RegAffairs AI MCP Server

Answers a regulatory question that needs reasoning across several sources, jurisdictions or industries, or one that no industry tool covers. Examples: "is X restricted and what must my SDS say", "compare EU and GB rules for Y", "who must notify, by when, under which article". The tool runs the RegAffairs AI research agent over more than 1,400 regulator datasets and returns a written answer with numbered citations. Sources include ECHA REACH and CLP lists, EU food, cosmetics, plant protection and biocides law, HSE, US EPA TSCA, FDA 21 CFR, California Prop 65, EudraLex Volume 4 GMP, ICH, EMA and Health Canada. Each citation links to the source document. The tool can take up to a minute. If it is still running, it returns `status: "running"` and an `answer_id` for `regaffairs_get_answer_status`. Each call counts as one question on the user's RegAffairs AI plan and is saved to their history. Not intended for a single fact that an industry tool answers (one substance's list status or classification, an exposure limit, an ingredient's status, an MRL, a drug or device register entry). Not intended for legal advice, clinical trial design or FDA submission strategy.

Checks whether a biocidal active substance is approved and for which product types (PT1 to PT22), whether a supplier is on the Article 95 list, whether a biocidal product or disinfectant is authorised, and which EPA-registered disinfectants work against a pathogen. EU coverage: BPR active substance approvals, the Article 95 supplier list, Union authorised biocidal products, BPC opinions and the product type definitions. National: the GB biocides active substances, GB Article 95 list and GB biocidal products register (HSE), the French SIMMBAD inventory and the ANSES biocide decisions register, and the German BAuA register of notified biocidal products. US: EPA List N and the other selected EPA-registered disinfectant lists by pathogen. Canada: Health Canada's archived COVID-19 lists of hard-surface disinfectants and hand sanitizers. Give an active substance or a product name. Not intended for plant protection products or MRLs (`regaffairs_check_pesticide_approval_and_mrl` covers those).

Checks whether one or more chemical substances (name, CAS or EC number) are registered, listed, restricted or banned, and screens a bill of materials. It resolves the identity against the ECHA C&L Inventory and REACH registered substances, the EU customs inventory (ECICS), the US TSCA Inventory, the Australian AICIS inventory and the Turkish chemical inventory. It then checks the ECHA SVHC Candidate List, REACH Annex XIV (authorisation, with sunset dates), REACH Annex XVII (restrictions, with entry conditions), CoRAP and POPs; the UK REACH candidate, authorisation and restriction lists (HSE) and the UK REACH candidate list policy paper (Defra); Turkey KKDIK Annex 17; US EPA TSCA section 6 risk management rules, SNURs and PFAS reporting; the California Prop 65 list with safe harbor levels; Belgian PFAS restrictions; and the AICIS banned and restricted chemicals list. Accepts up to 50 substances. A substance missing from a list is reported as not listed on it. Not intended for hazard classification, pictograms or UN numbers (`regaffairs_get_ghs_hazard_classification` covers those), exposure limits (`regaffairs_get_workplace_exposure_limits`), or cosmetic, food, pesticide or biocide ingredient status (the matching industry tools cover those).

Checks whether a cosmetic ingredient is banned, restricted or permitted, and gives its INCI name, maximum concentration, product-type conditions and label warnings. It covers the EU Cosmetics Regulation (EC) No 1223/2009 Annexes II to VI with entry numbers, the EU common ingredient names glossary (Decision 2019/701, the last published edition), the UK cosmetics rules and UK ingredient opinions, the SCCS Notes of Guidance, ICCR reports on fragrance allergens and nanomaterials, US prohibited and restricted cosmetic ingredients, 21 CFR Parts 700 to 740, the Health Canada Cosmetic Ingredient Hotlist, the ASEAN Cosmetic Directive annexes and the Japanese cosmetic ingredient labelling names list. Not intended for food, medicines or general chemical restrictions (the food, pharma and chemical tools cover those).

