Regulatory ChemSD

For the control of compliance with regulations and legislation

AT Knowledge & regulatory Services started in 2001 to provide consulting services in the regulatory field, and it developed the ChemSD tool as a complete solution for regulatory management.

Company pillars

Constant contact with regulatory authorities, both national and international.

Experienced consulting team that works to stay at the forefront of regulatory science.

We offer our clients a comprehensive and holistic vision, including technical and regulatory expertise.

Providing high level services on scientific and regulatory affairs

Keeping up and complying with ever-changing national and international health, environmental and safety regulations are challenges many industries face.

Our team of consultants and regulatory experts can help your company develop effective compliance approaches and create internal compliance programs using our scalable software solutions. Our security professionals will help you develop effective compliance strategies to identify and address regulatory compliance gaps.

Geographic Scope

We have an extensive experience with worldwide regulations and we can provide you with regulatory advisory in the following regulatory areas

Software Solutions

We have a powerful suite of software tools to streamline the processes of your Regulatory Affairs Department. This software suite helps your team manage environmental, health and safety (EHS) responsibilities while mitigating the risks of noncompliance. With our tools we can configure a flexible solution that will integrate seamlessly with other systems you may already have (ERP, LIMS,...).

Chem-SD V4 - Functionalities

By seamlessly integrating its functionality with customers existing business processes and systems, Chem-SD V4 improves efficiency while delivering accurate and compliant output. It combines regulatory expertise and industry-leading functionalities to streamline the generation, management and distribution of hazardous materials communication documents.

• Calculation of country specific regulations.
• Generation of multi-language documents (more than 50 languages available). Use flexible formats (Word & PDF) and user defined templates. Includes Exposure Scenarios and SUMI
• Version management and document distribution control.
• Capability to use customer specific names and codes ("multiple re-branding")
• Calculation of complex mixtures with multiple level composition
• Definition of compositional information (impurities, components of natural origin products,...) for each regulation.
• Includes a simulation feature to anticipate the regulatory status of your mixtures at design stage.
• Containing a comprehensive data base of regulatory information for raw materials (more than 2 millions of individual data).
• Easy integration with corporate systems (ERP, LIMS, ...).
• Availability of an automatic Alert system to anticipate out-of-date certificates or other regulatory data.
• A multi-user system with a multilingual user interface that manages multiple levels of data access rights to ensure complete information protection.

Chem-SD V4 - Regulations

The power of Chem-SD derives from the implementation of algorithms to calculate national and international regulations, among which stand out:

Global:

• GHS using the building blocks and specifications of each regulatory area (CLP, HAZCOM, ...)
• Transportation according to IMDG, IATA and regional regulations (ADR, DOT, ANTT, JT/T 617,...)
• Inventory compliance (DSL, TSCA, EINECS, etc.)
• Workplace exposure limits (country specific)

Industry specific:

• Cosmetics Regulations
• Flavours Classification (EC 1334/2008, …)
• Animal Feed regulations
• Detergent Labelling
• Fragrance Allergens & Food Allergens
• Restrictions in the use of certain substances (IFRA, customer specifications, etc.)
• Certificates control (Kosher, Halal, etc.)

Country specific regulations:

• KDGA Fire prevention Act (Korea & Japan)
• TRGS 510 Storage of Hazardous Substances in Nonstationary Containers (Germany)
• WGK Water Hazard Class (Germany)
• NFPA 704 Identification of the Hazards of Materials for Emergency Response (Chile, USA, Mexico)

Chem-SD V4 – Industry specific modules

Chem-SD V4 is a flexible tool easily adaptable to user needs. It consists of a core that manages the basic regulations and a set of modules aimed at offering solutions to various industries.

There are specific modules for the following industries:

CSDCronos

This tool is a job scheduler that can be used to schedule jobs to run periodically at fixed times, dates, or intervals. It also includes the ability to activate alerts (definable by users).

Virtually any operation supported in Chem-SD can be converted to a Scheduled Task. The tasks are grouped into three large classes:

• Direct tasks. Used for tasks that typically automate system maintenance or administration, like importing files, activating interfaces or DB maintenance.
• Tasks that are executed on Work Lists. These are the operations that can be performed on specific elements of Chem-SD, such as, for example, generating a document or exporting legislative data. Tasks of this class always operate on a Work List that contains the elements to be processed.
• Triggered Tasks. The task is executed when a certain event occurs (modification, deletion, creation,...) on a Chem-SD element such as substances, mixtures, documents, etc.

CSDNotif

Many countries or regulatory areas require that products placed on the market be notified to authorities and/or Poison Centers. The process of preparing the content of the notification dossiers is usually a complex process that requires a lot of time from the Regulatory department staff.

A particularly cumbersome case is the obligation established by Article 45 of the EU CLP Regulation, mandating entities placing certain hazardous mixtures on the market to provide information to national appointed bodies.

The CSDNotif module automatically generates, from the data contained in Chem-SD, the notification dossiers to the national authorities in its various variants (initial notification, modifications, ...) complying with the linguistic requirements of each country.

Using the CSDNotif module, your Regulatory Department will simplify product notifications, reduce workload and avoid inconsistencies with SDS.

IUCLIDExtract

Many times, a large amount of data is available in IUCLID format. Typical examples are REACH registrations, Biocides registrations, etc. The information contained in the IUCLID Dossiers can be of various types such as:

• Toxicological information
• Physical and chemical properties
• Environmental information
• Ecotoxicological data
• GHS classification

The problem is that, in general, the information contained in IUCLID is very verbose, making it difficult to extract relevant data. This is where the IUCLIDExtract tool brings value. The user must simply indicate the substances for which he wants to obtain information and indicate the properties, end points or data he wishes to extract.

The tool is capable of decompressing ECHA Dossiers and searching for relevant files according to the user's selection. For each selected IUCLID file, the software analyzes its content and extracts the relevant data for regulatory purposes. If the Dossier contains several files associated with the same data, the tool is capable of determining which is the most relevant data (or data) to be extracted. The processed information can be obtained in a format directly readable by Chem-SD or in the format chosen by the user.