For each translated Safety Data Sheet, we check the classification and other requirements resulting from the currently applicable legislation of the state concerned, and always adjust it so that it is fully compliant with this legislation.
We will carry out a detailed audit of your duties in the field of chemical legislation and provide you with subsequent service. We will train your employees or take care of your obligations.
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We will create safety data sheets for you in all European languages. At the same time, we will control the correctness of the classification and other duties arising from the chemical legislation - label designs, PCN notification, C&L Notification etc.
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We will define your responsibilities for electronic cigarettes and related products and provide complete notification to the EU-CEG. We will ensure legislative requirements for labeling and create other related documents that must be part of tobacco products.
We provide counseling on legislative requirements regarding detergents placed on the market. We create label and data sheet design for you in compliance with the detergent regulation. We will notify your products to the PCN portal.
We provide complete service for companies placing biocidal products on the market. We review the validity of active substances and approved suppliers. In addition, we can take care of registration of biocidal products.
We provide professional, legislatively compliant assistance in UFI creation and subsequent product notification through the PCN system. We verify whether you are directly concerned with UFI and provide complete assistance from counseling to UFI creation and subsequent product notification.
Not sure if our services are suitable for your
company? Call or write to our specialists and we will discuss all the details regarding possible cooperation with you
info@gracilis.cz
+420 602 661 029
One of the common problems we encounter is imperfect awareness of the full spectrum of responsibilities and obligations that our clients must fulfill. While they comply with the regulations and law, they are aware of, they often do not know of some of the relevant legislation. Usually, it’s only discovered in the process of a control carried out by competent authorities. These companies are unknowingly exposing themselves to the risk of sanctions or remedial measures, in the best case.
We solve everything for you, or we will train your employees so that they can fulfill their obligations independently.
We carry out a detailed analysis and define the legislative obligations of your company (under REACH, CLP, Detergents Regulation and Biocidal Products and Active Substances Regulation). Subsequently, we provide training to show you how to fulfill your legislative obligations.
We check whether you are complying with all obligations when importing chemicals or products from third countries. In these cases, you are subject to the same legislative obligations as producers within the EU.
We check if you comply with the conditions for placing hazardous chemical products on the market under your own name. Then, for example, the obligation to notify in the PCN portal applies to you.
We provide our clients with professional support throughout the entire cooperation. You can write or call us any time.
We monitor all the legislative changes that apply to you, and we notify you of any changes through electronic infomails.
We systematically check the correct setting of the chemical legislation compliance system in your company. We provide this service both internally or externally (by sending documents).
In this step, we conduct a thorough analysis of all your existing practices and and currently processed documents and review whether you comply with applicable legislation. We will then process your Safety Data Sheets in detail.
We offer to our clients two methods for executing the entire process:
You can send us your complete documentation electronically, and we will carry out all acts externally – in our company. Alternatively, subject to prior agreement, we will come to you and internally resolve everything at Your company.
It is up to you which option will best meet your requirements.
At Gracilis we have always placed great emphasis on the personal touch, professionalism and detailed knowledge of the applicable legislation. Thanks to this, we are able to provide a high-quality and comprehensive service for our clients, one in which they can always place their absolute trust.
Our primary aim is to ensure fully functional workflow for making Safety Data Sheets and to provide high-quality and long-term client support. In addition, we also offer an operational service when solving urgent requests in the case of upcoming checks and inspections.
We also participate in the development of SBLCore software, a unique tool for the creation and subsequent management of Safety Data Sheets.
So, feel free to contact us at any time and we will happily help you solve your problem.
“AEROTEC GROUP a.s. began to cooperate with GRACILIS s.r.o. on the creation of Safety Data Sheets (SDS) in 2016. Six basic series of SDS in different language versions have been produced during this cooperation. We would like to highlight their very responsive and personal approach, their speed and efficiency in solving partial tasks and especially the quality of the work done. We have also very much welcomed their consultancy and other services with respect to the statutory obligations of contracting companies in relation to Czech and European legislation. Considering the range of services provided, we also appreciate their reasonable pricing policy. On behalf of our company, I can therefore absolutely recommend GRACILIS s.r.o.”
Radek Chvojka
AEROTEC GROUP a.s.
“Over the course of our long years of co-operation, Gracilis has become an important partner for us. We especially appreciate their professional and responsive approach. If needed, we can always rely on their quick and effective solution to whatever situation may have occurred. We are very satisfied with Gracilis’ services.”
Radovan Netolička
ADI servizio s.r.o.
“We have been cooperating with Gracilis for several years. We especially appreciate getting quick solutions to particular requirements and professional help should any odd situations arise. Communicating with them is characterized by their responsive behaviour and willingness to help. We are satisfied with the services provided. Thank you.”
Martina Němcová, DiS
TECH-LIT CZ s.r.o.
The REACH regulation applies not only to the registration, evaluation, authorization and restriction of chemicals but also to the creation of Safety Data Sheets. The format of Safety Data Sheets is specified in the Commission Regulation (EU) 2020/878. Safety Data Sheets are a basic source of information on chemical substances or mixtures – one could call it a "bible" for chemicals or mixtures.
REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (REACH).
The CLP Regulation deals with classification, labeling and packaging of chemical substances and chemical mixtures, the classification being the basis not only for the labeling and packaging of products (chemical substances and mixtures), but also for creation of Safety Data Sheets. The regulation also includes the List of Harmonised Classification and Labelling for Certain Hazardous Substances, which is part of Annex VI of this Regulation.
REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (CLP).
The Detergent Regulation covers washing and cleaning agents, and defines the specific ingredients (concentration ranges, groups of substances or specific substances using their INCI names), which are subsequently placed on labels and Safety Data Sheets. Ingredient datasheets are either for healthcare professionals or for consumers.
REGULATION (EC) No 648/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on detergents.
The Biocidal Products Regulation covers placing biocidal products and active substances on the market. Labeling of products has its specifics (for instance indication of active substance concentrations in metric units). Each biocidal product may only contain approved active substances or active substances that are in the revision phase. Moreover, they can only be used for the approved biocidal product type.
REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the making available on the market and use of biocidal products.
