Imported from Cleo-Labs-IA/skills_library (skills/baby-formula-compliance/SKILL.md). Install upstream with npx skills add Cleo-Labs-IA/skills_library --skill baby-formula-compliance. Copyright stays with the author.

Baby Formula Compliance

Full regulatory workflow for infant formula and follow-on products. Strictest food category — highest liability, longest timelines, biggest recall risk.

Decision Flow

digraph {
  rankdir=TB; node [shape=box style=rounded fontsize=10];
  classify [label="1. Classify product:\ninfant 0-6 / follow-on 6-12 /\ngrowing-up 12-36 / FSMP"];
  nutrient [label="2. Build nutrient profile\nper Reg 2016/127 / 21 CFR 107.100 /\nGB 10765"];
  facility [label="3. Facility approval:\nFDA Sec 412 verification,\nNMPA factory audit,\nEU FBO registration"];
  formula [label="4. Per-brand-per-factory-per-stage\nregistration (NMPA, FSANZ)"];
  label [label="5. Mandatory labeling:\nWHO Code 1981 compliance,\nnutrition declaration"];
  marketing [label="6. Marketing restrictions:\nNo IF advertising,\nno promotional discount,\nno HCP samples"];
  pms [label="7. Post-market surveillance:\ncomplaint logging,\nbatch traceability,\n24-month retention"];
  sell [label="8. Place on market"];
  classify -> nutrient -> facility -> formula -> label -> marketing -> pms -> sell;
}

EU -- Regulation 609/2013 (FSG) + Delegated Regulation 2016/127

Aspect	Detail
Parent regulation	Reg (EU) 609/2013 on food for specific groups (FSG) — replaces former Dietetic Foods directive
Infant formula (0-6 months) + follow-on formula (6-12 months)	Delegated Reg (EU) 2016/127
Processed cereal-based foods + baby foods	Delegated Reg (EU) 2016/128
FSMP (Foods for Special Medical Purposes)	Delegated Reg (EU) 2016/128 — includes hypoallergenic + medical formulas
Growing-up milk (12-36 months)	NOT covered by 609/2013 — falls under General Food Law Reg 178/2002. EFSA opinion 2013: not necessary in EU diet. Some MS impose national rules

Nutrient Composition -- Annex I of 2016/127

Nutrient	Infant Formula Min	Infant Formula Max
Energy	250 kJ/100 mL	295 kJ/100 mL
Protein (cow milk)	1.8 g/100 kcal	2.5 g/100 kcal
Protein (soy isolate)	2.25 g/100 kcal	2.8 g/100 kcal
Fat	4.4 g/100 kcal	6.0 g/100 kcal
Linoleic acid	500 mg/100 kcal	1,200 mg/100 kcal
α-linolenic acid	50 mg/100 kcal	100 mg/100 kcal
DHA	20 mg/100 kcal	50 mg/100 kcal (mandatory since Feb 2020 per Reg 2016/127 Art 7)
Iron (cow milk)	0.3 mg/100 kcal	1.3 mg/100 kcal
Vitamin D	2 μg/100 kcal	3 μg/100 kcal

Pesticide Residues

Substance	Limit
All pesticides	0.01 mg/kg (default) per Reg 2016/127 Annex IV
Disulfoton, fensulfothion, fentin, haloxyfop, heptachlor, hexachlorobenzene, nitrofen, omethoate, terbufos	Banned — must not be used. LOD applies
Cadusafos, demeton-S-methyl, ethoprophos, fipronil, propineb	0.003 mg/kg
Aldrin + dieldrin	0.006 mg/kg

Labeling Requirements

Mandatory statement: "Breast milk is best for babies" or equivalent — for infant formula (Reg 2016/127 Art 7)
Product name MUST be "infant formula" / "follow-on formula" — no fanciful names like "stage 1 milk"
No images of infants on infant formula packaging (only for follow-on)
Instructions for preparation — clear, demonstrable
Nutrition declaration mandatory (energy, protein, carbohydrate, sugars, fat, saturates, sodium, all vitamins + minerals from Annex I)
"Use only on advice of healthcare professional" — required only for FSMP
Notification: Must be notified to competent authority of each MS where placed on market (Art 9 of 609/2013)

