NEED HELP COMPLYING WITH TURKISH CHEMICALS INVENTORY & CONTROL LEGISLATION?
If you produce or import chemicals in Turkey you must comply with the Turkish Ministry of Environment and Forestry (MoEF) By-Law on Inventory and Control of Chemicals.
(Published end 2008, amended Nov 2009 extending compliance deadline to 30 June 2010)
Two amendments have been granted:
1. An extension of the compliance deadline to 30 March 2011
2. To establish a "legal trustee" in Turkey to file registrations on importer\'s behalf.
To comply:
1. Take inventory, differentiate volume and MoEF priority list
2. Gather, compile data and determine "gaps"
3. Data entry into MoEF database
4. Compliance maintenance through updating information
Legal requirements for contact materials
Prof. Roberto Massini
Contents:
• European legislation
• Supplementary Italian legislation
• US Federal legislation
• Conclusions
M. stefaniuk, 2008 antitrust law developments in polandMichal
Antitrust law, similarly to other disciplines of administrative law, concerns
three interrelated aspects of legal regulation: substantive law, procedural law and
legal provisions regulating the status of relevant bodies of public administration.
In 2008, the Polish antitrust field was subject to legal amendments relating
to the status of public administration bodies responsible for competition and
consumer protection governed by the Act of 16 February 2007 on Competition
and Consumer Protection and other specific legal acts.
This presentation was made by me for my college presentations.
Do give due credit and comment if you like it or dislike it.
I upload on topics of indian contract act, economics, constitution of India etc.
Enhancing Chemical Management Within the Framework of Existing TSCA Regulations3ECompany
This presentation provides a brief history of TSCA, as well as an overview of its scope and sections. It also reviews current activity surrounding TSCA reform and modernization and the potential impact that any reform will have on business.
Legal requirements for contact materials
Prof. Roberto Massini
Contents:
• European legislation
• Supplementary Italian legislation
• US Federal legislation
• Conclusions
M. stefaniuk, 2008 antitrust law developments in polandMichal
Antitrust law, similarly to other disciplines of administrative law, concerns
three interrelated aspects of legal regulation: substantive law, procedural law and
legal provisions regulating the status of relevant bodies of public administration.
In 2008, the Polish antitrust field was subject to legal amendments relating
to the status of public administration bodies responsible for competition and
consumer protection governed by the Act of 16 February 2007 on Competition
and Consumer Protection and other specific legal acts.
This presentation was made by me for my college presentations.
Do give due credit and comment if you like it or dislike it.
I upload on topics of indian contract act, economics, constitution of India etc.
Enhancing Chemical Management Within the Framework of Existing TSCA Regulations3ECompany
This presentation provides a brief history of TSCA, as well as an overview of its scope and sections. It also reviews current activity surrounding TSCA reform and modernization and the potential impact that any reform will have on business.
Opportunities for mitigating provisions with likely negative public health impact while remaining compliant, presented by Mohammed El Said University of Central Lancashire (UCLAN) UK. The presentation covers:
- The EU-Ukraine DCFTA
- The IP CHAPTER
- TRIPS-Plus obligations with impact on access to medicines and public health
- Mitigating the negative impact of TRIPS-Plus obligations
The Hazardous Wastes (Management, Handling and Transboundary Movement) Rules (HW Rules) which are currently in force were notified under the Environment Protection Act 1986 by the Ministry of Environment, Forest and Climate Change (MoEF) in September 2008. The HW Rules classify the wastes generated from the various industrial and other sources through Schedule- I and Schedule- II specified there-in. The Rules further categorize the wastes in terms of the permissibility & requirements for their import/export (Schedule-III), recycling (Schedule – IV) and prohibition from import/export (Schedule-VI). The Government has now further considered it necessary in the public interest to address the sustainable development concerns and amend the HW Rules 2008 to enable, (i) the recovery and/or reuse of useful materials from hazardous and other waste materials, (ii) reduction in the hazardous and other wastes destined for final disposal and (iii) ensuring of the environmentally sound management of all hazardous and other waste materials. The Draft of the proposed HW Rules was published by the Government on July 24, 2015 giving a period of sixty days for filing the objections or suggestions. The finalization and notification of these Rules is still awaited. The presentation covers a review of the present & the proposed HW Rules with special reference to the implications of the proposed amendments on the lead recycling industry in India.
