Standards in Chemical
In advanced chemical industries, compliance with quality and safety standards is essential. In this chapter, three key standards GMP, REACH, and MSDS (SDS) along with their related export requirements, are examined. An analytical and practical approach is adopted, drawing on industrial experience and real products (such as choline chloride and silver nitrate).
Good Manufacturing Practice (GMP)
GMP is a set of documented rules and guidelines that ensure manufacturing processes are carried out correctly and that the final product quality is consistent and traceable. This standard is particularly important in the production of pharmaceuticals, food products, and feed additives.
According to GMP principles, the production environment must be clean, equipment must be appropriately designed and segregated, and production records must be carefully maintained. Personnel must also receive relevant technical and safety training. Proper GMP implementation prevents contamination and cross-contamination; when GMP is properly applied, the production environment is clean, personnel are trained, and processes effectively separate different stages of production.
Key GMP elements include:
- Documentation: Preparation and maintenance of complete formulations, Standard Operating Procedures (SOPs), and production records.
- Contamination Control: Segregation of production lines for different products, regular cleaning and disinfection programs, and contamination risk assessments.
- Inspection and Internal Audits: Periodic audits to ensure compliance with GMP requirements and to identify areas for improvement.
- Personnel Training: Continuous training in GMP principles, industrial hygiene, and prevention of operational errors.
- Traceability: Assignment of a Batch Number to each shipment and tracking of raw materials through to the final product.
As an industrial example, Spectrum Chemical states regarding choline chloride production that all handling, packaging, labeling, storage, and testing of choline chloride are conducted at FDA-registered facilities, and all stages are performed in accordance with cGMP under 21 CFR Parts 210 and 211 and ICH Q7 requirements. This ensures production to the highest quality and in compliance with international standards.
Similarly, in the animal feed industry, manufacturers of additives such as choline chloride intending to export to the European Union apply the FAMI-QS standard (Quality Assurance System for Feed Additives) to ensure compliance with EU legal requirements.
For example, glycolic acid, when used as a precursor in pharmaceutical polymers such as PLGA, must be sourced exclusively from GMP-certified suppliers to ensure raw-material uniformity and quality control.
REACH: Registration, Evaluation and Authorization of Chemicals
REACH is the European Union regulation for the registration and evaluation of chemicals, in force since June 2007. Under REACH, any manufacturer or importer placing more than one tonne per year of a chemical substance on the EU market must register it. This requirement applies to substances, mixtures (solutions), and under certain conditions to articles (finished products).
Registration responsibility lies with the EU based manufacturer or importer. Non EU companies typically appoint an Only Representative (OR) in Europe to prepare the registration dossier and submit it via IUCLID to the European Chemicals Agency (ECHA).
The registration dossier includes the following information:
- Substance Identification: Trade names, CAS number, chemical formula.
- GHS Classification and Labeling: Hazard classification in accordance with CLP/EU.
- Physicochemical Properties: Melting/boiling point, density, solubility, etc.
- Toxicological and Safety Tests: Acute and chronic toxicity, respiratory/dermal toxicity, carcinogenicity (CMR) where required.
- Environmental Fate: Biodegradability, aquatic toxicity, bioaccumulation.
- Chemical Safety Report (CSR): For volumes above 10 tonnes/year, a full risk assessment (exposure estimation and risk management) is mandatory.
- Safety Data Sheet (SDS): Prepared according to the GHS format (see MSDS section), providing safety information and emergency measures.
As a hypothetical example, consider a company exporting glyoxylic acid to the EU. To register this substance under REACH, all the above data including toxicological and ecological information must be prepared and submitted via IUCLID to ECHA. After submission, approximately 5% of dossiers are randomly evaluated by ECHA for compliance. Additionally, through the CoRAP prioritization process, substances with high usage and potential risk may be subject to further evaluation or restrictions.