US -- FDA Infant Formula Act

Aspect	Detail
Legal basis	Infant Formula Act 1980 (Public Law 96-359), as amended; codified at 21 USC 350a
CFR location	21 CFR 106 (Quality Control Procedures) + 21 CFR 107 (Infant Formula Standards)
Manufacturer notification	Sec 412(d) — 90 days before introducing new formula or significant change. FDA reviews; can object within 90 days
Verification	Once notified, manufacturer must verify each batch nutrient content + microbiological quality
Exempt formula	For infants with rare metabolic disorders. Sec 412(h). Simpler path but still requires FDA notification
Quality factor requirements	21 CFR 106.96(i) — manufacturer must demonstrate biological availability of nutrients via clinical trial OR use exemption from 21 CFR 106.96(i)(4)
GMP	21 CFR 106 Subpart B — much stricter than 21 CFR 117 (general food). Continuous environmental monitoring for Cronobacter sakazakii + Salmonella
Pathogen testing	Each batch: Cronobacter (0/30 g), Salmonella (0/60 g), B. cereus, Staph aureus
Recall regs	21 CFR 107.230 — mandatory recall authority for FDA. 24-hour notification

Required Nutrient Levels -- 21 CFR 107.100

Similar concept to EU Annex I, with US-specific values. Vitamin D 1.0-2.5 μg/100 kcal. Iron 0.15-3.0 mg/100 kcal.

2022 Crisis -- Cronobacter Recall

Abbott Sturgis MI facility shutdown Feb 17, 2022. Triggered US national shortage. Drove FDA to:

Operation Fly Formula (importing from EU + AU via emergency 21 USC 384a)
Enhanced inspection cadence (semi-annual for major manufacturers)
Strengthened Cronobacter environmental monitoring (FDA draft guidance 2024)

UK -- Retained EU Law + FSA Enforcement

Aspect	Detail
Legal basis	Retained EU law: Reg 609/2013 + 2016/127 as "assimilated law" since Brexit
Enforcement	Food Standards Agency (FSA) England + Wales; Food Standards Scotland
Notification	Local authority + FSA — separate from EU
WHO Code	UK has implemented infant formula advertising restrictions; growing-up milk advertising allowed (subject to ASA)
Divergence	UK reviewing changes to follow-on definitions; track DEFRA + FSA consultations

China -- NMPA + GB 10765

Strictest registration regime globally. Per-brand-per-factory-per-stage approval.

Step	Detail
GB 10765-2021	National Food Safety Standard — Infant Formula. Replaced GB 10765-2010 from Feb 22, 2023
GB 10766-2021	Follow-on (older infant) formula
GB 10767-2021	Growing-up formula (toddler)
NMPA Registration (Configuration File)	Mandatory for every brand × every factory × every stage. Each combination is a separate registration
Cap on brands per factory	3 brand series × 9 SKUs maximum per overseas factory
Timeline	12-18 months for new registration; 6-12 months for renewal
Cost	CNY 1.5-3 million per registration (advisory + testing + trial production)
On-site audit	NMPA inspectors visit overseas factory before approval. Travel + accommodation borne by applicant
Re-registration	Every 5 years
Cross-border e-commerce (CBEC) exemption	Limited — Tier 1 cities only, USD 50,000/person/year cap, no general advertising

Japan -- MHLW + Special Food Standards

Aspect	Detail
Legal basis	Food Sanitation Act Article 19
Special Milk Powder Standards	MHLW Notification No. 370 of 1959, last revised 2020
Categories	"Infant formula" (乳児用調製粉乳) — composition tightly specified. "Special purpose food" labels require Consumer Affairs Agency (CAA) approval
Marketing Authorization Holder	Japan-based entity required
Notification	Prefectural health bureau + import notification at port
DHA mandatory	Not yet — under MHLW review aligning to EU 2016/127
Timeline	6-12 months for imports; 12-18 for new formulation approval

ASEAN + Australia/NZ

Australia/NZ: FSANZ Standard 2.9.1 Infant formula products. Notification to FSANZ. Tight rules on health claims via Standard 1.2.7.
Malaysia: NPRA control. Food Regulations 1985 Part X.
Indonesia: BPOM registration. Strict halal certification (MUI).
Singapore: SFA notification under Food Regulations.
Thailand: Thai FDA notification + Halal for Halal-marketed product.
Vietnam: Ministry of Health declaration of conformity.