K-REACH - How to Prepare for the K-REACH LegislationCovance
In 2015, South Korea introduced legislation designed to protect human health and the environment from the impact of chemicals. The two pieces of legislation introduced were the: Act on the Registration and Evaluation of Chemicals (K-REACH), which mandates the registration of all new and existing chemicals marketed or imported into South Korea at ≥1 metric ton per year, requiring detailed information on their likely hazard to human health and the environment and the Chemicals Control Act (CCA), which focuses on chemical reporting and chemical accident prevention.
Nanotechnology is an innovative area of science that includes the design, characterization, production, and application of materials, devices and systems by controlling shape and size at the nanometer scale (1–100 nm). Nanotechnology incorporation in cosmetic formulation is considered as the hottest and emerging technology available. Cosmetic manufacturers use nanoscale size ingredients to provide better UV protection, deeper skin penetration, long-lasting effects, increased color, finish quality, and many more. Micellar nanoparticles is one of the latest field applied in cosmetic products that becoming trending and widely commercialized in local and international markets.
Comunicação relativa à implementando direitos adicionais a produtos provenientes dos EUA, em sequência da publicação, a 9 de novembro, no JOUE L 373 (em anexo) o Regulamento 1646/2020, de 7 de novembro, que suspende as concessões comerciais da UE para certos produtos importados dos EUA (listados nos anexos I e II do referido Regulamento).
O Regulamento publicado é a reação da União Europeia para obter um reequilíbrio comercial nas trocas com os EUA, face à imposição por este país de direitos adicionais sobre importações de determinados produtos originários da União, culminando um longo processo de discussões entre as duas partes no que diz respeito às ajudas à indústria aeronáutica.
Os EUA queixam-se dos subsídios concedidos pelos Estados-Membros da UE à Airbus e a UE responde com as suas próprias queixas relativamente a ajudas recebidas pela Boeing por via de benefícios fiscais e outros apoios pelos EUA.
1. New Turkish Chemical Regulations Presenter Mr. Selcuk Bilgin Chemical Engineer & Managing Partner of Doruk Sistem www.doruksistem.com.tr
2. BACKGROUND As part of its quest to become a full member of theEuropean Union, Turkey must successfully demonstrateacceptance of the rights and obligations arisingunder the EU system and its institutional governanceframework. Turkey has been an associate EU member since 1963and submitted its application for full membership in1987. Formal ‘‘accession’’ negotiations were openedwith Turkey in October 2005. Among the many components of the ‘‘acquis’’ of theUnion—the European Union’s rights, obligations, andinstitutional framework—are chapters onenvironment,consumer and health protection, and related topics withwhich Turkeymust be aligned to satisfy as a prerequisiteof accession. Adoption of the Regulation is one ofmany measures Turkey is required to take to secure EUmembership.
3. SITUATION Turkey has recently introduced legislation that requires importers and manufacturers of chemical substances to notify them to the Turkish authorities. If you place on the market with substances or mixtures/ preparations/ formulations in Turkey, these requirements may well affect you. You will need to understand the regulatory requirements and, if appropriate, make a notification in Turkish using the IT tools made available by the Turkish Authorities.
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5. To be in compliance with global modal regulations such as GHS,UN ADR etc.& EU Regulations in order to maintain its economicgrowth and position.
13. It was amended on November 10th, 2009 to extend the submission deadline to June 30th 2010 and added polymers to the list of exemptions.