If a substance is placed on the Substances of Very High Concern (SVHC) list, the exporter must obtain a specific Authorization for its use.
MSDS / SDS: Material Safety Data Sheet
The Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS) is a standardized document providing comprehensive information on hazards, properties, and required safety measures. An SDS must accompany every exported chemical shipment so that the recipient can properly handle and store the product.
In countries adopting the Globally Harmonized System (GHS), the SDS follows a standardized 16-section format. Key sections include:
- Identification: Product name, CAS number, manufacturer/importer, contact details.
- Hazard Identification: GHS classification, hazard pictograms, signal words, hazard statements.
- Composition/Information on Ingredients: Components with percentages and CAS numbers.
- First-Aid Measures: Initial measures for skin, eye, or inhalation exposure.
- Fire-Fighting Measures: Suitable extinguishing methods and special precautions.
- Accidental Release Measures: Spill containment and cleanup procedures.
- Handling and Storage: Safe handling and storage conditions.
- Exposure Controls/Personal Protection: Exposure limits and recommended PPE.
- Physical and Chemical Properties: Appearance, odor, boiling point, pH, etc.
- Stability and Reactivity: Reactivity conditions and incompatibilities.
- Toxicological Information: Routes of exposure, symptoms, toxic effects.
- Ecological Information: Environmental impact and biodegradability.
- Disposal Considerations: Disposal methods for substance and contaminated packaging.
- Transport Information: UN number, hazard class, packing group.
- Regulatory Information: Relevant national and international regulations.
- Other Information: SDS issue/revision date and information sources.
Older internal MSDS formats often lacked standard structure. Modern SDSs use the uniform 16 section GHS format worldwide.
For example, the SDS of silver nitrate shows it belongs to oxidizing hazard class 5.1, with UN number UN1493 and Packing Group II; these details are included in Section 14 (Transport Information).
SDS Preparation Checklist for Export
- Complete identification of product and supplier with contact details.
- Accurate disclosure of chemical composition, weight percentages, and CAS numbers.
- Inclusion of all relevant GHS hazard (H) and precautionary (P) statements.
- Clear emergency instructions for first aid and fire-fighting.
- Safe storage and handling guidelines.
- Recommended PPE (gloves, goggles, respirators, etc.).
- Essential physicochemical properties (appearance, flash point, pH, etc.).
- Summary toxicological and ecological assessments.
- Disposal considerations and waste management information.
- Transport details including UN number, hazard class, and packing group.
- Applicable legal references and standards.
- SDS preparation and revision dates.
Standardization Process for Export
To access strict markets such as the European Union or the United States, companies must follow a comprehensive process:
- Technical Documentation: Issuance of a Certificate of Analysis (COA) for each shipment often required by foreign customers showing quality control test results. Along with the COA, an official 16-section SDS, REACH registration documents or compliance certificates (e.g., Only Representative), and final QC test results must be prepared as required.
- Inspections and Audits: Companies must be ready for factory audits by foreign customers or third-party bodies (e.g., REACH or FDA inspectors). Audits assess processes and operational compliance with standards such as GMP, ISO, and environmental regulations.
- Compliant Labeling and Packaging: All labels and packages must comply with CLP/EU and GHS. Hazardous material labels must include substance name, manufacturer address, hazard pictograms, and warning statements. Packaging must meet UN standards for dangerous goods (e.g., UN-approved containers for acids, oxidizers, or gases). For example, silver nitrate must be transported in resistant packaging under hazard class 5.1 (oxidizer) with UN1493 clearly indicated, and in compliance with IATA, IMDG, and ADR transport rules.
- Personnel Training and Change Management: Staff must be trained on destination-market requirements (chemical safety, REACH/CLP, UN packaging). A change management program should also be implemented to control any process or documentation changes in line with updated standards.
By implementing these steps and carefully reviewing each stage, a company can meet the technical and legal requirements of target markets and significantly reduce the risks of inspection failures or shipment rejections.