# RegAffairs AI (remote · mcp.regaffairsai.com)

Cited answers on chemical, food, pharma, device, cosmetic and pesticide rules, linked to sources.

- Trust score: 83/100 (high trust)
- Change this week: +3
- Registry status: active
- Liveness: live
- Owner verified: no
- Last scored: 2026-11-05

## Components

- remote · `mcp.regaffairsai.com`: 83/100 (this document), [markdown](https://verifymcp.io/servers/com-regaffairsai-regaffairs/mcp.md), [page](https://verifymcp.io/servers/com-regaffairsai-regaffairs/mcp)

## Channel facts

- Endpoint: `https://mcp.regaffairsai.com/mcp`
- Transports: `streamable-http`
- Auth: `required`
- Version: `1.0.0`

## Trust breakdown

How this component scores in each security and reliability category. Every signal is checked automatically against the live server, and we only credit what we can confirm. Scores are 0–100 per category. Scoring method: https://verifymcp.io/docs/scoring (what has changed: https://verifymcp.io/docs/scoring/changelog)

Scored 2026-11-05.

- **Endpoint Security**: 92/100
  - The endpoint's TLS certificate is valid, in date, and uses a strong key.
  - Authorisation is enforced on tool calls, advertised via RFC 9728 protected-resource metadata. Discovery is public, which costs nothing: no tool can be invoked without a token.
  - HTTPS is enforced; there's no plaintext access path.
  - HSTS check failed: the Strict-Transport-Security header is absent.
  - DNSSEC check failed: this domain isn't protected by DNSSEC.
  - The authorisation server supports Client ID Metadata Documents, the current MCP client-registration mechanism.
- **Transport & Reachability**: 100/100
  - Verified streamable-http transport via a live MCP handshake.
- **Schema Quality & AI Usability**: 55/100
  - AI-judged instruction clarity (good).
  - Context-footprint check failed: tool/resource definitions use about 4705 tokens (~313/item across 15 items; 15 tools + 0 resources), over budget; trim descriptions and params.
  - Usage-examples check failed: none of the tools include examples.
- **Stability & Change Management**: 67/100
  - Stability observed for 20 of 30 days with no destabilising changes; credit accrues until the full window elapses.
- **Tool Coverage**: 90/100
  - 100% of tools have a non-trivial description (not blank, and not just the tool's name).
  - 64% of tool parameters carry a description.
  - Structured output schemas are declared (100% of tools); any adoption earns full credit.
- **Tool Safety**: 100/100
  - No prompt-injection markers were found in the server instructions, tool names or descriptions we captured.
  - We read all 15 captured tool definition(s), and no name or description among them implies an irreversible operation.
  - An AI judge read all 16 captured unit(s) of tool text and found none that tries to manipulate the model reading it.
- **Capabilities**: 100/100
  - Implements a supported MCP spec version (2025-11-25); the latest is 2026-07-28.

## Install

### How do I install the RegAffairs AI MCP server?

RegAffairs AI is a hosted endpoint at https://mcp.regaffairsai.com/mcp, so there is nothing to install locally. Ready-made configuration for Claude, Cursor, VS Code, Codex and 5 more is on this page, copied from each client's own documentation.

### Claude

```bash
claude mcp add --transport http com-regaffairsai-regaffairs 'https://mcp.regaffairsai.com/mcp'
```

### Cursor

```json
{
  "mcpServers": {
    "com-regaffairsai-regaffairs": {
      "url": "https://mcp.regaffairsai.com/mcp"
    }
  }
}
```

### VS Code

```json
{
  "servers": {
    "com-regaffairsai-regaffairs": {
      "type": "http",
      "url": "https://mcp.regaffairsai.com/mcp"
    }
  }
}
```

### Codex

```toml
[mcp_servers.com-regaffairsai-regaffairs]
url = "https://mcp.regaffairsai.com/mcp"
```

### opencode

```json
{
  "$schema": "https://opencode.ai/config.json",
  "mcp": {
    "com-regaffairsai-regaffairs": {
      "type": "remote",
      "url": "https://mcp.regaffairsai.com/mcp",
      "enabled": true
    }
  }
}
```

### OpenClaw

```bash
openclaw mcp add com-regaffairsai-regaffairs --url 'https://mcp.regaffairsai.com/mcp' --transport streamable-http
```

### Hermes

```yaml
mcp_servers:
  com-regaffairsai-regaffairs:
    url: "https://mcp.regaffairsai.com/mcp"
```

### Netclaw

```json
{
  "McpServers": {
    "com-regaffairsai-regaffairs": {
      "Transport": "http",
      "Url": "https://mcp.regaffairsai.com/mcp"
    }
  }
}
```

### Vellum

```bash
assistant mcp add com-regaffairsai-regaffairs -t streamable-http -u 'https://mcp.regaffairsai.com/mcp'
```

### Other

```json
{
  "mcpServers": {
    "com-regaffairsai-regaffairs": {
      "type": "http",
      "url": "https://mcp.regaffairsai.com/mcp"
    }
  }
}
```

The mcpServers block is a cross-client convention. Remote transports vary, so check your client's docs.