Checks whether a medicine is authorised in a market, with its approval details and shortage status, or a medical device's classification, registration, approval or notified body. Medicines: the FDA Orange Book (approved drugs, therapeutic equivalence, patents and exclusivity), EMA authorised medicines, EMA orphan designations, the EMA, FDA and MHRA shortage lists, the Health Canada Drug Product Database (DIN) and Notice of Compliance database. Devices: the FDA device classification database (product codes, device class, regulation number), FDA De Novo decisions and PMA approvals, FDA MAUDE adverse event reports, MHRA guidance on registering devices for the GB market, EU NANDO notified bodies under the MDR and IVDR, the CDSCO approved device lists (India) and the Italian national medical devices database. Not intended for GMP or ICH guidance (`regaffairs_find_pharma_gmp_and_ich_guidance` covers that), for MDR or IVDR legal requirements, or for clinical trials.

Checks whether a food additive (E-number), colour additive, novel food, vitamin or mineral form, food contact substance or contaminant limit is allowed, and under which conditions, in the EU or US. EU coverage: Regulation (EC) No 1333/2008 Annex II with food categories and maximum levels, the Novel Food Union list (Regulation 2015/2283), contaminant maximum levels (Regulation 2023/915), the food supplements Directive 2002/46/EC and fortified foods Regulation 1925/2006, the plastics food contact Union list (Regulation 10/2011), the German BfR food contact recommendations, and EFSA scientific opinions. US coverage: 21 CFR Parts 170 to 189, FDA GRAS notices, the FDA substances added to food inventory, colour additives in 21 CFR Parts 73 and 74 and the FDA colour additive status list, food contact notifications and indirect additives. Not intended for labelling, allergen or health claim questions (`regaffairs_check_food_label_and_allergens` covers those) or pesticide residues (`regaffairs_check_pesticide_approval_and_mrl`).

Answers what a food label must show (mandatory particulars, nutrition declaration, ingredients list, allergen emphasis, gluten-free, date marking), which allergens must be declared, and whether a nutrition or health claim is authorised. It covers the EU Food Information to Consumers Regulation (EU) No 1169/2011, the EU nutrition and health claims Regulation (EC) No 1924/2006 and its register, the GB health claims register, Regulation (EU) No 609/2013 on food for specific groups, US 21 CFR Parts 100 to 169 (food labeling and standards of identity), the FDA authorised and qualified health claims lists, Food Standards Code Standard 1.2.2 on food identification and the FSANZ register of notified food-health relationships (Australia and New Zealand), and FSSAI labelling amendments (India). Not intended for whether an ingredient or additive is allowed (`regaffairs_check_food_additive_or_ingredient` covers that) or for cosmetic labels (`regaffairs_check_cosmetic_ingredient`).

Checks whether a plant protection active substance is approved, banned or under review, and gives the maximum residue level (MRL) or tolerance for a crop. EU coverage: approvals under Regulation (EC) No 1107/2009, candidates for substitution, emergency authorisations, MRLs under Regulation (EC) No 396/2005, and the EU fertilising products Regulation 2019/1009 for biostimulants. GB: the HSE active substance register and GB MRLs. US: EPA tolerances (40 CFR 180), registration review dockets and the EPA pesticide chemical search. Also Health Canada pesticide product data, the Australia New Zealand MRL schedule, Codex pesticide residue limits, and ANVISA monographs and re-evaluations (Brazil). Not intended for disinfectants and other biocides (`regaffairs_check_biocide_active_substance` covers those) or for industrial chemicals.

Checks whether a substance is restricted in textiles, clothing, footwear or leather and what limit applies under a brand or certification list, and what a textile fibre, care or flammability label must show. Substance lists: the ZDHC MRSL, OEKO-TEX Standard 100 limit values by product class, the bluesign system substances list, REACH Annex XVII entries that apply to textiles and leather (for example entry 72 on CMR substances in clothing), the EU Ecolabel textile criteria, and Japanese household goods limits (formaldehyde). Labelling: the EU textile fibre names Regulation (EU) No 1007/2011, the US Textile Fiber Products Identification Act (16 CFR 303), the FTC care labeling rule (16 CFR 423) and wool and fur rules, the Canadian Textile Labelling Act, and US flammability standards (16 CFR 1610, 1611, 1615, 1616). Give substances or a topic. Not intended for general chemical status outside textiles (`regaffairs_check_chemical_substance` covers that).