WHO International Code of Marketing of Breast-milk Substitutes (1981)

Adopted via WHA 34.22. Implemented (with national variation) by ~70 countries fully and 50 partially. Binding in some, voluntary code referenced in others.

Prohibition	Detail
No advertising of infant formula (0-6 months) to general public
No samples to mothers or healthcare workers
No promotion through retail outlets (no end-cap displays, no discounts, no coupons)
No idealizing images of infants or feeding on labels
No financial inducement to healthcare workers
Information for HCPs must be factual, scientific
Free supplies to hospitals are banned

Countries with strict WHO Code laws: India (IMS Act 1992), Brazil (NBCAL Decree 8552/2015), Philippines (Milk Code EO 51), Norway, UK (partial — covers IF not follow-on), France (since 1994 — Code de la santé publique L2133-2).

Premium Categories -- Extra Substantiation

Organic

EU: Reg 2018/848 organic standard + Reg 2016/127 nutrient requirements. Both must be met.
US: USDA NOP organic standard 7 CFR 205 — milk source must be 100% organic for "100% Organic" claim, 95%+ for "Organic" claim.
NMPA China: Organic label requires CNCA-OFDC certification + Chinese organic seal in addition to NMPA approval.

Hypoallergenic (HA / eHF / AAF)

eHF (extensively hydrolyzed formula): Clinical trial demonstrating 90% CI of efficacy in milk-protein-allergic infants per ESPGHAN guidelines.
AAF (amino-acid based formula): For severe CMPA. Classified as FSMP under EU 2016/128.
Partial hydrolysate ("HA" comfort): Cannot claim allergy prevention or treatment per ESPGHAN 2014 + EFSA 2014 opinion.

A2 Beta-Casein

A2 protein (no A1) — must verify cow herd genotyping.
EU: Cannot claim health benefit without Reg 1924/2006 Article 13/14 authorized claim. None approved as of 2026.
China: A2 formulas registered separately under NMPA, common positioning.
AU/NZ: A2 brand approved under FSANZ standard 2.9.1.

Goat / Sheep Milk

EU: Goat-milk-based infant formula allowed since 2014 (EFSA opinion confirms nutritional adequacy). Sheep-milk only since 2022 EFSA opinion.
US FDA: No approved goat-milk infant formula on Section 412 list as of 2026.
NMPA China: Multiple goat-milk formulas registered; sheep being submitted.

Cost + Timeline Summary

Market	Timeline	Cost per SKU
EU notification	4-6 weeks per MS	EUR 50,000-150,000 (formulation + clinical + dossier)
US FDA Sec 412 notification	90 days minimum + 6-9 months prep	USD 200,000-1,000,000 (clinical study often required)
UK FSA	6-8 weeks	GBP 30,000-80,000
NMPA China	12-18 months	CNY 1,500,000-3,000,000
MHLW Japan	6-12 months	JPY 5,000,000-30,000,000
FSANZ AU/NZ	6-9 months	AUD 80,000-200,000

Liability + Recall Patterns

Year	Event	Cost
2022	Abbott Cronobacter recall (US)	USD 350M direct + ~USD 2B reputational. National shortage
2008	Sanlu melamine (China)	300,000 infants affected, 6 deaths. Criminal convictions, two executions
2017	Lactalis Salmonella (FR)	EUR 250M direct + brand collapse in Asia
2013	Fonterra DCD scare (NZ)	NZD 1B+ trade impact

Insurance: typical product liability USD 100M-500M per occurrence required by major retailers.