## Changelog

Every change recorded for this component, newest first. Days that predate change tracking, or that we cannot explain, say so: "we were watching and nothing happened" and "we were not watching" are different claims.

### 2026-11-04 (score 83, +1)

No change was recorded against any check on this day. Stability & Change Management went from 60 to 63. That category is still filling its 30-day observation window: 18 days of observed history at the previous scan, 19 at this one. The score rises as the window fills, whether or not the server changes.

### 2026-11-02 (score 82, +1)

No change was recorded against any check on this day. Stability & Change Management went from 53 to 57. That category is still filling its 30-day observation window: 16 days of observed history at the previous scan, 17 at this one. The score rises as the window fills, whether or not the server changes.

### 2026-10-31 (score 81, +1)

No change was recorded against any check on this day. Stability & Change Management went from 47 to 50. That category is still filling its 30-day observation window: 14 days of observed history at the previous scan, 15 at this one. The score rises as the window fills, whether or not the server changes.

### 2026-10-28 (score 80, +1)

No change was recorded against any check on this day. Stability & Change Management went from 37 to 40. That category is still filling its 30-day observation window: 11 days of observed history at the previous scan, 12 at this one. The score rises as the window fills, whether or not the server changes.

### 2026-10-26 (score 79, +1)

No change was recorded against any check on this day. Stability & Change Management went from 30 to 33. That category is still filling its 30-day observation window: 9 days of observed history at the previous scan, 10 at this one. The score rises as the window fills, whether or not the server changes.

### 2026-10-24 (score 78, +1)

No change was recorded against any check on this day. Stability & Change Management went from 23 to 27. That category is still filling its 30-day observation window: 7 days of observed history at the previous scan, 8 at this one. The score rises as the window fills, whether or not the server changes.

### 2026-10-22 (score 77, +1)

No change was recorded against any check on this day. Stability & Change Management went from 17 to 20. That category is still filling its 30-day observation window: 5 days of observed history at the previous scan, 6 at this one. The score rises as the window fills, whether or not the server changes.

### 2026-10-20 (score 76, +1)

No change was recorded against any check on this day. Stability & Change Management went from 10 to 13. That category is still filling its 30-day observation window: 3 days of observed history at the previous scan, 4 at this one. The score rises as the window fills, whether or not the server changes.

## MCP tools (15)

### `regaffairs_ask_question` (~351 tokens)

Ask a regulatory question (full cited answer)

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.

Input parameters:

- `industry` (string): Optional hint.
- `jurisdictions` (array): Optional ISO codes to focus on, e.g. ["EU","GB","US","US-CA","TR","CA","BR"].
- `question` (string, required): The question in the user's words. Include substance names with CAS/EC numbers, the product type and the market when known.

Output parameters:

- `answer_id`
- `answer_markdown`
- `answer_url`
- `datasets_searched` (array)
- `message` (string)
- `sources` (array)
- `status` (string)
- `truncated` (boolean)
- `web_sources_used` (boolean)

### `regaffairs_get_answer_status` (~87 tokens)

Get the status of a running answer

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.

Input parameters:

- `answer_id` (string, required)

Output parameters:

- `answer_id`
- `answer_markdown`
- `answer_url`
- `datasets_searched` (array)
- `message` (string)
- `sources` (array)
- `status` (string)
- `truncated` (boolean)
- `web_sources_used` (boolean)

### `regaffairs_search_regulations` (~353 tokens)

Search regulation text and source documents

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.

Input parameters:

- `datasets` (array): Optional dataset ids to restrict the search (from regaffairs_list_covered_regulations).
- `document_id` (string): Read passages from one document returned earlier. Give query or document_id.
- `industry` (string)
- `jurisdictions` (array)
- `limit` (integer)
- `query` (string): What to search for, in the dataset's language when it is not English. Give query or document_id.

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `truncated` (boolean)

### `regaffairs_list_covered_regulations` (~136 tokens)

List the regulations and datasets covered

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.