Finds what a GMP or ICH guideline requires and the text of a GMP annex or ICH guideline, and checks whether a UK site holds an MHRA manufacturing or wholesale (GMP/GDP) licence. It covers EU GMP (EudraLex Volume 4, Parts I to IV and Annexes 1 to 21), US cGMP for finished pharmaceuticals (21 CFR Parts 210 and 211), the ICH Quality, Safety, Efficacy and Multidisciplinary guidelines and the ICH M4 Common Technical Document, Directive 2001/83/EC, the MHRA GMDP register (GMP and GDP certificates, manufacturer and wholesaler authorisations), MHRA GMP inspection deficiency data, and EDQM OMCL network market surveillance reports. It returns passages with the guideline code, section and version date. Give a topic, a guideline code or a site or company. It does not count as a question. Not intended for whether a medicine is authorised or in shortage (`regaffairs_check_drug_or_device_approval` covers that), for clinical trial conduct or GCP, or for FDA submission strategy.

Fetches the result of a `regaffairs_ask_question` call that returned `status: "running"` and an `answer_id`. It waits up to 40 seconds and returns the finished answer with citations, or `running` again. It does not count as a new question. Not intended for starting a new question.

Looks up a substance's hazard classification, GHS pictograms, H-statements, signal word or label elements (for example for SDS sections 2 and 3 or a CLP label), and its UN number and transport hazard class (SDS section 14). It returns the EU CLP Annex VI harmonised entry (hazard classes and categories, H-statements, pictograms, signal word, specific concentration limits, M-factors and the ATP that set it) from ECHA's harmonised classification list and Regulation (EC) No 1272/2008. Optionally it adds the self-classifications notified to the ECHA C&L Inventory, the GB mandatory classification list and GB CLP (HSE), pending CLH intentions and RAC opinions, the Korean GHS classification list, and the US DOT Hazardous Materials Table (49 CFR 172.101: UN number, proper shipping name, hazard class, packing group). Not intended for mixtures, which need the user's own calculation, for ADR, IMDG or IATA transport rules, or for whether a substance is restricted (`regaffairs_check_chemical_substance` covers that).

Looks up occupational exposure limits for a substance (OEL, WEL, PEL, AGW, VLEP, MAC, STEL) in one or more countries, for example for SDS section 8, a COSHH assessment or an OSHA compliance check. It covers HSE EH40 and the COSHH Regulations 2002 (GB), TRGS 900 and the GESTIS substance database (Germany), INRS VLEP tables (France), INSST LEP (Spain), the SER database (Netherlands), FOD WASO limits (Belgium), the HSA chemical agents code (Ireland), Arbeidstilsynet limits (Norway), OSHA annotated PELs, Table Z-1 and the OSHA chemical exposure data (US), Safe Work Australia HCIS, the CSGB chemical agents regulation limits (Turkey), the MOEL exposure limits notice (Korea), NOM-010-STPS-2014 (Mexico), SUVA limit values (Switzerland), the Alberta OHS Code (Canada), and the GESTIS international limit values compilation. Not intended for drinking water, ambient air or food limits (`regaffairs_search_regulations` covers those), or for hazard classification (`regaffairs_get_ghs_hazard_classification`).

Lists what RegAffairs AI covers ("do you have the EU Cosmetics Regulation?", "which Brazil pesticide registers are in?", "what do you cover for food in the UK?"), and checks before answering that a regulation or register is available. It returns the live catalogue: dataset id, plain name, regulator, jurisdiction, industry, what it contains and when it was last refreshed. Filter by industry, jurisdiction or a text query. It does not count as a question.

Searches the wording of regulations, guidelines and register entries, for questions that need the text rather than a written answer or that fall in an area no industry tool covers, such as REACH or CLP article text, drinking water limits or industrial emissions reporting. It runs a ranked full-text search over every live dataset and returns passages with citations. It does not count as a question. Examples: REACH (`eu_reach_1907_2006`) and CLP (`eu_clp_1272_2008`) articles and annexes, US EPA drinking water MCLs (`us_epa_npdwr_contaminant_mcls`), the EU E-PRTR (`eu_eea_industrial_reporting_eprtr`). Pass `document_id` from an earlier result to read more of one document. Each dataset is searched in its own language: for a register outside the English-speaking world (Brazil, Turkey, Korea, Japan, China, Latin America and most of the EU), put the terms in that language too, for example 'arsênio arroz' for ANVISA's contaminant limits. Give query or document_id. Not intended for questions an industry tool fits; those tools return structured results.