The services that SustChem Engineering offers, include:
The REACH Regulation (1907/2006/EC) concerns documentation, licensing and limitations of chemical products.
SustChem Engineering offers complete REACH services.
The services that SustChem Engineering offers, include:
- Formation and submission of documentation files at the electronic base of ECHA
- Taking over the role of the “Lead Registrant”
- Conduct of Chemical Safety Reports (CSR)
- Issuance of report scenarios and Safety Data Sheets
For substances that are characterized as substances of very high concern (SVHC) and in order for them to continue to be produced – imported - used (in clean form, mixtures or objects) at the EU, SustChem Engineering bears their disclosure and the composition of licensing folder to the ECHA.
We take the role of the Only Representative of non-European productions/imports of chemical substances.
Conduct of a diagnostic study concerning the involvement level of a company to the REACH regulation and every relevant legislation. We suggest financial and practical compliance means. We undertake the training of the responsible persons within the company, the communication with the Responsible Authorities and the coworkers of the company, by offering at the same time a 24h support base via the Helpdesk operation.
The service is suggested for the onsite audit of the involvement level of a company with the REACH & CLP Regulations and with the provision of compliance advices.
It is specifically designed for businesses that face problems during the import of their products. SustChem Engineering is responsible for the issuance of all the required documents (pro-submission, CLP disclosure, SDS, product label), without the interested party to be burdened with delay cost.
The CLP Regulation (Classification, Labelling, Packaging) is the Regulation no. 1272/2008/EC for the classification, labelling and packaging of chemical substances and mixtures.
SustChem Engineering is responsible for the complete compliance of chemical products that are available in the market to the CLP Regulation. More specifically, we hold the following CLP services:
- Classification and Labelling of chemical products that the company produces, imports or transports
- Conduct of a classification study
- Definition of the role and obligations at the supply chain
- C & L disclosure of chemical substances at ECHA
- Documentation at the National Register of Chemical Products of the General Chemical State Laboratory of Greece
Learn more about the CLP regulation that you are interested in using our CLP Wizard
Authoring of Safety Data Sheets (SDS)
It is necessary that the chemical products that are mostly for the professional users to be accompanied with Safety Data Sheets (SDS), based on the demands of the Regulation (EU) 2015/830 and the Regulation 1272/2008/EC (CLP) in the language of the market where the chemical products are available.
SustChem Engineering has a reliable software for the production of Safety Data Sheets which is updated based on the newest regulation along with the required scientific personnel for the assessment of the result.
The Safety Data Sheets can be composed in Greek, English and in eighteen (18) other languages.
In order to ensure a high safety level of employees, legislation imposes the provision of an updated Safety Data Sheet for every chemical product to the professional users. Due to the constant changes of the legislation, the management of the SDS becomes more and more difficult.
SustChem Engineering offers via a specialized software, for the needs of your company the:
- Storage of the sum of company’s SDS
- Review based on the current legislative demands of the current Safety Data Sheets
- Easy Access and finding of the SDS via smart applications
Release of electronic cigarette
Registration of dangerous chemical products to the General Chemical State Laboratory
The chemical products that are classified as dangerous for their physicochemical properties or for the human health must be documented to the National Register of Chemical Products of the General Chemical State, according to article 45 of the CLP Regulation. Responsible for the documentation are the producers, importers and disposers of the products in the Greek market.
Following the successful documentation of products, the identification number / product is given. For products that haven’t been documented in the National Register of Chemical Products, a fine is imposed.
SustChem Engineering is responsible for the submission of the sum of products that need to be submitted to the National Register of Chemical Products.
Release of Air Fresheners
Air fresheners are considered chemical products (mixtures). Therefore, they need to be accompanied by a Safety Data Sheet, to be classified according to the CLP Regulation and to be documented to National Register of Chemical Products, provided that they have been classified as dangerous.
Moreover, for air fresheners, specific classification demands are applied according to National Legislation.
Producers of air fresheners in Greece need to have a license for the production of air fresheners, provided by the NOM.
For information regarding the license of air fresheners, click here
Fertilizers, depending on their composition, are divided into two basic categories, the EC fertilizers that fall under the 2003/2003 Regulation and the New Type fertilizers that fall under the National Legislation.
The New Type fertilizers are licensed by the Ministry of Rural Development and Food following the submission of a technical folder and its authorisation by the Technical Advisory Committee on Fertilizers.
SustChem Engineering offers the following services:
- Gathering and assessment of the required data
- Communication with Suppliers, once it is required
- Composition of the technical folder
- Submission of the folder and monitoring until the final licensing of the product
Legalization of Detergent/Cleansing Product
Detergents and cleansing products that are available in European and Greek markets need to comply with the 648/2004/EC Regulation. This Regulation imposes obligations that concern, amongst others, the following:
- The direct biodegradability of the content of surfactants
- The special classification requirements
- The disclosure to the Poison Center
For cleansing products an additional national legislation applies.
The producers of detergents in Greece must have a special license for the operation of a detergent production factory. For information regarding the issuance of the license, press here .