14. It was amended again on May 23rd, 2010 to extend the submission deadline to March 31st, 2011.
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16. Regulation on Inventory and Control of Chemicals Regulation 26/12/2008-(27092) Scope of the regulation (1) This Regulation shall apply to: a) Data collection, submission and accessibility on substances. b) Principles of Control of potential risks of substances on human health and environment. (2) This Regulation shall NOT apply to: a) The substances in transit which are subject to customs supervision, provided that they do not undergo any treatment or processing. b) The substances manufactured or imported for use in military purposes. c) Substances that are < 1mta/year «All other types of chemical substances are under the scope of the regulation»
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20. Regulation on Inventory and Control of Chemicals Regulation 26/12/2008-(27092) CALCULATION Principles Example 1 forthesubstances (<1000tons/yr) Example 2 forthesubstances (≥1000tons/yr)
21. Regulation on Inventory and Control of Chemicals 26/12/2008-(27092) (3) Information required for substances which are manufactured or imported one thousand tons or more (>1000 tons/year) per year in its own or in a preparation are:
22. Regulation on Inventory and Control of Chemicals 26/12/2008-(27092) (4) Manufacturers and importers make all reasonable efforts to obtain existing data regarding sub clauses (d) to (h) and submit this data to the Ministry. Manufacturers and importers are not obliged to carry out further tests on animals for data or information that do not exist. (5) Ministry will publish a list including substances produced on its own or imported on its own or in a preparation, thousand tons or more per year.
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25. Regulation on Inventory and Control of Chemicals 26/12/2008-(27092) (3) Information required for substances which are manufactured or imported in its own or in a preparation, in quantities of one ton or more but less one than thousand tons per year is:
26. Regulation on Inventory and Control of Chemicals 26/12/2008-(27092) (4) The Ministry may require additional information regarding toxicological and ecotoxicological properties within in the framework of Annex-II concerning the risk assessment of substances from manufacturers or importers which provide data in accordance with the first and second paragraphs.
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29. Regulation on Inventory and Control of Chemicals 26/12/2008-(27092) Procedures for the data reporting ARTICLE 10- (1) In case of the substance being manufactured or imported by more than one manufacturer or importer, information in subparagraphs (d) to (h) of the paragraph 3 of Article 7,and the information requested by paragraph 4 of Article 8, may be submitted by a manufacturer or importer on behalf of them, in case of mutual agreement. However, other manufacturers or importers shall provide the information specified from 1.1 to 1.19 in Annex-II and shall make reference to the manufacturer or importer who applies on behalf of them. (2) Manufacturers or importers shall use the special program package in the website of Ministry in order to provide the information specified in paragraphs (3) of Article 7 and 8. (3) In case of import of substances on their own or in a preparation, the natural or legal persons from whom those substances are imported, may fulfill the obligations of importers under the scope of this regulation, through a representative that are established in Turkey and appointed with an agreement. (Only Representative)
30. Regulation on Inventory and Control of Chemicals 26/12/2008-(27092) Updating the given information ARTICLE 11- (1) The manufacturers and importers who provides information in accordance with Article 7 and 8 shall report the relevant changes to ministry within a month, if: A new category of use arises, which changes the type, form, magnitude or duration of exposure of human and the environment to the substance, New data is obtained related to risk assessment, on physicochemical, toxicological or ecotoxicological properties of the substance; A provisional change occurs in the classification of the substance in accordance with the Regulation on Classification, Packaging and Labelling of Dangerous Substance and Preparations; New information is obtained where may be concluded that the substance may pose a serious risk to human health and to the environment; (2) The manufacturer or importer additionally shall submit the information on quantities which is provided in accordance with Article 7 and 8 to the Ministry, every three years, in case of any change in quantities specified in Annexes II and III. (3)In case of changes in terms of address or title of the manufacturer or importer, the manufacturer or importer should communicate the changes to the Ministry not later than a month.
31. Regulation on Inventory and Control of Chemicals 26/12/2008-(27092) ARTICLE 12- (1) If the manufacturer or importer considers that there is a confidentiality problem or has a thought that the disclosure of information provided in Articles 7,8 and 11 might industrially or commercially harm himself, he shall be able to demand the Ministry in written, not to disclose such information to the third parties. If the manufacturer or the importer disclose the information, which was previously deemed as confidential, they shall notify this to Ministry. (2) Industrial and Commercial Confidentiality shall NOT apply to: The name of the substance Data on physicochemical properties and movement and behavior of the substances among environmental media. The summary of toxicological and ecotoxicological tests and in particular the data on carcinogenic, mutagenic effects and/or toxic effect for reproduction ) ç) Information on substance determination and emergency intervention methods and measures that must be taken. Information on experiments performed on animals or to prevent unnecessary repetition of such experiments. In case of release of dangerous substances to the environmental media, analytic methods to enable determination of direct exposure of people to those substances, in addition to the determination of such dangerous substances, (3) Ministry shall inform the applicant about the decision, within fifteen (15) days after the confidentiality application, in accordance with paragraph 1, is received. (4) Acceptance of confidentiality application shall be subject to written approval of Ministry.
