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Chemical Services



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Chemical Services
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The regulation 2014/40/EU (TPD) sets the rules for the manufacture, import and sale of e-cigarettes. It came into effect on 20th May 2016; each Member State is harmonizing its national legislation. A number of restrictions are set such as a limit on nicotine concentration (≤20 mg/ml) and tank volume (≤2 ml). Also, under the new rules a pre-market notification is required. The information to be submitted includes administrative, quality and safety data that require emissions testing by an analytical laboratory and a toxicological assessment.

The new regulations will have a significant impact on business, bringing new costs and major changes in operations. E-cigarette producers should initiate their steps now to avoid lost time and costs.

How can SUSTCHEM help you?

We offer a full range of services to help companies be prepared:

  • Dossier preparations and notifications per type of product including the apparatuses supported by emission testing*.
  • We ensure that minimum emissions testing requirement are met, at a cost effective way.
  • In the absence of guidance and official standards SUSCHEM helps manufacturers to prepare early by preparing their needs based on a deep knowledge of the chemicals and other legislations.

Contact us now! We help you to estimate the cost of compliance and make up your decision.

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SUSTCHEM Engineering provides high-quality and cost effective Pharmacovigilance services and solutions.
We support our clients in a flexible way to help them meet their obligations for drug safety.
We offer a broad range of services such as:

  • Development and Management of Pharmacovigilance Systems
  • Periodic Safety Updated Reports (PSURs) Writing
  • Individual Case Safety Reports (ICSRs) Handling
  • EudraVigilance Medical Product Dictionary (EVMPD) Update
  • Risk Management System
  • Inspections Preparation
  • Audit Preparation & Conduct of Audits
  • Safety Management in Investigator Initiated Studies/Trials
  • Literature Search for Greece & Cyprus
  • Consultancy Services
  • SOP Development and Review
Reach and International Legislation
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REACH is the Regulation on Registration, Evaluation, Authorization and Evaluation of Chemicals. It entered into force on June 1st of 2007. It streamlines and improves the former legislative framework on chemicals of the European Union (EU).

REACH aims to enhance the protection of human health and environment from the risks that can be posed by chemicals, the promotion of alternative test methods, the free circulation of substances on the internal market and raising competitiveness and innovation.

CLP (classification, labeling and packaging)
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The GHS (Global Harmonized System of Classification and Labeling of Chemicals) targets on classifying chemicals according to types of hazards in order to ensure a high-level protection of human health and environment during transport, handling and use of the chemical substances. This is achieved by the use of standard symbols and phrases on the packaging labels and by Safety Data Sheets (SDS).

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A Material Safety Data Sheet (MSDS) is designed to provide both workers and emergency personnel with the proper procedures for handling or working safely with a particular substance. MSDS include information such as physical data (melting point, boiling point, flash point etc.), toxicity, health effects, first aid, reactivity, storage, disposal, protective equipment, and spill/leak procedures. These are of particular use if a spill or other accident occurs.

Registration/Authorisation of Chemical Products
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SUSTCHEM Engineering is a full-service provider in the area of Regulatory Affairs, Product Safety and Consulting in the following sectors:

  • Agrochemicals
  • Biocides
  • Disinfectants
  • Dangerous Chemicals
  • Cosmetics
  • Detergents
  • Lubricants
  • Fireworks
  • Explosives
  • Pharmaceuticals
Chemical Analysis
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SUSTCHEMEngineering provides chemical analysis for all types of chemical productsthrough cooperation with GLP Certified Laboratories, Universities, ResearchInstitute Centers etc.

Reach only Representative
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Compliance with the REACH Regulation (Registration, Evaluation and Authorization of Chemical Substances – EC1907/2006) is mandatory for continued sales of chemicals and products in the European Union. Our REACH Only Representative services allow companies located outside the European Union to deal with REACH pre-registration and registration of substances.

Reach Registration
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SUSTCHEM Engineering assisted many companies in fulfilling their REACH obligations for the 2010 deadline. We submitted more than 30% registration dossiers of Greece, provided CLP compliance services for several EU and non-EU based companies and were actively involved in approximately more than 1,000 SIEFs.

Reach Audit
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In order for a product to be REACH compliant, its constituent components must be in compliance with the Regulation. Where access to the composition is not available for constituent components, supply chains and suppliers must provide evidence and declarations to prove to their customers that they meet the REACH Regulation (Registration, Evaluation and Authorization of Chemical Substances – EC1907/2006) requirements. Since these declarations provide only limited assurance, chain of custody control should be an important part of any REACH compliance strategy. Plus a balanced process of engagement and involvement of the supply chain, supported by auditing and monitoring, needs to be implemented in order o control risk and costs.

Reach Consulting
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Our yearly consulting service provides access to our team of REACH experts who can address your questions regarding your company's specific REACH obligations. This service is applicable for all levels and sizes of business in numerous industries. More specific, with REACH Consulting we provide:

  • Direct access to on-call consulting support
  • Unlimited Q&A about REACH
  • Access to FAQ summaries
  • Education of employees on REACH obligations and requirements
  • Real-time notices on changes to REACH requirements
  • On site meetings to manage your REACH strategy, to ensure your requirements are properly applied and met
  • Building the strategy and detailed report per substance to be exempted from the provisions of REACH Registration
  • Preparing your company to deal with your National Authority REACH inspections