Regulatory FAQ
This is an FAQ of commonly asked questions about Albert Regulatory. Please feel free to reach out to our support team if there are any questions you may have that are not present in this list.
Q: How frequently are hazard classifications and regulatory content updated in your system?
Albert has adopted a quarterly refresh timeline for its primary hazard information due to the frequency of regulatory list updates, including ECHA, Japan NITE, SafeWork Australia, etc.
Q: What is the typical lag time between when a regulatory change is effective and when it becomes available in your system?
The lag time depends on the type of regulatory change being requested. For small updates, i.e. list changes, expected timeline is 1-2 days post-data validation. For larger updates, i.e. GHS revision adoption, expected timeline is in the order of weeks due to the scope and as Albert ensures ample research, implementation, and validation of the system to comply with the new regulations.
Q: Is there a process in place for making an urgent regulatory update in your system outside the normal update cycle?
Yes; Albert has a ticketing system in place. If there is information that is proprietary to the customer (i.e. TSCA 8(b) confidential listing status) or a classification you disagree with (i.e. proprietary test data), then the customer can submit a ticket with the required information and the Regulatory team will receive the ticket and make the changes for the customer. Albert recommends setting up governance for approvals and requests on updates given the crucial or confidential nature of the information.
Q: Does your system provide alerts or notifications when classifications or regulations change?
Yes; Albert can provide notifications. This would need to be down selected due to the large amount of information that Albert may update at the same time. Albert Regulatory and the customer’s regulatory department would filter CAS or lists that are important and then decide how this information can be presented.
Q: Does your system determine and assign accurate dangerous goods classifications (e.g., UN numbers, packing groups)?
Yes; Albert can automatically assign UN numbers and packing groups for certain dangerous good categories. Due to the level of severity of some classifications (i.e. Explosives, lethal acute tox mixtures, pyrophoric materials, etc.), Albert limits the creation of SDSs and transport classifications for these hazardous substances. This level of hazard should be manually assessed to ensure adequate safety and compliance. More information on how the system selects these classifications can be found in Albert’s Regulatory paper.
Q: Which regulatory bodies or jurisdictions does your system support?
Albert currently supports 25+ countries/regions. The list is Australia, Austria, Brazil, Belgium, Canada, China, Czech Republic, Denmark, England, France, Germany, Greece, India, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Taiwan, and USA. A regulatory list that covers all the sources of information can be provided upon request.
Q: Does your system support the handling of trade secrets and regional rules for substance naming and disclosure?
Yes; Albert has logic to consider what can or cannot be hidden as trade secret for each region's specific regulations. This way, when anyone generates an SDS, the most updated regulations will be followed for trade secrets.
Q: What is the source of your regulatory database? How frequently is this database reviewed and updated?
Albert pulls from sources such as the ones listed above in the second question. This data is refreshed quarterly. If there is a large refresh or change known, Albert will pull new information when needed.
Q: What is the average turnaround time for generating SDSs and corresponding product labels?
One of the perks of using Albert is the instant auto-generation of SDSs and Labels. Using Worksheet, formulators can make their intended formulations and create an SDS within 10 seconds for any supported region. This allows for quick hazard and regulatory review without needing to check with Regulatory/PSRA teams. Albert supports different customization (logos, custom field info, sizes) depending on what is required for each product line. Label generation is also under 10 seconds. Albert’s Regulatory team would set up all the customer’s formats and preferences beforehand to ensure the generation of these labels is consistent between locations.
Q: Once finalized, is the SDS draft saved in the system? Where are they housed? Can it be reopened and edited later if needed? What are the options for distribution? Do you keep historical data?
Once an SDS is created, Albert stores it under the formula inventory item as a PDF. Each iteration of the SDS can be reopened and downloaded as needed. This also houses an Excel overview of every CAS record present in that SDS. This allows for review and comparison later if required. SDS/TDS/Certification Letters (any document) are also stored inside Raw Material inventory items. This allows storage for any document not originating from Albert.
Q: How do you keep up with every changing regulation to keep existing R&D SDSs current with regulatory requirements?
Albert Regulatory keeps a close eye on worldwide regulations. Using notifications from the regulators themselves or other regulatory consulting companies/newsletters, Albert tracks potential and impending changes and plans those updates into its product development schedule. This way when an update is pending, Albert can prepare, develop and implement before it comes into mandatory effect.
Q: Which UN Purple Book is currently being followed for GHS compliance?
Albert uses each country's hazard communication/classification regulations to ensure compliance. As far as a generic template, GHS Rev 8 is the most recent version imported. As new countries adopt the newer regulations, then the decision is made to include them in our ruleset.
Q: Do you apply mandatory classification for certain materials as required by some countries?
Yes ; The best example of this are the Specific Concentration Limits (SCLs) provided and mandated by the European Union. This information is updated regularly and enforced in the rule engine.
Q: How are SDSs created for countries who have not adopted GHS?
Albert and the customer can make a business decision on this depending on the country. As an example, EU SDSs are often used for India compliance.
Q: What out of the box reporting transactions are available, and can users create their own?
Albert supports the creation of reports and offers an entire Reporting module where users can create their own reports. From Prop 65 and Hazardous Air Pollutants to SNURs and storage compatibility.