32. Regulation on Inventory and Control of Chemicals 26/12/2008-(27092) Priority List ARTICLE 13- (1) Ministry shall prepare and publish a priority list of the prioritized substances or the groups of substances which require to pay attention due to their potential hazards posed to human health and the environment, depending on the information provided by manufacturers and importers in accordance with Article 7 and 8. (2) The following factors shall be taken into consideration for the preparation of priority list: Effects of the substance on human health and the environment Human and environmental exposure to the substance Inadequacy of data on effects of the substance on human health and environment Studies carried out at international organizations and under the international conventions, which Turkey stands as a party. Other national legislation on dangerous substances. (3) If the substance has a chronic effect in particular it is carcinogenic, toxic for reproduction and/or mutagenic or it is well known for aggravating these effects or it causes such suspicion, those substances shall be paid special attention.
33. Regulation on Inventory and Control of Chemicals 26/12/2008-(27092) FOURTH SECTION Assessment of Risks Posed by the Substances to Human Health and the Environment Risk Assessments for the substances appearing on the Priority List ARTICLE 14- (1) Ministry shall perform a risk assessment for the substances in priority list specified in paragraph 1 of Article 13. Depending on this primary risk assessment, the manufacturer or the importer who provided the information on the substance in accordance with Articles 7 and 8, with regard to written request within the scope of the procedure to be specified by Ministry, shall submit the requested information, up on request the additional test results within the period specified by Ministry, after the publication of the list
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35. Supplying information on ingredients is hard as most exporterswith righteous causes keep it as CONFIDENTIAL BUSINESS INFORMATION-CBI.
43. Substances and preparations which are not classified as hazardous butwhich may create hazard to human health and to the environment withinthe specified concentrations,
46. Authoring and Distribution of Safety Data Sheets for Hazardous Substances and Preparations Regulation (27092) Out of Scope (Continue) Animal feed Transport of dangerous goods by railways, motorways, seaways,inland waterways and airways, Substances and mixtures which are subject to customs supervision,provided that they do not undergo any treatment or processing, andwhich are in temporary storage, or in a free zone or free warehousewith a view to re-exportation, or in transit Explosives, military supplies and products placed on the marketsthat has a pyrotechnic effect about which there are data providingand protective provisions covered by other regulations,
51. R and S phrases should be as they are on Annex V&VI of ClassificationReg.
52. Section order is same with Annex II of REACH except: the inversion of Section 2 & 32.Composition/information on ingredients, 3.Hazards identification, (MoEF is planning an amendment on that inversion & order of sections under REACH Annex II is considered to be compatible )
66. We assist chemical manufacturers, pesticide registrants, grower/commodity groups, and trade associations in dealing with issues that affect their ability to do business effectively.
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68. OUR Specialities Doruk Sistem’sCenter for Chemical Regulation and Occupational Safety specializes in timely, high-quality, creative, and practical solutions to problems that affect our clients' ability to conduct business local and globally. Our experienced staff includes both technical and regulatory consultants who are experienced in dealing with with pesticide and non-pesticide products, including conventional chemicals, biochemicals, agrichemicals, microbials, antimicrobials, consumer products, detergentproducts, dyes, cosmeticsand products of biotechnology. We draw upon expertise in a variety of backgrounds, including epidemiology, biostatistics, toxicology, ecotoxicology, environmental sciences, and risk modeling, to best meet our clients’ needs. Our international team and partnersof regulatory and scientific experts offers additional support for agrichemicals and biocides regulated under Turkey, EU and US directives. Whatever your needs, Doruk Sistem can augment your regulatory team and provide flexible, strategic consulting.