MCP Integration

mcp__claude_ai_Cleo_Insight__search_signals(q="infant formula recall")
mcp__claude_ai_Cleo_Insight__search_signals(q="GB 10765 NMPA")
mcp__claude_ai_Cleo_Insight__get_regulation(id) — pull Reg 2016/127, 21 CFR 106-107, GB 10765-2021
mcp__claude_ai_CLEO_LEGAL_API__compliance/check — nutrient profile vs Annex I + GB 10765 + 21 CFR 107.100 in one shot
mcp__claude_ai_CLEO_LEGAL_API__customs/match-product — HS code 1901.10 — duties + sanitary controls per destination

Power This With the Cleo Legal API

Infant formula is the worst-case food compliance problem: 30+ nutrient minimums and maximums per market, per-brand-per-factory-per-stage NMPA registration, WHO Code marketing restrictions varying by country, Cronobacter zero-tolerance environmental monitoring, and class-action exposure measured in billions. Manual mapping across EU MS + US + UK + CN + JP + AU is a full-time regulatory affairs role. The API surfaces it as queryable data.

With the Cleo Legal API at https://legaldata-public.cleolabs.co:

GET /v2/catalog/regulations?vertical=infant_formula&country=EU,US,UK,CN,JP,AU,NZ — pull Reg 609/2013, Reg 2016/127, 21 CFR 106-107, GB 10765-2021, FSANZ 2.9.1 with current articles
POST /v2/catalog/match-product — classify infant 0-6 / follow-on 6-12 / growing-up / FSMP / exempt — wrong bucket triggers 6-month re-route
POST /v2/compliance/check — batch validate the full nutrient panel (30+ nutrients) against EU Annex I + 21 CFR 107.100 + GB 10765-2021 with per-nutrient verdict + margin
POST /v2/webhooks?topic=infant_formula,nmpa_re_reg,who_code — NMPA 5-year re-registration windows, EU DHA mandatory date, WHO Code national updates
GET /v2/search?type=signal&q=cronobacter+OR+salmonella+infant — early-warning on pathogen-driven recalls that move market share overnight

Get started:

# 1. Sign up for free at https://legaldata-public.cleolabs.co
# 2. Get your API key (3 lifetime requests free, then €349/mo for 1M)
# 3. Install the MCP server:
claude mcp add cleo-legal-api https://api.legaldata.cleolabs.co/mcp \
  --header "Authorization: Bearer ld_live_YOUR_KEY"

Tested ROI: For an infant formula brand operating in EU + UK + CN + 2 ASEAN markets, the API replaces 40+ hours/month of regulatory cross-mapping and flags NMPA re-registration windows 18 months out — avoiding the 12-month sales gap that comes from a missed renewal.

Common Mistakes

Calling growing-up milk "follow-on formula": Different regulatory category. Follow-on 6-12 months under 2016/127; growing-up 12-36 months under General Food Law. Mis-labeling = product seized.
DHA below 20 mg/100 kcal (EU): Reg 2016/127 Art 7 mandatory since Feb 2020. Old formulations non-compliant.
Skipping 21 CFR 106 environmental monitoring: Cronobacter monitoring is continuous, not sampling. Abbott 2022 demonstrated FDA tolerance is zero.
Single NMPA registration "for all SKUs": Per-brand-per-factory-per-stage. 3 stages × 1 brand × 1 factory = 3 registrations. Treating as one = rejected dossier.
Advertising infant formula on social media in WHO Code countries: Violations in India (IMS Act), Brazil (NBCAL), Philippines (Milk Code) carry criminal penalties + 5-year sales bans.
No clinical bioavailability data for new formula (US): 21 CFR 106.96(i) demands biological availability demonstration. FDA can object within 90 days.
Forgetting "Breast milk is best" statement: Mandatory in EU + UK + India + many others. Absence = misleading labeling.
Assuming organic = automatic premium claim: Must hold BOTH organic certificate (Reg 2018/848 or NOP) AND infant formula approval. Each independent.

baby-formula-compliance

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