SustChem Engineering is responsible for the conduct of all the required procedures for the legal release of cleansing products to the local and European market.
National authorisation of biocidal products, that fall under NOM
Biocidal products, PT (Product Type) 1, 2, 3, 4, 5, 6, 7, 11, 20 & 22 are approved by the National Organization for Medicines.
The biocide folder requires information concerning the physicochemical, toxicological and ecotoxicological data of the same product, but also the content of the active ingredient. If the efficacy tests are not available for the biocide, they must be executed to the responsible laboratory.
Our company is cooperating with laboratories and therefore we can bear the completion of the folder even in this case.
For the authorisation of a new biocidal product, an administrative fee of 2.000,00 euros + 2,4%. is required.
National authorisation of biocidal products, that fall under the Ministry of Rural Development and Food
Biocidal products, PT (Product Type) 8, 9, 10, 12, 13, 15, 16, 17, 19, 21 & 23 are approved by the Ministry of Rural Development and Food, according to the 132428/2009 JMD with a simplified procedure, since efficacy tests are not required.
An administrative fee of 200,00 euros is required.
National authorisation of rodenticides (PT:14) & insecticides (PT:18), that fall under the Ministry of Rural Development and Food
Rodenticides (PT: 14) and insecticides (PT: 18) are approved according to the 4829/52048/2012 JMD by the Ministry of Rural Development and Food. The complexity of the folder depends on the combination and concentrations of the active ingredients that are included in the product. If a relevant product is available in the Greek market, the required supporting documents are fewer and the administrative fee is lower, compared to other cases.
Approval of biocidal products, BPR
The European Regulation for biocides, 528/2012 is in force since 1.9.2013. All biocides need a license according to the BPR, before being available on the market, provided that the included active ingredients have already been approved.
SustChem Engineering is responsible for the folder preparation:
- The National Authorization
- The Mutual Recognition
- The Union Authorization
- The Simplified authorization
- The Documentation to the catalog of the active ingredients suppliers (Art. 95)
Moreover, is responsible for the monitoring of Task Force active ingredients, and also for the general consultative support concerning matters of the BPR.
Preparation of cosmetics folder– CPNP disclosure
According to the (EC) 1223/2009, producers and importers of cosmetics are obliged to prepare a folder (PIF) and disclose their products to the CPNP. Our company offers cosmetics services, while is cooperating with laboratories that conduct tests in cosmetics (e.g. challenge test, patch test).
For ISO 22716 certification: Good Manufacturing Practices at Cosmetics Companies, press here
Classification of dangerous goods (ADR/IMDG/IATA) based on UN
SustChem Engineering besides of ADR Consulting (Consultant of Safe Transport of Dangerous Goods) also undertakes the classification of products based on UN, based on their chemical composition and riskiness.
Disclosure of standard foods, special foods for athletes & dietary supplements to the NOM
SustChem Engineering is responsible for the disclosure of standard foods, special foods for athletes and dietary supplements to the National Organization for Medicines via the electronic gate of its services.
Licensing of Oil Dispersants
Chemical oil dispersants, are the liquid chemical substances that are used for breaking down the oil into smaller droplets that reduce the surface tension of the water oil system.
The chemical oil dispersants of 3rd generation are allowed according to the terms of the Decision No. 5219/F. 11/4/2000
In order for the chemical oil dispersants of 3rd generation to become available in the Greek market, an authorisation must be given by the General Chemical State Laboratory following the submission of the relevant request.
SustChem Engineering is responsible for the composition and submission procedure of the authorisation folder of the chemical oil dispersants of 3rd generation to the General Chemical State Laboratory.
Approval of plant protection products, that fall under the Ministry of Rural Development and Food
SustChem Engineering is responsible for the preparation of the plant protection products folders, according to the (EC) 1107/2009 for the following cases:
- National Authorization
- Mutual Recognition
- Zonal Authorization
- Update or Modification
Provided that the Assessment Report (dRR) is not available, our company cooperates with laboratories of Greece and abroad, in order to cover the wide range of the subject.
Disclosure of lubricants/ valvolines release
Producers of lubricants & valvolines in Greece as well as the importers of lubricants & valvolines must disclose them to the Directorate of Petrochemicals of the General Chemical State Laboratory with the submission of a folder.
Disclosure of Medical Devices
Medical devices are divided into 4 categories based on the level of invasion to the human organism. The following products are included: orthopedic, examination gloves, contact lenses, gauzes, wheelchairs etc.
They must bear the sign of the CE, according to the 93/42/EC Directive.
SustChem Engineering is responsible for the complete compliance of medical devices with the legislation in place.
- Classification of the medical device to the proper category
- Preparation of the technical folder for the submission to the NOM
- Certification of product based on the CE
- Registration to Manufacturers’ Registry of NOM
- Issuance of license for the production of medical devices
The above procedures require administration fees that range between 200,00-500,00 euros , depending on the number of medical devices.
Exemption STS issues for industrial products (Solvents, Alcohol, Electronic Cigarettes)
SustChem Engineering offers technical support for the implementation of the legislation of special Fees of Consumption, Precursors STS exemption procedures for industrial activities.