Input parameters:

- `industry` (string)
- `jurisdictions` (array)
- `limit` (integer)
- `query` (string)

Output parameters:

- `datasets` (array)
- `total` (integer)
- `truncated` (boolean)

### `regaffairs_check_chemical_substance` (~381 tokens)

Check a chemical substance: REACH, SVHC, TSCA, Prop 65 status

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).

Input parameters:

- `identity_only` (boolean): Only resolve name, CAS and EC (for ambiguous names, salts, hydrates, group entries).
- `jurisdictions` (array): Default: all.
- `lists` (array): Default: all lists for the chosen jurisdictions.
- `substances` (array, required): Names, CAS (e.g. 80-05-7) or EC numbers (e.g. 201-245-8).

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `truncated` (boolean)

### `regaffairs_get_ghs_hazard_classification` (~347 tokens)

Get GHS/CLP hazard classification, label elements and UN number

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).

Input parameters:

- `include_notified` (boolean): Add the C&L Inventory notified classifications.
- `include_pending` (boolean): Add open CLH intentions and RAC opinions.
- `include_transport` (boolean): Add the US DOT 49 CFR 172.101 entry (UN number, class, packing group).
- `jurisdictions` (array)
- `substance` (string, required): Name, CAS, EC, CLP index number or UN number (e.g. UN1090).

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `transport` (array)
- `truncated` (boolean)

### `regaffairs_get_workplace_exposure_limits` (~324 tokens)

Get workplace exposure limits (OEL, WEL, PEL, AGW, VLEP)

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`).

Input parameters:

- `countries` (array): Default: all held. INTL = the GESTIS international compilation; CA-AB = Alberta.
- `limit_types` (array): Default: all.
- `substance` (string, required): Name, CAS or EC number.

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `truncated` (boolean)

### `regaffairs_check_food_additive_or_ingredient` (~352 tokens)

Check a food additive, colour, novel food or food contact substance

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`).

Input parameters:

- `contact_material` (string): For food contact questions.
- `food_category` (string): Optional, e.g. 'flavoured drinks', 'confectionery' or EU category 14.1.4.
- `ingredient` (string, required): Name, E-number (e.g. E171), INS number, FD&C name (e.g. Red No. 3) or CAS.
- `jurisdictions` (array)
- `regime` (string)

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `truncated` (boolean)

### `regaffairs_check_food_label_and_allergens` (~317 tokens)

Check food labelling, allergen and health claim rules

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`).

Input parameters:

- `detail` (string): The allergen, claim wording, nutrient or particular, e.g. 'sesame', 'vitamin C contributes to the normal function of the immune system'.
- `food_type` (string): Optional, e.g. 'prepacked', 'prepacked for direct sale', 'non-prepacked', 'infant formula', 'food supplement'.
- `jurisdictions` (array)
- `topic` (string, required)

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `truncated` (boolean)

### `regaffairs_check_cosmetic_ingredient` (~270 tokens)

Check a cosmetic ingredient (banned, restricted, max concentration, INCI)

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).

Input parameters:

- `application` (string)
- `for_children_under_3` (boolean)
- `function` (string): Optional, narrows to the matching annex.
- `ingredient` (string, required): INCI name, common name, CAS or EC.
- `jurisdictions` (array)
- `product_type` (string): Optional, e.g. 'face cream', 'hair dye', 'oral care', 'sunscreen', 'spray', 'eye area'.

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `truncated` (boolean)

### `regaffairs_check_pesticide_approval_and_mrl` (~274 tokens)

Check pesticide approval status and maximum residue levels (MRLs)

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.

Input parameters:

- `active_substance` (string, required): Active substance name or CAS, e.g. 'glyphosate'.
- `crop` (string): For MRLs or tolerances, e.g. 'wheat', 'peaches', 'table grapes'.
- `include` (array)
- `jurisdictions` (array)

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `truncated` (boolean)

### `regaffairs_check_biocide_active_substance` (~382 tokens)

Check a biocide active substance, product type or disinfectant registration

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).

Input parameters:

- `active_substance` (string): Active substance name or CAS, e.g. 'permethrin', 'hydrogen peroxide'. Give active_substance or product_name.
- `include_suppliers` (boolean): Add Article 95 supplier entries.
- `jurisdictions` (array)
- `product_name` (string): Biocidal product or disinfectant name, or an EPA registration number. Give active_substance or product_name.
- `product_type` (string): e.g. 'PT18' (insecticides), 'PT8' (wood preservatives).
- `target_pathogen` (string): For US disinfectant lists, e.g. 'SARS-CoV-2', 'norovirus', 'C. difficile'.

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `truncated` (boolean)

### `regaffairs_find_pharma_gmp_and_ich_guidance` (~384 tokens)

Find pharma GMP and ICH guidance (EU GMP, cGMP, ICH, CTD)

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.

