous substances potentially used and dischargedinto the environment during manufacturing, not just those substances thatcould be present in finished products

ZDHCmembers

Manufacturing Restricted Substances List

ZDHC substances & limits

ZDHC and MRSL issues

ZDHC and MRSL issues

ZDHC and MRSL issues

AZO dyes are the name of the group of synthetic dyestuffs based on nitrogenthat are often used in textile industry. Some AZO dye stuffs may separate undercertain conditions to produce carcinogenic and allergenic aromatic amines.

The EU AZO Colorants Directive 2002/61/EC sets out that Azo dyes which mayrelease one or more of the 22 aromatic amines (see next slide) in detectableconcentrations, above 30 ppm in the finished articles or in the dyedcomponents may not be used in textile and leather articles which may comeinto direct and prolonged contact with the human skin or oral cavity. Thedirective came into force in September 2003.

Since Annex XVII of REACH came into force in 2009, the AZO Directive2002/61/EC has been replaced by REACH regulation.

Latest development in global sales and producers network in-groups (Inditex, OekoTex, GOTS etc.)

„Banned“ amines

• DIRECTIVE 2002/61/EC - AZO Colorants Directive (REACH Annex 17)

22 amines

• Inditex, OekoTex , ZDHC

- one of the world´s largest fashion groups

- the international testing and certification

system for textiles

22 + 2 amines

• GOTS 4.0- the world´s leading processing standard

for textiles made from organic fibres

22 + 2 + 3 amines

• Next step?

22 + 2 + 3 + ?? amines

4-Aminobiphenyl 3,3’-Dimethylbenzidine

Benzidine 4’-Methylenedi-o-toluidine

4-Chloro-o-toluidine p-Cresidine

2-Naphthylamine 4,4’-Methylene-bis-(2-chloro-aniline)

o-Amino-azotoluene 4,4’-Oxydianiline

5-Nitro-o-toluidine 4,4’-Thiodianiline

4-Chloroaniline o-Toluidine

4-Methoxy-m-

phenylenediamine 4-Methyl-m-phenylenediamine

4,4’-Methylenedianiline 2,4,5-Trimethylaniline

3,3’-Dichlorobenzidine 2-Methoxyaniline

3,3’-Dimethoxybenzidine 4-Amino-azobenzene

– 2,4-xylidine &

2,6-xylidine

– aniline & N,N-

dimethylaniline & p-

phenylendiamine

Latest development in global sales and producers network in-groups (Inditex, OekoTex, GOTS etc.)

The number of banned substances

increases and the limits decline

The tendency regarding the integration of bothall legislation and end-users requirements will be important priority in near future.

Important

• The first step with starting new product (dye, colorant, aditive, final goods = complicatedmixture/chemical coctail) is to evaluatecompliance with legislation, asking certificateconditions etc.

• Consult it with legislative dept. of yourpotencial customers and learn aboutapplication

Conclusion:

Synthesia, a.s. as one of the last producers of organic dyes fortextile, leather and paper industry in Europe intends toproduce and offer stabilized and defined portfolio of organicdyestuffs in highest quality according to both EU legislationand end-users requirements for the future.

Synthesia will register about 60 substances structuresof dyes = 120 commercial colorants:

• Direct dyes• Monochlortriazine Reactive dyes• Acid 1:2 metal complex dyes

+ selected Acid non-metal complex dyes

powder and liquid formsnumbers of concentrations

who is responsible for technical legislation of organic pigments and dyes in Synthesia, a.s

Thank you for your attention

For further informationconcerning REACH

contact

[email protected]