Input parameters:

- `guideline` (string): Code or annex, e.g. 'Annex 1', 'Q9(R1)', 'Q1A(R2)', 'M7', '211.192'. Give query, guideline or site_or_company.
- `query` (string): The GMP or ICH topic, e.g. 'contamination control strategy', 'stability testing zones', 'nitrosamine risk assessment'. Give query, guideline or site_or_company.
- `site_or_company` (string): For MHRA licence lookups: company or site name, or licence number. Give query, guideline or site_or_company.
- `source` (string)

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `truncated` (boolean)

### `regaffairs_check_drug_or_device_approval` (~285 tokens)

Check a drug or medical device approval, classification or shortage

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.

Input parameters:

- `include` (array)
- `jurisdictions` (array): Default: all held for the product kind.
- `product` (string, required): Medicine brand or active ingredient, DIN, NDA/ANDA number, device name, FDA product code (e.g. 'DXY'), PMA number or notified body number.
- `product_kind` (string)

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `truncated` (boolean)

### `regaffairs_check_textile_restricted_substances` (~339 tokens)

Check textile restricted substances and labelling (ZDHC, OEKO-TEX, REACH)

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).

Input parameters:

- `jurisdictions` (array)
- `lists` (array): Default: all.
- `product_class` (string): OEKO-TEX product class I to IV.
- `substances` (array): Names, CAS numbers or substance groups, e.g. 'APEOs', 'PFAS', 'azo dyes', '117-81-7'. Give substances or topic.
- `topic` (string): What to check. Give substances or topic; substances without a topic are checked as restricted_substances.

Output parameters:

- `not_found` (array)
- `results` (array)
- `sources` (array)
- `truncated` (boolean)

## Diagnostics

Captured diagnostic sections: TLS, DNSSEC, Authorisation, Transports. The full working is on the page: https://verifymcp.io/servers/com-regaffairsai-regaffairs/mcp#diagnostics

## Score history

- 2026-11-05: 83
- 2026-11-04: 83
- 2026-11-03: 82
- 2026-11-02: 82
- 2026-11-01: 81
- 2026-10-31: 81
- 2026-10-30: 80
- 2026-10-29: 80
- 2026-10-28: 80
- 2026-10-27: 79
- 2026-10-26: 79
- 2026-10-25: 78
- 2026-10-24: 78
- 2026-10-23: 77
- 2026-10-22: 77
- 2026-10-21: 76
- 2026-10-20: 76
- 2026-10-19: 75
- 2026-10-18: 75
- 2026-10-17: 74
- 2026-10-16: 74
- 2026-10-15: 37
- 2026-10-14: 37
- 2026-10-13: 37
- 2026-10-12: 37
- 2026-10-10: 37

## Common questions

### What is the RegAffairs AI MCP server?

RegAffairs AI is an MCP server listed in the public MCP registry as com.regaffairsai/regaffairs. Cited answers on chemical, food, pharma, device, cosmetic and pesticide rules, linked to sources. This page covers its hosted endpoint (https://mcp.regaffairsai.com/mcp).

### Is the RegAffairs AI MCP server safe to use?

RegAffairs AI scores 83 out of 100 on VerifyMCP. That is a record of what we were able to check automatically, not an endorsement. The category breakdown on this page shows every signal behind the number, including the ones we could not confirm.

### What tools does the RegAffairs AI MCP server expose?

RegAffairs AI exposes 15 tools: regaffairs_ask_question, regaffairs_get_answer_status, regaffairs_search_regulations, regaffairs_list_covered_regulations, regaffairs_check_chemical_substance, and 10 more. Their descriptions and schemas cost roughly 4,582 tokens of context every time the server is loaded.

### Does the RegAffairs AI MCP server require authentication?

Yes. RegAffairs AI asked us for credentials when we connected, so you will need to authorise it in your MCP client before it can do anything.

### Is the RegAffairs AI MCP server still maintained?

RegAffairs AI is still listed as active in the MCP registry. We last reached this channel on 5 November 2026. Those dates come from our own scans of the registry and the channel itself, not from anything the publisher announced.

## Links

- Remote endpoint: https://mcp.regaffairsai.com/mcp
- Website: https://regaffairsai.com/docs/mcp
- Changelog RSS feed: https://verifymcp.io/servers/com-regaffairsai-regaffairs/mcp.xml
- Changelog JSON feed: https://verifymcp.io/servers/com-regaffairsai-regaffairs/mcp.json
- HTML version of this page: https://verifymcp.io/servers/com-regaffairsai-regaffairs/mcp